Names have been removed (except the expert who advised on this case) to protect privacy. Identifying letters are assigned in alphabetical order and bear no relationship to the person's actual name.
Mr and Mrs A complained to the Commissioner concerning the treatment provided to their son, Master A, by Dr B, Staff Nurse (SN) C, Staff Nurse (SN) D and a Public Hospital. The complaint is that :
On 21 April 1998 staff at the Public Hospital did not provide services of an appropriate standard to Master A during the administration of a charcoal substance to absorb Pamol.
Further to this, the complaint is that Mr and Mrs A were not informed of the risks of the procedure prior to it being carried out on Master A.
The complaint was received by the Commissioner on 14 August 1998. An investigation was commenced on 8 November 1998. Information was obtained from:
Mr and Mrs A Parents / Complainants
Dr B Accident and Emergency Medical Officer / Provider
Mr C Staff Nurse / Provider
Ms D Staff Nurse / Provider
Dr E Chief Medical Officer / Public Hospital
Mr F Legal advisor, New Zealand Nurses Organisation
Ms G Chief Executive Officer, Public Hospital
Medical records relating to the treatment of Master A were obtained and reviewed. Police files and a Coroner's report were also considered. The Commissioner sought advice from an independent emergency medicine specialist and, upon receipt of responses to the provisional opinion, sought further advice from an independent nursing specialist.
Information Gathered During Investigation
A few days prior to 21 April 1998 Master A, aged two years, four months, had been unwell and was prescribed 250mg/5ml Pamol by a city general practitioner. The Pamol was dispensed in a 500ml bottle with a child-proof cap. During the night of 20/21 April 1998 Master A vomited in bed. His parents, Mr and Mrs A, gave Master A 5mls of Pamol and put him back to bed.
At around 7.30am on 21 April 1998 Mrs A found Master A in the kitchen pouring Pamol into a spoon. There was Pamol on the bench, floor, around his mouth and in the spoon. Mr A stated to the Commissioner that two "Handy" paper towels were required to remove excess Pamol from around Master A.
Master A appeared normal and his parents had no immediate concerns for him. After a brief discussion Mr and Mrs A rang the National Poisons Centre.
The Poisons Centre questioned and determined that approximately 125ml of Pamol was missing from the bottle. Given that Master A weighed 16kg the Poisons Centre calculated that he would only need to have swallowed 32mls for there to be a problem. Mr and Mrs A were therefore advised to take Master A to the Emergency Department at the Public Hospital.
The Poisons Centre Treatment Guideline (and the Public Hospital protocol) states :
"Ingested dose < 125mg/kg or if dose unknown :
- Administer single dose activated charcoal if Paracetamol liquid or tablets ingested within 2 or 4 hours respectively.
- Determine blood to Paracetamol levels (at 4 hours according to the Roumac - Matthew nomogram for single acute Paracetamol poisoning).
- If blood Paracetamol level above treatment line, commence N - Acetyl Cysteine (NAC).
- Emergency Measures :
1) Stabilisation - support respiratory and cardio vascular function;2) Decontamination - emesis and lavage not recommended.3) Activated charcoal : single dose activated charcoal is the recommended gastrointestinal decontamination procedure : Single dose regimen : Adult 50-100gms; Child 1-2gms per kg. The majority of children will tolerate an oral dose of activated charcoal if given in an encouraging and positive manner, preferably in the presence of a parent/caregiver. For the few children refusing an oral dose, administration using a nasogastric tube should be undertaken."
The family arrived at the Public Hospital Emergency Department at about 8.00am and were met by Staff Nurse C. SN C determined Master A may have had up to 125ml of Pamol and weighed 14kg. SN D joined SN C and the two nurses conferred and concluded that treatment was required and that a medical officer should be consulted.
SN C consulted the Poisons Folder and found the Public Hospital Protocol entitled "Gastrointestinal Decontamination (Children)". SN D and SN C determined that their treatment plan was for activated charcoal orally at a dose of 1-2mg/kg (120ml of the 50g/300ml preparation).
Dr B, Accident and Emergency Medical Officer, was summoned and SN C passed on the information that had been collected. Dr B re-calculated the figures calculated by SN D and SN C and decided that 120ml of a standard solution of activated charcoal in sterile water needed to be administered as treatment. Dr B and SN C agreed they would attempt to administer this orally and if this failed to deliver it through a nasogastric tube.
Dr B, in his Coroner's deposition, stated that :
"Satisfied that situation was being appropriately handled, I left the nurses to try to persuade [Master A] (with his parents) to drink the charcoal and did not go in to meet them. I hoped that the nurses and parents would be successful in persuading [Master A] to drink what is an unpleasant mixture."
Master A was initially encouraged by the nursing staff to ingest the solution orally. Master A drank a small quantity but refused to drink any more. SN C consulted Dr B and SN D and a decision was made to administer the substance through a nasogastric tube.
Dr B observed that of the 120ml charcoal previously prepared approximately 20ml was missing from the cup. In his Coroner's deposition, Dr B stated :
"I went in and introduced myself to [Master A's] parents and [Master A]. I confirmed from them that the information given to me by the nurses, particularly regarding the quantity of Pamol consumed. I explained why we needed to insert a nasogastric tube."
