Pediatrics/conceptsConsensus-Based Recommendations for Standardizing Terminology and Reporting Adverse Events for Emergency Department Procedural Sedation and Analgesia in Children
Section snippets
Introduction and Importance
A large number of children receive procedural sedation and analgesia for diagnostic and therapeutic procedures in emergency departments (EDs) each year. Although it is critical to establish evidence-based practice in procedural sedation, efforts have been limited by an inability to aggregate results from existing studies. Practice is varied and results are reported inconsistently because investigators do not have a standardized set of definitions and reporting guidelines to follow.1, 2, 3, 4, 5
Materials and Methods
In July 2007, we assembled a panel of experts in procedural sedation and analgesia from 2 national collaborative pediatric emergency medicine research networks to establish consensus on uniform terms, definitions, and reporting for pediatric ED procedural sedation and analgesia. The panel chairs (M.B. and M.G.R.) approached the leadership of Pediatric Emergency Research Canada (PERC) and the Pediatric Emergency Care Applied Research Network (PECARN) for recommendations within their membership
Definition
Procedural sedation and analgesia, commonly referred to as “sedation,” is the use of anxiolytic, sedative, analgesic, or dissociative drugs to attenuate pain, anxiety, and motion to facilitate the performance of a necessary diagnostic or therapeutic procedure, provide an appropriate degree of amnesia or decreased awareness, and ensure patient safety.17, 18
Commentary
“Conscious sedation” is a misleading and outdated term that should no longer be used in research or clinical practice.19 The use of analgesic
Sedation Intervals
The time of sedation may be broken into 4 distinct intervals or phases: presedation, sedation, ED recovery, and postdischarge. Definitions, as well as subphases, are listed and defined in the Figure. It has been postulated that patients' risk for certain adverse events varies with their phase of sedation. Further study of adverse events and severity by sedation interval is warranted. We recommend that investigators record the times a patient begins and ends all phases and subphases.
Adverse Event Terminology
Accurate reporting of adverse events, the circumstances surrounding these events, and the interventions that result from their occurrence are of vital importance in the identification of the risk factors for and causes of adverse events associated with procedural sedation. The panel has recommended reporting all sedation events that result in an intervention or a change in disposition from the ED. All clinically relevant events, from minor (eg, mild desaturation requiring a jaw thrust) to more
Definition
Oxygen desaturation and one or more interventions are performed with the intention of improving the oxygen saturation.3, 38, 39, 40 The interventions include the following:
- a)
Vigorous tactile stimulation
- b)
Airway repositioning—chin lift, jaw thrust, neck extension, midline repositioning
- c)
Suctioning
- d)
Supplemental or increased oxygen delivery
- e)
Oral or nasal airway placement
- f)
Application of positive pressure or ventilation with bag mask
- g)
Tracheal intubation
Rationale
Definitions for oxygen desaturation use a combination of
Definition
Cessation or pause of ventilatory effort and one or more interventions are performed with the intention of stimulating or assisting ventilation. The interventions include the following:
- a)
Vigorous tactile stimulation
- b)
Application of bag mask with assisted ventilation
- c)
Tracheal intubation
- d)
Administration of reversal agents (opioid or benzodiazepine antagonists)
Rationale
Definitions for apnea describe the event as a loss of respiratory effort for a specified duration (eg, no respiratory effort for 30 seconds).2, 44
Definition
Suspicion* or confirmation† of oropharyngeal or gastric contents in the trachea during the sedation or physiologic recovery phase and the appearance of respiratory signs and symptoms that were not present before the sedation.56, 57 The new signs and symptoms must present before the end of the ED recovery phase (Figure).
- (i)
Physical signs
Cough
Crackles/rales
Decreased breath sounds
Tachypnea
Wheeze
Rhonchi
Respiratory distress
- (ii)
Oxygen requirement
Decrease in oxygen saturation from baseline, requiring
Definition
The motor reflex response characteristic of retching with or without the expulsion of gastric contents through the mouth or nose that occurs during sedation, ED recovery or postdischarge phases of sedation (Figure).
If the timing and extent of vomiting present a suspicion or confirmation of clinically apparent pulmonary aspiration, this adverse event must also be documented (Section III).
Rationale
Retching and vomiting are unpleasant for children and their families, may increase the risk of aspiration,
Definition
Pulse rate decreasing 2 standard deviations below normal for age as described by the American Heart Association (AHA) in the Pediatric Advanced Life Support (PALS) Provider Manual60 during the sedation or physiologic recovery phase (Figure) and one or more interventions are performed with the intention of improving pulse rate and cardiac output. The interventions include the following:
- a)
Suctioning
- b)
Vigorous tactile stimulation
- c)
Airway repositioning
- d)
Supplemental oxygen
- e)
Application of bag mask with
Definition
Involuntary, brief contraction of some muscle fibers, of a whole muscle, or of different muscles of one group, leading to movements of the corresponding body parts, usually not longer than 1/10 of a second (100 milliseconds)62and interferes with the procedure, requiring an intervention or administration of medications. Hiccupping is a form of myoclonus.
