Andis Graudins1, Robert Meek2, Dianna Egerton-Warburton2, Ed Oakley3, Robert Seith4. 1. Monash Health Emergency Medicine Research Group, Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia; Monash Health Emergency Medicine Program, Monash Health, Clayton, Victoria, Australia. Electronic address: andis.graudins@monashhealth.org. 2. Monash Health Emergency Medicine Research Group, Department of Medicine, School of Clinical Sciences at Monash Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Victoria, Australia; Monash Health Emergency Medicine Program, Monash Health, Clayton, Victoria, Australia. 3. Department of Paediatrics, University of Melbourne, and Department of Emergency Medicine, the Royal Children's Hospital, Parkville, Victoria, Australia. 4. Pediatric Emergency Department, Monash Medical Center, Monash Health, Clayton, Victoria, Australia; Monash Health Emergency Medicine Program, Monash Health, Clayton, Victoria, Australia.
Abstract
STUDY OBJECTIVE: We compare the analgesic effectiveness of intranasal fentanyl and ketamine in children. METHODS: This was a double-blind, randomized, controlled trial comparing fentanyl at 1.5 μg/kg with ketamine at 1 mg/kg in children aged 3 to 13 years and weighing less than 50 kg, with isolated limb injury and pain of more than 6 of 10 at triage. The sample size was 40 in each arm. Subjects were coadministered oral ibuprofen at 10 mg/kg. The primary outcome was median pain rating reduction at 30 minutes. Secondary outcomes were pain rating reduction at 15 and 60 minutes, subjective improvement and satisfaction, University of Michigan Sedation Score, adverse events, and rescue analgesia. RESULTS:Eighty children enrolled, and 73 were available for analysis: 37 fentanyl and 36ketamine. Median age was 8 years; 63% were male children; median baseline pain rating was 80 mm. At 30 minutes, median reductions for ketamine and fentanyl were 45 and 40 mm, respectively (difference 5 mm; 95% confidence interval [CI] -10 to 20 mm). Reductions exceeded 20 mm for ketamine and fentanyl in 82% and 79% of patients, respectively (difference 3%; 95% CI -22% to 16%). Pain rating reduction was maintained to 60 minutes in both groups. Satisfaction was reported for ketamine and fentanyl by 83% and 72% of patients, respectively (difference 11%; 95% CI -9% to 30%). Adverse events, mainly mild, were reported for ketamine and fentanyl by 78% and 40% of patients, respectively (difference 38%; 95% CI -58% to 16%). Three ketamine patients had a moderate degree of sedation by University of Michigan Sedation Score. CONCLUSION:Intranasal fentanyl and ketamine were associated with similar pain reduction in children with moderate to severe pain from limb injury. Ketamine was associated with more minor adverse events.
RCT Entities:
STUDY OBJECTIVE: We compare the analgesic effectiveness of intranasal fentanyl and ketamine in children. METHODS: This was a double-blind, randomized, controlled trial comparing fentanyl at 1.5 μg/kg with ketamine at 1 mg/kg in children aged 3 to 13 years and weighing less than 50 kg, with isolated limb injury and pain of more than 6 of 10 at triage. The sample size was 40 in each arm. Subjects were coadministered oral ibuprofen at 10 mg/kg. The primary outcome was median pain rating reduction at 30 minutes. Secondary outcomes were pain rating reduction at 15 and 60 minutes, subjective improvement and satisfaction, University of Michigan Sedation Score, adverse events, and rescue analgesia. RESULTS: Eighty children enrolled, and 73 were available for analysis: 37 fentanyl and 36 ketamine. Median age was 8 years; 63% were male children; median baseline pain rating was 80 mm. At 30 minutes, median reductions for ketamine and fentanyl were 45 and 40 mm, respectively (difference 5 mm; 95% confidence interval [CI] -10 to 20 mm). Reductions exceeded 20 mm for ketamine and fentanyl in 82% and 79% of patients, respectively (difference 3%; 95% CI -22% to 16%). Pain rating reduction was maintained to 60 minutes in both groups. Satisfaction was reported for ketamine and fentanyl by 83% and 72% of patients, respectively (difference 11%; 95% CI -9% to 30%). Adverse events, mainly mild, were reported for ketamine and fentanyl by 78% and 40% of patients, respectively (difference 38%; 95% CI -58% to 16%). Three ketaminepatients had a moderate degree of sedation by University of Michigan Sedation Score. CONCLUSION: Intranasal fentanyl and ketamine were associated with similar pain reduction in children with moderate to severe pain from limb injury. Ketamine was associated with more minor adverse events.
Authors: D Häske; B W Böttiger; B Bouillon; M Fischer; Gernot Gaier; B Gliwitzky; M Helm; P Hilbert-Carius; B Hossfeld; B Schempf; A Wafaisade; M Bernhard Journal: Anaesthesist Date: 2020-02 Impact factor: 1.041
Authors: Daniel S Tsze; Maria Ieni; Daniel B Fenster; John Babineau; Joshua Kriger; Bruce Levin; Peter S Dayan Journal: Ann Emerg Med Date: 2016-11-04 Impact factor: 5.721
Authors: David Häske; Bernd W Böttiger; Bertil Bouillon; Matthias Fischer; Gernot Gaier; Bernhard Gliwitzky; Matthias Helm; Peter Hilbert-Carius; Björn Hossfeld; Christoph Meisner; Benjamin Schempf; Arasch Wafaisade; Michael Bernhard Journal: Dtsch Arztebl Int Date: 2017-11-17 Impact factor: 5.594