At the Coroner's inquest held during November 1998 Dr B was subject to cross-examination by the Coroner. During this cross-examination Dr B stated :
"Coroner : At the time you had that discussion did you have any perception that the process of introducing carbon into [Master A's] body by tube was itself risky?Dr [B] : I knew there were some risks involved as in any medical procedure. But I honestly thought they were very low.Coroner : What did you see the risks as being then?Dr [B] : I didn't have any numbers in my head. I just thought it was very low and I recall I may have mentioned this to Mr and Mrs A that it is quite a common procedure in hospitals for giving charcoal like this and also in newborn units and maternity units for giving milk to babies who are having trouble sucking or drinking or whatever.Coroner : Did you in your mind address the risks of aspiration?Dr [B] : No can ...Coroner : Did you address in your mind the risks of aspiration?Dr [B] : That's also in your mind that is why you make sure the tube is in the right position when you do the procedure.Coroner : What about the risks of aspiration from regurgitation?Dr [B] : I don't remember thinking specifically about that, This is on my recollection of 6 and a half months ago.Coroner : Had you known that as a risk of the procedure?Dr [B] : Yes.Coroner : When you were addressing the risks that [Master A] was then exposed to, is it fair to say that you put greater weight on the risk that he was exposed to from the paracetamol than you put on the risks that he was exposed to from the procedures you were about to undertake?Dr [B] : Yes if I really felt the risk of the charcoal was that much higher I wouldn't have done it.Coroner : Did you give the parents any comment on the risks of the procedure?Dr [B] : No, and in retrospect I wish I had balanced the risk of the procedure with the risk from paracetamol accidental ingestion and really helped them to make the decision. I guess I was driven by the way we treat paracetamol accidental poisoning from a variety of sources. I meant medical information.Coroner : If [Master A] had not had the charcoal solution administered to him, what did you perceive may have happened?Dr [B] : What we would have done and what I was going to do had not this terrible business have happened would have been to put some anaesthetic cream over a vein and get his parents to take him away and bring him back over 4 hours and take a blood level. I mean 4 hours post ingestion from 7.30 am. Then we would have acted on the paracetamol blood level to the standard curve that is available (graph) from a number of sources and seeing if treatment was necessary with the antidote. The antidote being NAC [N-Acetyl Cysteine].Coroner : Did you have NAC in the hospital and available?Dr [B] : We keep it in the cupboard next to the charcoal with the few other antidotes we have for other chemicals....Coroner : Did the parents authorise the procedure or did you just assume it was authorised and carried on?Dr [B] : ... we had that brief conversation I guess it was one of those situations which happen often in this job where there is no formal agreement but I felt there was the intent to continue."
SN D in her Coroner's deposition recalls :
"Dr [B] came in during this time. I remember Dr [B] saying we'll give the child some charcoal."
Master A was positioned horizontally across a hospital bed. SN C and SN D wrapped Master A in a blanket to restrain his arms. SN C held Master A's head and SN D held his body. Mr A assisted with holding Master A still.
Having estimated the length of the tube needing to be inserted by measuring it against Master A, Dr B passed the nasogastric tube via Master A's left nostril. According to Dr B the tube was fed to the length pre-determined with ease and on the first attempt. Dr B in his Coroner's deposition stated :
"I checked [Master A's] mouth to ensure the tube had not come out of his mouth as can sometimes happen. His mouth was clear. I then checked the position of the tube."
Dr B attached a 50ml syringe to the nasal end of the nasogastric tube and attempted to aspirate gastric secretions to determine that the tube was placed in the stomach. However, this was unsuccessful, as he could not withdraw any gastric contents to enable him to perform a litmus test.
Dr B stated that he passed his stethoscope under the blanket and listened over Master A's epigastrium while injecting some air into the tube. Mr A stated to the Commissioner that he could not recall Dr B using a stethoscope and advised that Master A was wearing three layers of clothing, which Dr B did not remove during the procedure. Dr B was noted by all present to indicate that he was satisfied that the tube was in the stomach following this manoeuvre. Dr B states in his Coroner's deposition :
"I listened as air was pushed into the tube by the syringe and I was able to satisfy myself that there was a temporal (time) relationship between the expected sound that I was hearing over the epigastrium [upper central region of the abdomen] and the administration of air via the syringe."
SN D in her Coroner's deposition recalls :
"Dr [B] put the stethoscope down the 'cuddly' to listen to the stomach while he inserted air down the tube. He told us he was happy that it was in the stomach and started to put charcoal into the syringe. The child wriggled and at some point put his hand out which I re-wrapped."
Dr B then loaded the syringe with half the charcoal needing to be installed and injected this via the nasogastric tube. The nursing staff reported that Master A was not coughing, gagging or vomiting at this time. However, he was noted to be moving and "grinding his teeth".
The second syringe full was delivered in a similar manner, the procedure taking about 30 seconds. SN D in her Coroner's deposition recalls :
"I tried to comfort Dad who was obviously distressed. He let go of the child and stood back a little. I held the child. Dr [B] said 'Turn him towards me on his side'. The child ground his teeth."
SN C in his deposition recalls :
"At some time during the procedure Dr [B] asked us to put the child on his side and we did keeping the child restrained. The child didn't look abnormally distressed. When Dr [B] had finished he pulled the nasogastric tube out.Dr [B] then withdrew the nasogastric tube and lifted [Master A] off the stretcher, handing him to SN [D] who held him only shortly before handing on to his father to hold."
At this point Master A began to make gasping sounds. Mr A noted that Master A was pale and not breathing and notified SN D. SN D also noted that Master A had evidence of circumoral cyanosis (turning blue around the mouth).
SN D took Master A from his father and informed the team that there was a problem. They went to the resuscitation room and immediately began to initiate resuscitation, including a team call out.
Dr B states in his Coroner's deposition :
"I also noted there was no charcoal around his nose or mouth. [Master A] was placed on the bench. He started to cough and splutter. It was at this point charcoal began to emerge from his nose and mouth."
At this point, Master A was noted by Dr B to have an oropharynx (middle portion of the throat) full of charcoal solution that was running up from his oesophagus and apparently obstructing his airway.
Dr B attempted to establish a direct airway but was unable to do so due to the charcoal obstructing his pressing of Master A's airway. Dr B continued to aspirate charcoal from Master A's oropharynx in an attempt to clear his airway.
On arrival, the resuscitation team noted that Master A was in profound bradycardia (slowing of the heartbeat), was not spontaneously ventilating and was deeply unconscious. In his deposition to the Coroner a doctor recalled :
"I found the pharynx flooded with black material which I attempted to suck out and despite my assistants providing cricoid pressure [pressure on the cartilage which forms part of the larynx], material continued to come up into the pharynx. Although I could see the epiglottis I couldn't see the vocal cords and I asked [the anaesthetist] to be called to assist."