Definition
Involuntary muscle stiffening in extension that can be associated with shaking and interferes with the procedure, requiring an intervention or
Definition
Unanticipated restlessness or agitation in response to the administration of sedation drugs occurring during the sedation phase and results in the unplanned administration of reversal agents or alternative sedation drug(s), or results in a delay in the completion or discontinuation of the procedure.64
Rationale
Paradoxic reactions to sedation drugs have been reported and often result in an alteration or discontinuation of the sedation plan. These events are important and should be reported in research.
Definition
Definition
A neurologic deficit that was not present before sedation and does not resolve.
Commentary
This definition requires follow-up to confirm that the deficit was not transient.
Death
The irreversible cessation of cerebral function, spontaneous function of the respiratory system, and spontaneous function of the circulatory system.67
Other
Any effect of sedation not specifically mentioned above that results in an unexpected intervention should be described and documented.
Discussion
In this article, our consensus panel proposes a framework of definitions and recommendations for reporting sedation terminology, time intervals, and adverse events for procedural sedation research. It is our goal that through this standardization, future sedation studies will generate data that may be readily compared and aggregated. It is our further intention that this work facilitate study of the large populations of patients required to allow for definitive clinical care guidelines to be
References (67)
- et al.
Adverse events of procedural sedation and analgesia in a pediatric emergency department
Ann Emerg Med
(1999) - et al.
Preprocedural fasting and adverse events in procedural sedation and analgesia in a pediatric emergency department: are they related?
Ann Emerg Med
(2004) - et al.
Preprocedural fasting state and adverse events in children undergoing procedural sedation and analgesia in a pediatric emergency department
Ann Emerg Med
(2003) - et al.
Propofol sedation by emergency physicians for elective pediatric outpatient procedures
Ann Emerg Med
(2003) - et al.
Recommendations for uniform reporting of data following major trauma—the Utstein styleAn international Trauma Anaesthesia and Critical Care Society (ITACCS) initiative
Br J Anaesth
(2000) - et al.
Procedural sedation and analgesia in children
Lancet
(2006) - et al.
Procedural sedation terminology: moving beyond ”conscious sedation.”
Ann Emerg Med
(2002) - et al.
Fasting and emergency department procedural sedation and analgesia: a consensus-based clinical practice advisory
Ann Emerg Med
(2007) - et al.
Does adjunctive midazolam reduce recovery agitation after ketamine sedation for pediatric procedures?a randomized, double-blind, placebo-controlled trial
Ann Emerg Med
(2000) - et al.
Clinical practice guideline for emergency department ketamine dissociative sedation in children
Ann Emerg Med
(2004)
Intramuscular ketamine for pediatric sedation in the emergency department: safety profile in 1,022 cases
Ann Emerg Med
A randomized, controlled trial of IV versus IM ketamine for sedation of pediatric patients receiving emergency department orthopedic procedures
Ann Emerg Med
A prospective evaluation of ”ketofol” (ketamine/propofol combination) for procedural sedation and analgesia in the emergency department
Ann Emerg Med
Capnography and depth of sedation during propofol sedation in children
Ann Emerg Med
Propofol for procedural sedation in children in the emergency department
Ann Emerg Med
Predictors of adverse events with intramuscular ketamine sedation in children
Ann Emerg Med
Does midazolam alter the clinical effects of intravenous ketamine sedation in children?a double-blind, randomized, controlled, emergency department trial
Ann Emerg Med
Pulmonary aspiration in pediatric patients during general anesthesia: incidence and outcome
J Clin Anesth
Microstream capnography improves patient monitoring during moderate sedation: a randomized controlled trial
Pediatrics
Deep sedation with propofol by nonanesthesiologists: a prospective pediatric experience
Arch Pediatr Adolesc Med
Adverse events associated with procedural sedation and analgesia in a pediatric emergency department: a comparison of common parenteral drugs
Acad Emerg Med
Pediatric procedural sedation in the community emergency department: results from the ProSCED registry
Pediatr Emerg Care
Profiling adverse respiratory events and vomiting when using propofol for emergency department procedural sedation
Emerg Med Australas
Retrospective comparison of emergency department length of stay for procedural sedation and analgesia by nurse practitioners and physicians
Pediatr Emerg Care
Safe and efficacious use of procedural sedation and analgesia by nonanesthesiologists in a pediatric emergency department
Arch Pediatr Adolesc Med
Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein StyleA statement for health professionals from a task force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada and the Australian Resuscitation Council
Circulation
Recommended guidelines for uniform reporting of data from drowning: the ”Utstein Style.”
Circulation
Standardized reporting guidelines for studies evaluating risk stratification of ED patients with potential acute coronary syndromes
Acad Emerg Med
Cardiac arrest and cardiopulmonary resuscitation outcome reports: update and simplification of the Utstein templates for resuscitation registries: a statement for healthcare professionals from a task force of the international liaison committee on resuscitation
Circulation
Sedation and analgesia for procedures in children
N Engl J Med
Midazolam with ketamine: who benefits?
Ann Emerg Med
A comparison of intramuscular ketamine with high dose intramuscular midazolam with and without intranasal flumazenil in children before suturing
Emerg Med J
Continuous JudgementsHealth Measurement Scales
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Supervising editor: Steven M. Green, MD
Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article, that might create any potential conflict of interest. See the Manuscript Submission Agreement in this issue for examples of specific conflicts covered by this statement. This work was supported by a Canadian Institutes of Health Research Team Grant in Pediatric Emergency Medicine.
Publication dates: Available online November 20, 2008.