Pediatric Sedation Newsletter August September

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Pediatric Sedation Newsletter August September Powered By Docstoc
					 Pediatric Sedation Newsletter – August-September
                       2002
Departments of Anesthesiology and Pediatrics, Children’s Hospital at Dartmouth,
Dartmouth Hitchcock Medical Center, Lebanon, NH
Editors: Joseph Cravero MD (joseph.cravero@hitchcock.org),
George Blike MD george.blike@hitchcock.org
Website = http://an.hitchcock.org/PediSedation/
Circulation 3045

Invitation:
    Rather than print an editorial this month, we would like to invite those who read this
newsletter to consider participation in a collaborative group investigating pediatric
sedation practice. I think all of us involved in the practice of pediatric sedation would
agree that there is preciously little helpful information available on the safety and
efficacy of pediatric sedation practices. While many individuals are pursuing very good
work on several aspects of pediatric sedation practice, we rarely see studies with the
power to inform us of the true nature of current sedation practice – especially when we
consider relatively rare events like sedation related injury.

   We would like to propose a Pediatric Sedation Research Consortium (PSRC). This
consortium would be designed to allow a variety of institutions to share information on
methods and outcomes of pediatric sedation. We propose the development of database
comprised of thousands of pediatric sedation encounters. Similar groups have been
formed to look at many other fields of medical practice (i.e. cardiac surgery) and have
provided a huge amount of new information for its members and yielded hundreds of
abstracts and peer-reviewed reports.

   The PSRC would be organized with the following principles:

   1. All participants should be considered equal partners. Any publications or reports
      generated through the data compiled by the group would be cited as having come
      from the entire group.
   2. The group would ideally meet in person once before starting the collection of data
      and once a year thereafter – all other business will be conducted over electronic
      communication.
   3. The first meeting of the group would be focused on developing a one page
      reporting document that would be completed for each sedation. The information
      on this “data sheet” would include patient demographic data, procedure,
      medications employed, techniques used, basic outcome data etc. The key
      elements of this data sheet would include simplicity and collection of the most
      important information relating to a given sedation.
   4. The information collected from the data sheets would be compiled and kept in a
      database that would be maintained at Dartmouth Hitchcock Medical Center – this
      data would be available at all times to any investigator who would like to evaluate
      the data.
   5. At periodic intervals, members of the consortium would visit other sites or
      institutions involved in the consortium. These “site visits” have proven extremely
      informative in other study groups such as this – allowing institutions to benefit
      from seeing how different providers attack similar problems.
   6. IMPORTANT: Participation in this group would in no way preclude any
      participant from continuing their current sedation research projects.
   7. Grant money would be sought to support the operation of this consortium. Any
      funding that is obtained would be fully shared among the group in order to
      support its ongoing operation.

   Please consider participation in this project. We would ask each institution to identify
one individual who would be primarily responsible for coordinating the efforts of the
consortium in your institution. This individual might most optimally be a physician,
however any appropriate sedation provider would be welcomed.

   We feel strongly that this group could significantly improve the data that is currently
available on pediatric sedation practice. Participation should allow individuals to be at the
forefront of pediatric sedation research and will doubtless produce fertile data for
academic pursuits. Most importantly we feel sure that the information derived from this
group will ultimately yield improvement in the safety and efficacy of pediatric sedation
and in this way benefit children in the long-term.

Thanks for considering this opportunity.


Literature Reviews:
   We will look at two studies involving the drug etomidate for this issue. Etomidate is
R (+) ethyl-1- (1-phenylethyl) –1H imidazole 5 carboxylate. The drug is a powerful
sedative hypnotic that has been used in anesthesia, emergency medicine and critical care
for many years. It produces sedation without analgesia. The primary advantage of the
drug over other commonly used sedatives is the fact that is causes little disturbance of the
cardiovascular system. It is used primarily as a sedative hypnotic for rapid sequence
induction and intubation– particularly in patients where it is feared that our usual
sedatives might cause profound hypotension. Over the last several years etomidate has
been used as a sedative for procedures - most commonly in the emergency department.
Etomidate causes relatively little respiratory depression when as a sole agent however
loss of airway reflexes is very possible depending on the dose and patient factors such as
age. Common side effects associate with etomidate include nausea, vomiting, and
myoclonus. Adrenal suppression has been well described although the clinical
importance of this phenomenon after one dose given for intubation or brief sedation is
minimal.