The Charge Nurse recalled :
"I returned to the Resus Room to gain an overview of the situation. Dr [B], whose resuscitation role had been taken over by the anaesthetist and paediatrician, indicated that he needed to go and inform the parents of what was happening. I accompanied Dr [B] to see the parents and inform them of the gravity of the situation."
The anaesthetist was able to establish an airway by successful intubation. He found charcoal to be present within the trachea (windpipe). In his Coroner's deposition, the anaesthetist recalled :
"I immediately attempted to intubate the trachea. This was impossible as the laryngeopharynx was full of charcoal mixture and the anatomy was obscured. I suctioned the fluid but it continued to well up from the oesophagus (no doubt caused by the continued external cardiac massage). The cords were abducted (open) and the larynx was clearly soiled with charcoal."
He further recalled :
"I experienced extreme difficulty forcing air into the lungs. I introduced a suction catheter via the endotracheal tube [tube inserted into the windpipe] and aspirated charcoal mixture from the trachea. I then introduced the large bore nasogastric tube into the stomach and aspirated air and charcoal."
During the resuscitation attempt Dr B spoke to Mr and Mrs A, informed them that the situation was grave and stated he did not know what had gone wrong. Dr B then departed the hospital.
Following the resuscitation effort by the team of more than 40 minutes and given the fact that Master A was noted to be in a dying heart rhythm (i.e. broad complex bradycardia) the efforts were stopped and Master A was pronounced dead at 9.10am. At this point the nursing staff, who were in significant distress, were permitted by the charge nurse to go home.
Dr B, SN C and SN D returned to the Hospital later that day. SN C signed the notes he had taken that morning while Dr B and SN D completed their notes of the morning's events. The notes completed by Dr B and SN D were not annotated as being recorded after the event.
The Coroner held a Coroner's inquest on 3, 4 and 27 November 1998 releasing his report on 4 February 1999. The Coroner's conclusion was that :
"The short finding which is required to be made is that [Master A] who was born on 26 November 1995 and whose home was at [ ... ] died at [the Public] Hospital on 21 April 1998. The cause of his death was accidental aspiration of a charcoal solution into his trachea and lungs when such solution was being administered through a naso gastric tube at the Accident and Emergency Department at [the Public] Hospital to counteract suspected accidental Paracetamol poisoning which had occurred at home."
The Coroner in the body of his report also found :
23 "There is a delay (which will be referred to later) in Paracetamol levels in blood peaking. Taking into account that delay Ms [ ... ] [a forensic scientist who provided an analysis of Master A's blood after his death] conclusion was that while the concentration of Paracetamol in the blood of [Master A] was higher than was normally to be expected in a therapeutic dose it was not as high as would be expected in a fatal overdose. [The paediatrician/emergency physician expert witness at the Coroner's inquest] (whose evidence will be referred to later) was of the view that the dose which [Master A] had taken would have caused him no harm whatsoever."32 "The reality is that Doctor [B] in setting out to administer the charcoal solution by naso gastric tube was acting entirely in accordance with the then appropriate conventional practice. The then conventional belief was that the practice was reasonably safe. Given the uncertainty about the amount of Paracetamol consumed and given the then protocols, it was reasonable for Doctor [B] to proceed as he did."41 "I am satisfied that Doctor [B] did test the position of the terminal end of the tube by introducing air. I have reached this conclusion having regard to the evidence of Doctor [B] and Staff Nurses [C] and [D] each of whom said that this happened. Mr [A] also saw something which was consistent with this having happened in that he said that he saw the Doctor put his hand down to feel [Master A's] stomach and then make some reassuring comment. I am further satisfied that on the basis of what he heard Doctor [B] believed that the tube was correctly in position. The air expulsion method of determining the placement of the terminal end of the tube was in my view a reasonable test for Doctor [B] to use having regard to the then knowledge."50 "Having carefully considered all of the evidence, unsatisfactory although some of it is, I have reached the conclusion that it is more probable that the tube was correctly placed."51 "I therefore find, although it is not free from doubt, it is more probable that the charcoal solution which entered [Master A's] larynx and blocked his trachea had been delivered into his stomach, had left his stomach, had passed up his oesophagus and had then been drawn into his larynx, trachea and lungs."57 "It seems possible that the nature of the treatment itself, the horizontal position of [Master A] and the unnatural presence of a tube in his oesophagus and at the entry to his stomach could have been factors in the loss of stomach contents into his oesophagus and the draining of those stomach contents into his larynx."60 "It seems apparent that the various restraints to which [Master A] was subject had the effect of suppressing or disguising the physical reactions of [Master A] to having the charcoal solution enter his air passages. The evidence in its totality points to the aspiration having occurred during the treatment and not during the period in time when [Master A] had been handed back to and was being held by his father."
