PediatricsDoes adjunctive midazolam reduce recovery agitation after ketamine sedation for pediatric procedures? A randomized, double-blind, placebo-controlled trial☆
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INTRODUCTION
Ketamine has been established as a safe and effective sedative for painful emergency department pediatric procedures.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 The widespread acceptance of ketamine as an ED sedative may be limited by physician apprehension regarding recovery agitation. Ketamine can induce dreaming and hallucinations during recovery, and unpleasant reactions and nightmares have limited its use in adults. Children, however, are less prone to unpleasant recovery reactions and display
MATERIALS AND METHODS
The study was performed in the ED of a combined university medical center and children’s hospital with a yearly census of 44,000. We selected children aged 12 months to 15 years for ketamine sedation if they required short painful procedures (especially procedures in which immobilization was required) or examinations likely to produce emotional distress. We attempted to enroll consecutive children treated by 6 physicians, all of whom were faculty or fellows in pediatric emergency medicine. We
RESULTS
Participant flow is shown in Figure 1.Interobserver agreement between treating physicians and nurses was substantial across all assessments (Table 1).Empty Cell Physician Rating Nurse Rating Interobserver Agreement Presedation agitation, median (IQR) 7 (0–22) 6 (1–34.5) Spearman ρ=0.621 SD of differences=16 Recovery agitation, median (IQR) 5 (2–17) 6.5 (1–20.5) Spearman ρ=0.640 SD of differences=15 External stimulation, median (IQR) 33.5 (13–44.5) 42
DISCUSSION
This is the first study evaluating the use of adjunctive benzodiazepines during pediatric ketamine sedation. We found no evidence of benefit with adjunctive midazolam in improvement of recovery agitation, character, or duration or in the efficacy of sedation itself. The CIs for each of these comparisons (Table 3) demonstrate that our study had sufficient power to exclude clinically important differences. Thus our results do not support the common practice of benzodiazepine prophylaxis for
Acknowledgements
We thank our ED nurses for their invaluable assistance in patient monitoring and parental education; Norman Hamada, PharmD, for his assistance in preparing the study vials; and Arit Mbagwu, MD, and Thomas K Denmark, MD, for their help in enrolling study subjects. We thank James Li, MD, and William Wittlake, MD, for their review of the manuscript and many helpful suggestions.
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2016, American Journal of Emergency MedicineCitation Excerpt :Two clinical practice guidelines for ED ketamine use state that the minimum dose of intravenous (IV) ketamine at which the dissociative state can be reliably achieved in children is 1.5 mg/kg IV, and common loading doses are 1.5 to 2 mg/kg [8,9]. Despite these recommendations, prospective, ED comparative trials have administered ketamine IV in 0.5-mg increments to a maximum of 2 mg [10], as 1 mg/kg [11–15], 1.5 mg/kg [16], 1 to 2 mg/kg [17], and 2 mg/kg [18]. Although previous studies using ketamine for procedural sedation and analgesia did not find a significant change in adverse event rates unless the initial IV dose exceeded 2.5 mg/kg or the total dose exceeded 5.0 mg/kg, this wide practice variation of ketamine administration may impact sedation efficacy, duration of sedation, and, potentially, adverse events [5,6].
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