Pediatrics/concepts
Consensus-Based Recommendations for Standardizing Terminology and Reporting Adverse Events for Emergency Department Procedural Sedation and Analgesia in Children

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Children commonly require sedation and analgesia for procedures in the emergency department. Establishing accurate adverse event and complications rates from the available literature has been difficult because of the difficulty in aggregating results from previous studies that have used varied terminology to describe the same adverse events and outcomes. Further, serious adverse events occur infrequently, necessitating the study of large numbers of children to assess safety. These limitations prevent the establishment of a sufficiently large database on which evidence-based practice guidelines may be based. We assembled a panel of pediatric sedation researchers and experts to develop consensus-based recommendations for standardizing procedural sedation and analgesia terminology and reporting of adverse events. Our goal was to create a uniform reporting mechanism for future studies to facilitate the aggregation and comparison of results.

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

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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.

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