Advice obtained by Mr and Mrs A
Mr and Mrs A provided the Commissioner with a copy of advice they had obtained from a medically qualified lawyer. The medically qualified lawyer stated :
"' ... I guess if there was no procedure he would still be alive.' This statement of [Master A's] father at the inquest (p 11,4,5), referring to the insertion of a nasogastric tube and the instillation of activated charcoal via this tube, summarizes the precipitating event which led to the death of his child.We know that a nasogastric tube was inserted. We do not know what the passage of the tube was after it entered the nose; whether it entered the oesophagus or the trachea. This is a matter of speculation and all the theories of how charcoal came to enter the lungs are also the product of speculation. We know that, at autopsy, charcoal was found in the stomach and duodenum and in both lungs extending into the 'terminal bronchioles' and 'the peripheral and subpleural lung'. (Statement of [the] Pathologist, [ ... ].)The decision by Dr [B] to insert a nasogastric tube in order to instil activated charcoal was based solely on it being standard procedure according to guidelines at that time for the treatment of accidental ingestion of Paracetamol by children. It cannot be emphasised too strongly that the repeated assertion of reliance upon such guidelines and this procedure as 'standard' are the foundation upon which its justification is laid. In reply to this, the question that must be asked is : do guidelines protect a doctor against exercising a reasonable standard of care?Should the facts of each case not be considered on their merits? The disclaimer on the database of the NZ Poisons & Hazardous Chemical Information Centre states : ' ... each user should review the information in specific context of the intended application'. Although neither Dr [B] nor the nurses at [the Public] Hospital's emergency department contacted the Poisons Centre for the latest information at the time of [Master A's] admission, it nevertheless acts as a clear indication that guidelines alone are not considered to be sufficient reason to act upon them in the absence of consideration of the facts of each case.A medical student or house-surgeon, both only permitted to work under supervision of qualified medical practitioners, may be expected to follow protocol or guidelines without question. A qualified doctor is expected to use judgement and use protocols only as guidelines and not as gospel, to assess each case on its facts, to weigh risk and benefit, to withhold from doing something if doing nothing would be less likely to cause harm - primum non nocere. This is what may be reasonably expected to arise from the duty of care owed by a doctor to a patient.Do doctors' compliance with practice guidelines create an impenetrable shield against legal liability? If they follow recognised guidelines to the letter, does this excuse negligence?Does this excuse failure to reasonably foresee dangers and not act on this foresight or refrain from acting, if this be the appropriate course? Do these guidelines conspire to defeat the duty of care that contractually arises from a medical professional's offer to help and a patient's consent to this help? Are they to be seen as an acceptable defence against reasonableness of action? Do they replace or substitute for reasonable action? Do they, in fact, represent the standard of care reasonably required?'I guess I was driven by the way we treat paracetamol accidental poisoning from a variety of sources.' This statement by Dr [B] during the inquest (p 81, 8-10) illustrates my point that he was relying blindly and without question or professional critical appraisal on what he believed at the time to be the guidelines for treatment of this condition. What were the Poisons Centre guidelines at the time that Dr [B] and the nurses could have, indeed should reasonably have, accessed but did not? In the key section on 'Health Hazard Information' under 'Toxicity' it states : 'Estimates of the amount of paracetamol ingested are often unreliable, so that predictions of hepatotoxicity should be based on serum paracetamol concentrations'. It continues : 'Children appear to be less susceptible to hepatotoxic effects even with blood concentrations that would be potentially toxic in adults'. In its section headed 'Signs and Symptoms', it states that liver necrosis occurs in Stage III but that in Stage IV there are patients who recover with 'normalisation of liver function tests' and 'hepatic architecture returns to normal within 3 months'. It would be instructive to ask the Intensivists : what percentage die in Stage III? What percentage survive? Adults vs children? Of children who may have died in Stage III and had not been given charcoal, was there a causal link established between the absence of charcoal treatment and the ensuing liver necrosis and/or death? Of those who received charcoal and survived Stage III unscathed, was there a causal link established between this and their survival?The critical question is : did Dr [B] believe the situation was life-threatening and did he believe giving charcoal was life-saving? None of the counsels put this question explicitly. Dr [B], however, gives us a clue as to his thinking on this matter when he said at the inquest : ' ... If I really felt the risk of the charcoal was that much higher I wouldn't have done it' (p 81, 3-4). When a doctor believes a life-saving procedure is immediately required, then that procedure demands to be undertaken in the face of all other risks. Clearly, Dr [B] did not feel this was such a situation but was 'driven' to intervene by 'standard procedure'. In fact, he recalled that he might have told Mr & Mrs A 'that it is quite a common procedure in hospitals for giving charcoal like this ... ' (inquest p 80, 18-19). Significantly, he comments later that, had the complication not have intervened, he would've instructed the parents to take [Master A] home and bring him back 4 hours later for a paracetamol blood level and adds : 'Then we would [have] acted on the paracetamol blood level either way having given charcoal or not ... ' (p 81, 18-19). Importantly, he adds : 'The antidote being NAC' [N-Acetyl Cysteine].What does this tell us? That he did not believe charcoal was a life-saving treatment. He acknowledges that having given charcoal or not would've made no difference to waiting for the paracetamol blood level 4 hours post ingestion. He acknowledges that, according to the level on the 'graph' (Rumack-Matthew nomogram [ ... ]), he would've decided on use of the antidote, which he knew to be NAC. So, when [Master A] would not drink any more charcoal, why did Dr [B] not send him home with his parents, get him back 4 hours post ingestion, do the paracetamol blood level, read it off the graph, assess toxic or non-toxic level, assess the need for NAC? Despite acknowledging he knew 'there had been spillage' (p 105, 4) [evidence by [Master A's] parents was of spillage of paracetamol on the floor and desk when they found him], he stated, 'I wanted to get the charcoal in sooner rather than later ... ' because he was interested in 'getting on and getting [the] job done ... ' (p 105, 7-8). He did not wait to ascertain the paracetamol blood level, he did not hesitate to insert a nasogastric tube and instil charcoal because 'that would contradict the guidelines at the time' (p 105, 34). I must emphasise, however, that this was merely an assumption on his part (and that of the nurses) at the time because [the Public] Hospital did not have the current Poisons Centre CD-ROM, nor had he (or the nurses) made any effort to contact the Poisons Centre to acquire the current information. So, not only were they following guidelines blindly, they were following guidelines which they had not even bothered to ascertain were the current guidelines. Was this reasonable? I submit not.This brings me back to my earlier consideration of whether blindly following guidelines without reference to the facts of each case is sufficient to establish evidence of reasonable medical practice. If this is so, then critical thought and analysis of each set of facts and each situation is redundant and common sense may be dispensed with. If this is so, then doctors are bound to act only