Pediatric blood & cancer · 2016
Intranasal fentanyl for initial treatment of vaso-occlusive crisis in sickle cell disease.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Fein Daniel M, Avner Jeffrey R, Scharbach Kathryn, Manwani Deepa, Khine Hnin
Аннотация
BACKGROUND: Analgesia administration for children with vaso-occlusive crises is often delayed in the emergency department. Intranasal fentanyl (INF) has been shown to be safe and effective in providing rapid analgesia for other painful conditions. Our objective was to determine if children with a vaso-occlusive crisis (VOC) who received initial treatment with INF compared to placebo achieved a greater decrease in pain score after 20 min.
PROCEDURE: This was a randomized, double-blind, placebo-controlled trial. Children with sickle cell disease, 3-20 years old, not taking daily opiates were eligible for the study. Subjects who presented to the emergency department with a pain score ≥6 were randomized to either a single dose of INF (2 μg/kg, maximum 100 μg) or an equivalent volume of intranasal saline. Pain scores were obtained using a modified Wong-Baker FACES pain scale prior to the administration of study drug and at 10, 20, and 30 min afterward. Additional analgesic medication was given per standard protocol.
RESULTS: Forty-nine subjects completed the study (24 fentanyl and 25 placebo). Subjects who received INF had a greater decrease in median pain score at 20 min compared to placebo (2 [interquartile range, (IQR) 0.5-4] vs. 1 [IQR 0-2], P = 0.048), but not at 10 or 30 min. There were no serious adverse events in either group.
CONCLUSION: Children who received INF had a greater decrease in pain score at 20 min compared to those who received placebo. Further studies should evaluate how to best incorporate INF into the emergency care of a child with a VOC.
PROCEDURE: This was a randomized, double-blind, placebo-controlled trial. Children with sickle cell disease, 3-20 years old, not taking daily opiates were eligible for the study. Subjects who presented to the emergency department with a pain score ≥6 were randomized to either a single dose of INF (2 μg/kg, maximum 100 μg) or an equivalent volume of intranasal saline. Pain scores were obtained using a modified Wong-Baker FACES pain scale prior to the administration of study drug and at 10, 20, and 30 min afterward. Additional analgesic medication was given per standard protocol.
RESULTS: Forty-nine subjects completed the study (24 fentanyl and 25 placebo). Subjects who received INF had a greater decrease in median pain score at 20 min compared to placebo (2 [interquartile range, (IQR) 0.5-4] vs. 1 [IQR 0-2], P = 0.048), but not at 10 or 30 min. There were no serious adverse events in either group.
CONCLUSION: Children who received INF had a greater decrease in pain score at 20 min compared to those who received placebo. Further studies should evaluate how to best incorporate INF into the emergency care of a child with a VOC.