Etomidate’s widest application has been in adult trauma patients and others with fragile
cardiovascular profiles. Its use in children has been limited, and it would seem to offer
few advantages over other available medications with similar sedative properties and
fewer side effects for children. In spite of this, etomidate appears to be growing in
popularity as a sedative agent and we thought it would be interesting to review a couple
of the more recently published studies involving its use as a sedative.

Etomidate for procedural sedation in the emergency department. Samuel Kiem et al.
Pharmacotherapy 22(5):586-592,2002

Abstract of the Article:

The authors wished to examine their experience with etomidate in nonintubated patients
in the emergency room. The study consisted of a two-year retrospective review of
consecutive patients receiving etomidate for sedation in the emergency department of a
university based teaching hospital. A total of 48 patients were involved in the review.
The patients were predominantly adults but two children were included in the review.
Etomidate was given as a 0.1mg/kg bolus over one minute – the administration of other
sedative or analgesic medications was not controlled by the clinical use protocol
employed at this institution. Adverse events were reported in 11 of the patients (21%).
Adverse events were defined as apnea for greater than 30 seconds, oxygen saturation
below 90%, requirement for bag-valve-mask ventilation, emesis, aspiration, hypotension,
myoclonus, inadequate sedation, unsuccessful procedure, and cardiac arrest.
Of the charts reviewed in this study, two patients had emesis – one while sedated, the
other while recovering. No aspiration symptoms or signs were reported. Among the other
adverse events, one patient required bag-valve-mask ventilation because of apnea, and
one patient required a non-rebreather oxygen mask because of hypoxia. Both of these
patients received opiates prior to their etomidate. Of the other patients, 8% of procedures
were unsuccessful using this sedation protocol – including three hip dislocations. One
TMJ relocation was unsuccessful with etomidate but was later relocated under
fentanyl/versed sedation. None of the reported complications were severe as indicated by
the fact that none of the patients required hospital admission, prolonged emergency
department stay, or intubation.
The authors conclude that although the use of etomidate remains controversial, it holds
promise as a potent sedative agent for patients undergoing painful procedures in the
emergency department. They advocate a large prospective trial to document the
performance and complications of its use.



Commentary:

This retrospective chart review begins with a brief review of the different drugs used for
deep sedation in the emergency department. The authors recognize the limitations of their
study and their conclusions prominently feature the idea that further (and better) studies
involving this drug are needed – we agree.
 Although only two children were involved in this study, we wanted to review it since
etomidate use is not often described in sedation papers. We would like to comment on a
few areas of concern:
1. The authors describe their institutional sedation protocol that dictates NPO standards
   (8 hours) prior to using etomidate for sedation. On the other hand they note that the
   two individuals that vomited during the study period had eaten within two hours prior
   to the sedation! While we agree that reports of serious aspiration injury in the ED are
   not available, that does not mean it has never happened. Furthermore, as the agents
   used for sedation in the ED change, we are not convinced that this patient population
   will remain immune from aspiration injury. In addition, many of the problems with
   emesis after etomidate occur several hours after sedation -–it would be interesting to
   know the nausea and vomiting status of patients in the 24 hours after sedation, not
   just how they did until discharge from the ED.
2. The dose of etomidate described in this investigation (especially when combined with
   other medications) would meet the definition of “anesthesia” in many cases. The
   protocol in this institution included pulse oximetry and EKG monitoring. We would
   suggest end tidal CO2 monitoring would be an appropriate additional monitor for this
   level of sedation.
3. Although no serious injuries occurred, in light of the fact that two patients in a very
   small cohort experienced significant respiratory events, we would be concerned that
   this drug should only be used by individuals with excellent airway management
   skills.
4. The pediatric patients involved in this protocol were 6 and 9 years old. They
   apparently did fine. Still, we are concerned about the employment of essentially adult
   protocols for sedation use that are applied to children when a given provider feels it is
   appropriate. As the airway equipment, skills, and monitoring required are
   significantly different for children, we would like to have read that pediatric
   considerations were included.



Etomidate for pediatric sedation prior to fracture reduction. Dickinson R. de Sousa
SL. Lieb WR. Franks NP, Academic Emergency Medicine. 8(1):74-7, 2001 Jan


Abstract of the article:

   The authors begin with the idea that while etomidate has been reported as a procedural
sedative in adults, its use in children has not been extensively reported. This study
describes their experience with etomidate for procedural sedation in children with
extremity fractures and major joint dislocations.
   The study was a retrospective descriptive chart review. The setting was a university-
based emergency department (ED) that follows national guidelines for procedural
sedation. Subjects were children less than 18 years old who received etomidate prior to
fracture reduction or major joint dislocations. Standardized data were abstracted from the
medical records, including patient demographics, diagnosis, weight, types and doses of
sedative and analgesic agents used, number of boluses of etomidate, attempts at
reduction, complications encountered, vitals signs before, during, and after the reduction,
disposition, and the time from procedure to discharge.
   Fifty-three children received etomidate for fracture reduction. Their mean age was 9.7;
41.5% were females. Indications for reduction included forearm fractures (38), ankle
fractures (12), upper arm fractures (2), and hip dislocations (1). In most cases (83%)
reduction was successful after one attempt only. The mean, initial and total doses of
etomidate were 0.20 mg/kg (range, 0.1 to 0.4) and 0.24 mg/kg (range, 0.13 to 0.52),
respectively. Thirteen patients required a second bolus of etomidate or midazolam.
Thirty-four patients (64%) were discharged from the ED after a mean observation of 94
minutes (range, 35 to 255). There were no major adverse events (95% CI = 0% to 5.7%).
One patient reported nausea and one required a fluid bolus for hypotension. One patient,
receiving multiple sedatives and opioid analgesics, was admitted for observation due to
prolonged sedation. No patient required assisted ventilation or intubation. The authors
conclude that their results suggest that etomidate is a safe and effective agent for
procedural sedation in children requiring fracture and major joint reductions.

Commentary:

As always we object to the idea that a retrospective chart review of 53 patients leads to
the conclusion that this drug is “safe and effective” for pediatric procedural sedation in
children. Many of our concerns regarding the Kiem study hold for this investigation as
well. If emergency medicine providers would like to expand the use of this drug we
clearly need prospective data with reasonable power that could allow us to compare the
safety and effectiveness of this agent with others that are used for the same purposes in
the same settings.

Close Call and Critical Incident Reports
We invite those receiving the newsletter to submit cases to this "Close Calls" section
aimed at the key safety issues associated with providing pediatric procedural sedation.
The cases have been "sanitized" such that the date, patient identifiers, institutional
identifiers, provider information, etc. will not violate the privacy of the patient or care
providers.

Case #11
A 5yo girl with a new onset seizure requires EEG evaluation. The parents are instructed
to “sleep deprive” the child the night before the scheduled test. The neurologist informs
the parents and child that the test does not hurt and that giving sedation interferes with the
results. The parents successfully keep the child awake the night before the test. However,
while the mother is driving to the hospital (a 45min drive) she cannot keep her daughter
awake, and she sleeps in the back seat of the car.

During placement of the EEG (marking locations with a pen, using a solvent to clean the
skin and gluing the contacts in place) electrodes, the child is upset and requires physical
restraint. The technician states to the mother that the child is just “overly tired” and will
be OK, this is how most children are for this test. Lead placement takes 30min. Then
attempts are made to have the child settle down watching a movie, comforting by the
mother, etc. to no avail. About 2hrs into the test the neurologist is called and a decision is
made to give the girl oral chloral hydrate. The child takes some of the medicine, spitting
the rest out. About 20min later the child falls asleep and the EEG study is completed and
considered interpretable. The study is negative.

A follow up visit to the hospital and neurologist is associated with crying and fear
requiring the mother to carry the child. The mother states that while she understands that
the test needed to be done, she was not prepared and further, she did not prepare her
daughter for what was required.



Comments: As with the last newsletter, this case is not typical of the most of the close
calls we have reviewed in this newsletter. This case highlights a child that requires a test
in which sedative medications are “contra-indicated”. When considering procedural
sedation, one must consider the goals of the study and how sedative approaches might
impact the interpretability of the results. In this case, sedative medications act on the CNS
and clearly can affect EEG signals. Another interesting dimension of this case is that
since many institutions use chloral hydrate routinely, one might call this an under-use
error of sedation.

The aspects of this case to be reviewed: 1) Parent and child preparation; 2) normal and
abnormal sleep states; and 3) the impact of sedative technique on the test
result/interpretability. In addition, we will describe a strategy we have used recently on
three pediatric EEG studies performed at the Children’s Hospital at Dartmouth.

1) Parent and child preparation: All of us have limited time to prep children and families
for procedures. While it is
easy to criticize the           Demands                  Monitored Process
                                                                  Demands
clinicians involved, the
reality is that                                                Errors and Expertise

                                                                                         Sharp-end
organizational and societal
norms of modern medical
care delivery do not value
this activity. We try to         Resources
                                                          Attentional Dynamics
review beyond the quality                                                                Blunt-end
of the clinician’s decision                         Knowledge         Strategic Factors
making. Clinicians act at
the “sharp” end of the                            Operational System as Cognitive System

system. But often are set-                                Resources and Constraints

up to fail because the blunt
end defines the resources                             Organizational Context
that are available for the
work the clinicians are trying to perform.
We have found Charles Vincent’s adaptation
of error analysis in medicine useful.
Identifying care management problems
(CMP’s) and then the contributory factors,
reminds us how often the systemic factors,
not the clinicians, are the major agents
biasing the system to behave in the manner
observed. In this case, if third party payers
do not reimburse physicians or
paraprofessionals for prep time, why are we
surprised that patient education is poor?