according to didactic training and, while acting within these bounds, are safe from legal challenge. If this is so, then there is no reasonable basis to proceed with an action in this case. I believe, however, that if the medical experts who gave evidence at the inquest had been asked whether they act blindly on guidelines or recommend their trainees to do likewise, there answer would have been in the negative. Certainly, had they been asked whether they act on guidelines before having ascertained whether these are current, they would've answered in the negative. Had they been asked the same questions about Dr [B's] behaviour, they would have been bound to answer in the negative. They would have answered that it was not reasonable medical practice.Dr [B] himself stated during the inquest, firstly, ' ... there is giving charcoal and putting a nasogastric tube in. Charcoal itself is harmless unless it finds its way in the wrong place thru [sic] whatever means' (p 109, 30-32). Charcoal had been given. [Master A] had drunk an unknown volume of this charcoal. This volume had been considered by Dr [B] to have been inadequate. At this stage, [Master A] was well. At this point, 'driven' by the guidelines and eager to be 'getting [the] job done', Dr [B] proceeded to insert a nasogastric tube. From this act and, in fact, from the decision to proceed with this act, all the complications leading to the death of [Master A] flowed. Patients may reasonably expect a doctor not to act blindly but to apply his mind to each case. Dr [B] did not do this, even though he admitted at the inquest : 'every child is slightly different; no two children the same.' (p 133, 3). He misled [Master A's] parents into believing that the insertion of a nasogastric tube in this case was vital and indispensible to saving [Master A's] life or, at least, preventing serious liver damage; consequences which might not have any causal link with giving or withholding charcoal (see questions above). He did not inform them of the life-threatening complication of charcoal entering the lungs (by aspiration or directly). He led them to believe the nasogastric tube insertion was 'routine', which it is generally but not in such a case where the purpose is to instil charcoal. He failed, therefore, to allow them a reasonable opportunity to weigh the risks against the benefits. Consequently, he cannot reasonably be said to have obtained informed consent.The insertion of the nasogastric tube and the instillation of charcoal :Having inserted the nasogastric tube, Dr [B] would have reasonably been expected to check that it terminated in [Master A's] stomach. What did he do? We know from the evidence that he attempted to aspirate fluid in order to test it with litmus paper. If the litmus paper changed colour to indicate acidity, that would indicate that the fluid was most likely to have originated from the stomach, gastric fluid being known to be acidic. Did he succeed in aspirating fluid? No. As a result, he was not able to test for acidity. Therefore, he was bound to discard this test as a failed test. The arguments by counsels to ascertain the precise length of tube introduced are irrelevant and based, I submit, on their unfamiliarity with clinical phenomena. It is not uncommon for nasogastric tubes to curl back on themselves during insertion when this is not done under direct vision. Most often this is seen in the mouth. Given the soft narrow nature of the tube inserted into [Master A] and the fact that nothing was aspirated following insertion, it is not unreasonable to postulate that the tube might have curled back on itself at some point, whether in the oesophagus, trachea or one of the main bronchi. As a result, whatever occurred, arguments based on the length of tube inserted cannot confirm whether the distal end of the tube came to rest.What did he do next? According to his evidence, he used a 60ml syringe to inject air down the nasogastric tube for the purpose of insufflating air into [Master A's] stomach while he listened over the stomach with a stethoscope to confirm that the air he was injecting was, in fact, passing into the stomach, thus confirming the presence of the terminal end of the tube to be in the stomach. Was this test successful? We know from his evidence as well as that of the nurse assisting him and [Master A's] parents that Dr [B] used one hand to inject the air down the tube. We do not know what type of connection the syringe had or whether it fitted the proximal end of the tube snuggly and airtight or whether Dr [B] had achieved an airtight fit between the syringe and the tube. Why is this important? Because if there was not an airtight fit, then air would've escaped between the syringe and tube. Depending on the presence of a leak, only some or none of the air injected would've reached the stomach, if the tube was in the stomach. This would've reduced the possibility of hearing air injected into the stomach or made it impossible. Either way, it would've rendered this test inadequate or useless.These points were not raised at the inquest. It would be instructive to ask an Anaesthetist or Intensivist whether all 60ml syringes make an airtight fit with a size 10 french nasogastric tube, whether a person with reasonable dexterity could effect an airtight fit using only one hand and whether an airtight fit is a prerequisite for performing this test to a reasonably adequate standard. Would the lack of an airtight fit lead them to reject the result of this test?How did Dr [B] listen for air entering the stomach? With a stethoscope over the upper abdomen, we are told, though there is no clear evidence of this except Dr [B's] assurance of his tactile identification of the correct anatomical area. Did Dr [B] use an adult or paediatric stethoscope and which side of the bell did he use? These would each provide different nuances on ausculation as regards sound reception. It would be instructive to ask an Anaesthetist or Intensivist whether such differences might be significant.Did Dr [B] place the bell of his stethoscope against the skin of [Master A's] epigastrium? He says he did but no-one else present could confirm this. All that is agreed is that his hand was seen to go under the cuddly. Why is it important to know that the bell of the stethoscope was in contact with the skin of the epigastrium? We know that Dr [B] did not undress [Master A] and that [Master A] had 3 layers of clothes covering his torso. On top of this was the cuddly, tightly wrapped. There is no evidence to corroborate Dr [B's] assertion that his stethoscope's bell was against [Master A's] skin. The diaphragm of a stethoscope is designed to be used against the skin. Any intervening material reduces the clarity of sound reception and procedures extraneous sound. At best, if the stethoscope bell was against the skin, ausculation of the insufflation of air would've been interfered with by the movement of 3 layers of clothing and the cuddly against one another and the innermost layer against the skin and the stethoscope (bearing in mind that [Master A] was struggling against his restrainers).Then there is the question of the contribution the congenital heart defect, patent ductus arteriosus (PDA), might have made to the sounds Dr [B] heard. The PDA was dealt with perfunctorily at the inquest, only being cited and accepted as having made no contribution to [Master A's] death. No-one questioned whether the PDA produced a 'murmur' and, if so, whether such murmur might have impinged on Dr [B's] ausculation of [Master A's] epigastrium. Dr [B], though he said he was aware of the PDA, never examined [Master A]. Therefore, he would not have known whether a murmur existed or not and, if it did, what its nature was, especially how loud it might have been. It is well known in little children of [Master A's] age that chest and upper airway sounds are easily transmitted and may be clinically confusing when ausculation is undertaken, sometimes being mistaken for abnormal sounds. The PDA commonly, though not invariably, produces a 'machinery-like' sound over the precordial area of the chest. I submit that it is quite possible that, if there was a murmur, it might have been transmitted to the close proximity of the adjacent epigastrium. In the presence of the other interfering