Nirupama Kannikeswaran1, Mary Lieh-Lai2, Monica Malian3, Bo Wang4, Ahmad Farooqi5, Mark G Roback6. 1. Carman and Ann Adams Department of Pediatrics, Division of Emergency Medicine, Wayne State University School of Medicine, Children's Hospital of Michigan, Detroit, MI 48201. Electronic address: nkannike@dmc.org. 2. Wayne State University School of Medicine, Chicago, IL 60654; Accreditation Council for Graduate Medical Education, Chicago, IL 60654. 3. Department of Pharmacy Services, Children's Hospital of Michigan, Detroit, MI 48201. 4. Wayne State University School of Medicine, Detroit, MI 48201. 5. Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI 48201. 6. University of Minnesota Medical School, Minneapolis, MN 55455.
Abstract
OBJECTIVE: The objective of the study is to compare need for redosing, sedation efficacy, duration, and adverse events between 3 commonly administered doses of parenteral ketamine in the emergency department (ED). METHODS: We conducted a prospective, double-blind, randomized controlled trial on a convenience sample of children 3 to 18years who receivedintravenous ketaminefor procedural sedation. Children from each age group (3-6, 7-12, and 13-18years) were assigned in equal numbers to 3 dosing groups (1, 1.5, and 2mg/kg) using random permuted blocks. The primary outcome measure was need for ketamine redosing to ensure adequate sedation. Secondary outcome measures were sedation efficacy, sedation duration, and sedation-related adverse events. RESULTS: A total of 171 children were enrolled of whom 125 (1mg/kg, 50; 1.5mg/kg, 35; 2mg/kg, 40) received the randomized dose and were analyzed. The need for ketamine redosing was higher in the 1mg/kg group (8/50; 16.0% vs 1/35; 2.9% vs 2/40; 5.0%). There was no significant difference in the median Ramsay sedation scores (5.5 [interquartile range {IQR}, 4-6] vs 6 [IQR, 4-6] vs 6 [IQR, 5-6]), FACES-R score (0 [IQR, 0-4] vs 0 [IQR, 0-0] vs 0 [IQR, 0-0]), sedation duration in minutes (23 [IQR, 19-38] vs 24.5 [IQR, 17.5-34.5] vs 23 [IQR, 19-29]), and adverse events (10.0% vs 14.3% vs 10.0%) between the 3 dosing groups. Physician satisfaction was lower in the 1mg/kg group (79.6% vs 94.1% vs 97.3%). CONCLUSIONS: Adequate sedation was achieved with all 3 doses of ketamine. Higher doses did not increase the risk of adverse events or prolong sedation. Ketamine administered at 1.5 or 2.0mg/kg intravenous required less redosing and resulted in greater physician satisfaction.
RCT Entities:
OBJECTIVE: The objective of the study is to compare need for redosing, sedation efficacy, duration, and adverse events between 3 commonly administered doses of parenteral ketamine in the emergency department (ED). METHODS: We conducted a prospective, double-blind, randomized controlled trial on a convenience sample of children 3 to 18years who received intravenous ketamine for procedural sedation. Children from each age group (3-6, 7-12, and 13-18years) were assigned in equal numbers to 3 dosing groups (1, 1.5, and 2mg/kg) using random permuted blocks. The primary outcome measure was need for ketamine redosing to ensure adequate sedation. Secondary outcome measures were sedation efficacy, sedation duration, and sedation-related adverse events. RESULTS: A total of 171 children were enrolled of whom 125 (1mg/kg, 50; 1.5mg/kg, 35; 2mg/kg, 40) received the randomized dose and were analyzed. The need for ketamine redosing was higher in the 1mg/kg group (8/50; 16.0% vs 1/35; 2.9% vs 2/40; 5.0%). There was no significant difference in the median Ramsay sedation scores (5.5 [interquartile range {IQR}, 4-6] vs 6 [IQR, 4-6] vs 6 [IQR, 5-6]), FACES-R score (0 [IQR, 0-4] vs 0 [IQR, 0-0] vs 0 [IQR, 0-0]), sedation duration in minutes (23 [IQR, 19-38] vs 24.5 [IQR, 17.5-34.5] vs 23 [IQR, 19-29]), and adverse events (10.0% vs 14.3% vs 10.0%) between the 3 dosing groups. Physician satisfaction was lower in the 1mg/kg group (79.6% vs 94.1% vs 97.3%). CONCLUSIONS: Adequate sedation was achieved with all 3 doses of ketamine. Higher doses did not increase the risk of adverse events or prolong sedation. Ketamine administered at 1.5 or 2.0mg/kg intravenous required less redosing and resulted in greater physician satisfaction.
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