2) Normal and abnormal sleep states: (A
brief comment.) We have provided quite a
bit of sedation with short acting medications
such as propofol and remifentanil. We have
had to explain to parents and other clinicians
that just because a child is sleeping, that does
not mean a child is “sedated”. For the
parents reading this newsletter, we all relate
to how difficult it is to arouse our children
are during a nap or in the middle of the
night. When a child has received short acting
medications, we do not always wait for
spontaneous awakening (an exhausted child
may sleep for hours despite only getting a
little propofol). In these situations, we
actively wake children up, otherwise our recovery process becomes log-jammed.

3) The impact of sedative technique on the test result/interpretability. This is a serious
issue with EEG’s and other tests of CNS function. (Voiding cystouretherogram (VCUG)
in the child that has bladder neck sphincter control is similarly demanding.) In the EEG,
we worry that sedative drugs could increase either the false positives or the false
negatives of the assessment for seizures. Many sedative drugs ( ketamine, methohexital,
enflurane, etc.) have been reported to produce seizure like EEG signals and could lead to
false positive results. Other drugs (midazolam, pentobarbital, etc.) clearly raise the
seizure threshold and might lead to false negative EEGs. (Apparently, neurologists
debate the use of chloral hydrate.) Practically speaking, pediatric EEG’s are difficult to
perform without any medications in the young child, and chloral hydrate’s effects are
minimal (but not zero). VCUG sedation has the same dilemma. Filling the bladder with
contrast under sedation or anesthesia in the child that is continent, will not produce a
reflex contraction of the bladder, but can allow over distention of the bladder and reflux
into the ureters that is not physiological. Most concerning in this case is the idea that
changing grade 2 to grade 3 reflux might alter treatment (medical vs. surgical approach).
Solutions: No easy answers when trying to create more effective, yet safe systems of
care. Our pediatric sedation group has been asked to help on EEG’s for difficult patients.
1) Prep: Our Child Life Specialist is doing preparation (philanthropy is funding this
activity) and has developed materials that can be provided over the phone, over the web,
and in person (booklets) to orient children and their parents and desensitize them to the
people and environments where the tests will occur. It seems that actual photos work
better than cartoons to decrease how “scary” the people and procedure appears. For
example, in older children, seeing the EEG wires being applied to another child helps
decrease anxiety. In addition, describing the sounds (the MRI machine sounds like a
washing machine, or a vacuum cleaner) and the smells (sevo smells like a magic marker)
to expect is important.

2) A novel sedation strategy: Given the short half-life of an ultra short acting sedative
hypnotic like propofol (t1/2 < 5min in a five year old) and that the EEG effects are
measurable (EEG monitors are available to help anesthesiologists determine “awake vs.
asleep” status in paralyzed patients), we have performed three EEG’s recently in children
with developmental delay that were predicted to be especially difficult. The pediatric
neurologist and the anesthesiologist came up with an approach to induce sleep in a sleep
deprived child and then leverage short half life drugs to perform the EEG while still
asleep but “non-sedated” in that the short acting medications would have little residual
clinical effect. We used brief inhalational anesthesia (nitrous oxide and sevoflurane for
less than 3 minutes) to place an IV and give a bolus of propofol 1mg/kg. Marking and
electrode placement was done with propofol maintained at 50mcg/kg/min. The room was
kept very warm, music played, lights dimmed, etc to maintain sleep. When
manipulations were complete, the child’s head and body were wrapped in a warm
blanket. The infusion was stopped and 20min later EEG recording performed. At the
conclusion of the study the child was awakened and this transition recorded. The
children emerged quite calmly with the parents present. The three cases each took about
1.5-2hrs total to complete.

Conclusions: As a result of this report, we hope to alert readers to challenging issues
regarding functional tests of the nervous system. While we mainly describe EEG, we
suspect there are similar issues for somatosensory evoked potentials, EMG’s and others.
We are hopeful that ultra-short acting medications might allow for sleep induction with
the ability to perform the test while “staying asleep”.

Thanks for the reports that are being submitted, please keep them coming so that we all
can learn from them.

				
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