sounds mentioned above, it is not unreasonable that it might have contributed to confusing Dr [B] to mistakenly interpret the sound he claims he heard as that of the insufflated air. It will be useful to get the opinion of a Paediatric Cardiologist on this matter ... .How useful is the air insufflation test in determining the correct placement of a nasogastric tube? It is one of the tests routinely used for this purpose but is not regarded as a definitive test. In fact, as [the paediatrician/emergency physician expert witness at the Coroner's inquest] said, it is the least reliable of all the tests. An argument was made that this test is used routinely, nevertheless, for determining the placement of a nasogastric tube in operating theatres. We must be careful to distinguish its use in these circumstances from its use as a conduit for the instillation of charcoal. In theatre, firstly, it is inserted by Anaesthetists, specialist or registrar, for whom it is an almost daily procedure; secondly, it is inserted into an immobile patient under general anaesthesia, often paralysed by muscle relaxants, i.e. ideal condition; thirdly, the patient is mostly already intubated with an endotracheal tube, thus leaving the oesophagus as the only unoccupied aperture in the throat; fourthly, and perhaps most importantly, the nasogastric tube is inserted to serve as an outlet from the stomach to facilitate decompression or the aspiration of gastric contents by the Anaesthetist. It is not inserted for the purpose of instilling fluid, especially not charcoal, which, if the tube was misplaced in the trachea instead of the oesophagus, could lead to this fluid entering the lungs, thus leading to chemical pneumonitis or death. Furthermore, the tube is not infrequently inserted under direct vision, i.e. with the benefit of direct laryngoscopy.In the circumstances, I submit that there was no reasonable basis for Dr [B] to have believed that this test had confirmed the placement of the tube in the stomach. The standard of care expected from Dr [B] was higher than that which would have been expected from him in theatre circumstances, for the following reasons. Even if we concede that the insertion of a nasogastric tube is a routine procedure, the instillation of charcoal down the tube demands a standard of care commensurate with the foreseeable complication of charcoal entering the lungs via a misplaced tube with the foreseeable result of that complication being death. This should be the same as the standard of care required when intubating someone with an endotracheal tube : 'when in doubt, pull out', is the maxim used by Anaesthetists, especially to those in training. The reason is obvious : if one is not completely sure that the tube is in the trachea, pull it out and repeat the procedure. If this is not done and the tube has inadvertently been placed in the oesophagus, the patient will become hypoxic and die. So too when inserting a nasogastric tube for the purpose of instilling charcoal. If not completely sure the tube is not in the trachea, the only reasonable course of action is to pull it out before instilling the charcoal and reinsert it. [The paediatrician/emergency physician expert witness at the Coroner's inquest] makes this clear twice, in his statement and at the inquest.Further questions might be asked :If he was not sure, why were small test doses of, eg. sterile water/saline not first instilled down the tube?Why were the available specialists not called to assist when he was not sure? They took only 10min to get to the hospital when summoned to resus and Dr [B] admitted there was no rush.Why did he not get an Xray to confirm the position of the tube? Much was made of the reluctance to expose the child to Xray and the time factor. Firstly, we know no rush was required. Besides, in a small hospital during normal working hours, it would have been a quick and easy matter to obtain an Xray. Secondly, only one plain Xray - which in [Master A's] case would've fitted both chest and abdomen on one cassette - was all that was required. It is far-fetched to suggest that is potentially harmful, besides the fact that this type of Xray causes minimal exposure effects. It would be instructive to get the opinion of a Radiologist on this matter. Most important, however, should have been the consideration that the minimal risk of the Xray was far outweighed by the benefit accruing from its result, which may have enabled the avoidance of a life-threatening complication.[The paediatrician/emergency physician expert witness at the Coroner's inquest], in his statement, described the complication of charcoal aspiration as 'very rare' (p 7). This indicates it occurs very infrequently but does not imply that it is a trivial complication. He does not indicate whether this complication arises from aspiration or direct instillation via a nasogastric tube into the trachea but one may assume that this possibility is covered. While the frequency with which it occurs may be 'very rare', its seriousness demands that it be regarded as a reasonably foreseeable complication. When faced with the foreseeable complication of death, the only acceptable standard of care is that which requires all reasonable precautions to be taken in order to be completely sure, to have no doubt, that this complication is avoided. In this case, 100% certainty is the only sufficient condition that will satisfy reasonableness and the duty of care owed the patient. Anything less fails the duty of care and, therefore, must be regarded as negligent. Dr [B] failed to meet this standard and, therefore, must be regarded as having acted negligently.The question of how the charcoal came to enter [Master A's] lungs is, as I said, a matter of speculation but, on a balance of probability, the pattern of careless and negligent behaviour exhibited by Dr [B] establishes a presumption that the entry of charcoal into [Master A's] lungs, causing his death, resulted from a failure by Dr [B] to exercise a reasonable duty of care towards [Master A].I shall, nevertheless, address the speculation surrounding the entry of charcoal into [Master A's] lungs.We know the following :[Master A] swallowed from a cup either '2 x mouthful' of charcoal (Dr [B's] hospital notes) or '4 big gulps' of charcoal (Mr [A's] statement, p 6) prior to insertion of the nasogastric tube. There were no observed ill-effects. From this we may infer that he had no pre-existing neural or mechanical defects interfering with normal swallowing.[Master A] was observed to have stopped making sounds after insertion of the nasogastric tube. This may be important for the support of the theory that the nasogastric tube was inserted down the trachea, i.e. that it passed between the vocal cords. From an anaesthetic point of view, I know that patients who awaken with an endotracheal tube still in place often struggle and produce blowing sounds through the tube but nothing louder or more specific than this. The same may be true of an awake patient with a nasogastric tube between the vocal cords, albeit in this case a narrow tube. In my opinion, this might provide the most logical and probable explanation for the reported disappearance of sounds following the insertion of the NG tube. Blowing sounds, if they were present, might have been easily obscured in a small struggling child with those restraining him. I suggest that you seek clarification on this point from a Speech Therapist who has experience with rehabilitation of patients in ICU's. A Paediatric Anaesthetist or Intensivist might also be of assistance ... .After insertion of the nasogastric tube, Dr [B] instilled 120ml charcoal via the tube in approx 30sec (rate of approx 4ml/sec) by means of two 60ml syringes. [Master A] was restrained in the supine position during the instillation of charcoal; a patient having fluid instilled via a nasogastric tube is ideally and invariably placed in the left lateral or decubitus position prior to instillation. There are 3 reasons for this :
1) the most important reason is to prevent aspiration in the event of vomiting or regurgitation;2) it assists the flow into the stomach in the optimal anatomical direction;3) having regard to the design of a laryngoscope, it facilitates intubation with an endotracheal tube should the need arise.
Aspiration of charcoal was one of the theories advanced for the presence of charcoal in [Master A's] lungs. As I have stated above, this was a complication that Dr [B] should reasonably have foreseen. By having [Master A] in the supine position throughout the instillation of charcoal via the nasogastric tube, Dr [B] failed to fulfill his duty of care to [Master A]. If aspiration was the cause of charcoal entering [Master A's] lungs leading to his death, then Dr [B] must be held to have been negligent.On the other hand, the other possibility is that charcoal entered the lungs directly via a nasogastric tube inserted into the trachea. The autopsy finding was that 50ml of charcoal were found in the stomach and duodenum (autopsy notes, p 4). The Pathologist stated that he was unaware at the time of autopsy that [Master A] had drunk some charcoal prior to the insertion of the nasogastric tube. As a result, his finding of aspiration being the cause of charcoal having entered the lungs was based on ignorance of this fact. Undoubtedly, this coloured his finding. He skirted this issue (was allowed to skirt this issue) at the inquest, claiming it would not have changed his finding as the volume of charcoal found in the stomach and the duodenum was, by volume, greater than that which had been ingested orally. Was he justified to be confident of this claim? There is no evidence that he analysed the 50ml of charcoal to establish whether it was pure, unadulterated charcoal or contained other substances, eg. gastric fluid. No-one knows what total volume of charcoal [Master A] swallowed prior to insertion of the nasogastric tube. We know, however, that Dr [B] instilled a total of 120ml of charcoal via the tube. So, where did the remaining 70ml go? The only possibility is the lungs, as the evidence is that [Master A] did not vomit. Therefore, even if we accept that the 50ml found in the stomach and duodenum was pure charcoal, then by volume, approx 58% entered the lungs and only approx 41% entered the stomach and duodenum. If, however, we take into account that part of the 50ml in the stomach and duodenum was from the unknown volume orally ingested, then it is clear that an even greater volume and percentage must have found its way into the lungs. So, using the Pathologist's own reasoning, it seems possible that this greater volume entered the lungs directly via a nasogastric tube inserted in the trachea.If the nasogastric tube had been inserted in the oesophagus, could 70ml or more of charcoal been aspirated? We know that [Master A] was fully conscious at the time of instillation of the charcoal. We know his swallowing was normal. This means his laryngeal reflex was intact. This is the involuntary mechanism that acts to protect the airway, i.e. the glottis from penetration by solids or fluids. It is probably the strongest protective reflex in the body's armamentarium. It may be compromised in a person with a depressed level of consciousness. It is possible that it may be breached in a person in the supine position with an overwhelming presence of fluid in the mouth and pharynx, restrained with no possibility of turning on to the side or sitting up and with these restraints causing significant alterations in the dynamics of dead space, lung compliance, intrapleural pressure and oesophageal pressure. It would be instructive to get an opinion from a Respiratory Physician about these dynamics and how they might have influenced or promoted aspiration, if indeed it occurred. ... It might also be useful to ask the Paediatric Cardiologist I recommended about the effects these dynamics might have had on the PDA.It must be emphasised, however, that it would take only a miniscule volume of fluid to provoke a paroxysmal cough in a desperate effort to expel even such a volume. [Master A] was a 14kg child, fully dressed, wrapped tightly in a cuddly and restrained in the supine position by 3 adults. Despite this, we know he was still struggling. It is not unreasonable to submit that, if he had aspirated a small volume of charcoal, his reaction to it might, in the circumstances, have gone unnoticed. It is, however, equally unreasonable to postulate that, during a 30sec period in which 120ml of charcoal was instilled via the NG tube and, assuming for the moment that the tube was in the stomach, he would've aspirated a minimum of 70ml of charcoal. Laryngospasm would have supervened at a far earlier stage. The rate of regurgitation of such a large volume within such a short space of time in a 14kg child would reasonably predict the mouth filling rapidly with charcoal, some of which would probably have spilt from the mouth and nose. The evidence does not mention this; nor does it mention it when he was handed to his father or taken to resus. The first time we hear of free charcoal being seen is when [ ... ], the Anaesthetist, mentions in his statement that 'the laryngopharynx was full of charcoal mixture ... ' (p 2). This was some 10min after the charcoal had been instilled via the nasogastric tube.It would appear that the most likely cause for a large volume of charcoal to have entered the lungs was direct instillation via a nasogastric tube placed in the trachea. This occurred as a result of Dr [B's] failure to take reasonable precautions to ensure the tube was in the oesophagus and not the trachea, as I outlined above. Dr [B] should have reasonably foreseen this complication which led to the death of [Master A]. By not doing so, he failed in his duty of care and, therefore, acted negligently."
Independent Advice to Commissioner
The Commissioner sought advice from an independent emergency medicine specialist who responded to the Commissioner's questions as follows :
Was the decision to administer the charcoal solution and to use a naso gastric tube appropriate?"In April 1998, the protocol used by Emergency Departments around New Zealand and internationally promoted by Poisons Centres, indicated the need for gastric decontamination using activated charcoal for potentially toxic ingestions of Paracetamol. As mentioned, current recognised authorities [as written in textbooks of Emergency Medicine and Toxicology] concurred with this approach.The dosage of activated charcoal recommended for children was 1-2 mg/kg of activated charcoal following a paracetamol overdose involving ingestions in the toxic range [ie. > 200mg/kg].Additionally, the norm required the clinical staff to assume that the child had ingested the maximum possible [the amount missing from the bottle] even though spillage may have been obvious by the parents/caregivers.Therefore, when the nursing and medical staff of [the Public] Hospital ED were told that [Mr and Mrs A] had a 500ml bottle of Pamol with a concentration of 250 mg/5ml and that 125ml was lost from the bottle, they were required, under the protocol, to assume that all of this was ingested by [Master A].As [Master A] weighed 14kg this equated to a potential ingestion of 6250mg / 14 = 446 mg/kg. This was greatly in excess of the recommended potential 'toxic level' and as such indicated some degree of urgency to the staff to proceed immediately with gastric decontamination according to the protocol.In undertaking this approach, they considered both the size and recentness of the ingestion. [Master A's] ingestion of the Pamol had occurred most likely within 1 hour of his presentation to the ED, which was within the guidelines for this manoeuvre.Textbooks of Emergency Medicine and the Poison Centres further advise that if the charcoal cannot be ingested orally, the recommendation 'should/may' be for the placement of a naso gastric tube through which the charcoal can be instilled directly into the stomach.As indicated in the expert opinions obtained for the Coroner's inquest, many Emergency Physicians, both here and overseas (as well as the authors of textbooks such as Rosens) have questioned the invasiveness, the success, the evidence, and the risks associated with this recommendation.In New Zealand, as mentioned, with the publication of the '[a children's hospital]' paper, the proposed major changes in the protocol from a Paediatric Accidental Ingestion of Paracetamol Elixir could be :
An 'upping' of the level at which the antidote would be used (that is, instead of using >125mg/kg it is recommended that > 225mg/kg would be appropriate);The time for obtaining the serum paracetamol level would be changed from 4-hours to 2-hours;Discouraging/discontinuing the use of gastric decontamination with activated charcoal if more that 30 minutes had elapsed post ingestion. This is due to its lack of effectiveness in this population because of rapid absorption of the paracetamol elixir, as well as a lack of evidence overall for the effectiveness of this strategy as well as the availability of an effective and safe antidote."
Should Dr B have advised Mr and Mrs A that there was risk associated with this procedure?'Doctors and nurses are required ... to inform patients/caregivers of the benefits and the harms associated with particular treatments and/or procedures.Generally, this information is meant to include 'likely' benefits and harms.Dr [B], in his affidavit indicates that he did not discuss the reasons, the benefits or the potential harms associated with the use of either activated charcoal or the procedure of naso gastric intubation and charcoal instillation, with [Mr and Mrs A].Neither did he discuss the harms and potential management of a childhood accidental paracetamol poisoning with them.Often in Emergency situations, where time is at a premium, detailed informed consent of this magnitude is difficult, if not impossible, to undertake.There is a waiver in the Ministry of Health's Informed Consent Guidelines for Emergency situations where life or death may be imminent. However, it is difficult, in [Master A's] situation to justify such immediacy under this banner.It is known that clinical staff working in Emergency Departments often take a literal approach to treatment or management protocols, particularly when the dose thought to have been ingested is in the high toxic range. In [Master A's] case, urgency is definitely implied when the protocol is applied.It is also a well-known fact that health professionals often make decisions for patients/caregivers when providing therapeutic or diagnostic requirements for management of conditions.Often this is without involving the patients/caregivers in an informed discussion even though the patients/caregivers are most affected by these decisions. Clinicians often tell the patient what we plan to do/are doing, but frequently do not request consent to do so, often taking acquiescence as an acknowledgement by the patient/family that it is okay to proceed. There exists a body of medico-legal literature around the nature of this 'implied consent'. However, the issue has to do with 'informed' consent which is a different matter.With regard to the issue of advising [Mr and Mrs A] of the potential hazards related to the nasogastric tube insertion and the possible aspiration of charcoal into the lungs of [Master A] becomes a matter of probability. All medical professionals working in Emergency Departments are aware of the possibility of aspiration of charcoal subsequent to nasogastric instillation of the formulation. This complication is described in the literature - but couched under terms of significant rarity. Many doctors and nurses have performed this manoeuvre frequently in their careers with this complication never arising. It is likely that as a consequence, the knowledge of the possibility of aspiration occurring is subconscious and therefore often not considered. Dr [B] confirmed this as the case from his perspective in his report.As well, a prudent health professional takes as many steps as possible not to further increase the anxiety of parents who are already anxious. In this situation, the [A family] were not particularly anxious however, once informed that their son could die from the poisoning or might, in a very rare situation, suffer harm or die from the treatment, it is possible that they might have become anxious. The fact that Mr A had to move away from [Master A] during the insertion of the naso gastric tube as it 'distressed' him partially confirms this. However, raising a parent's anxiety level should not be seen as excusing the lack of information provided in such cases. However, a body of clinicians, undertaking this treatment, would have been unlikely to comment on the possibility of death by aspiration of the charcoal.The answer to this point, is that [Dr B] should have advised [Mr and Mrs A] of the potential risks of the paracetamol ingestion, the available methods of managing the ingestion including charcoal gut decontamination, the risks associated with this strategy and the options available.It is important to stress at this point, that Dr [B] did not conduct his own targeted history or physical examination of [Master A]. That is, he did not undertake a targeted medical review of [Master A] prior to undertaking therapeutic management of the problem. Such an approach is occasionally justified in patients requiring critical rescue. However in this instance, there was adequate time for Dr [B] to perform his own examination.Not doing his own examination precluded him informing the [A family] of the risks and benefits of both the intoxication as well as the management of the intoxication."Was the correct amount of charcoal administered given the age and weight of Master A?"[Master A] was weighed and the charcoal mixed according to the recommended guidelines provided both in the [Public] Hospital policy but also in the National Poisons Centre Policy.