The PICHFORK (Pain in Children Fentanyl or Ketamine) trial: a randomized controlled trial comparing intranasal ketamine and fentanyl for the relief of moderate to severe pain in children with limb injuries

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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 ?g/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 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. ? 2014 American College of Emergency Physicians.
Original languageEnglish
Pages (from-to)248 - 254
Number of pages7
JournalAnnals of Emergency Medicine
Volume65
Issue number3
DOIs
Publication statusPublished - 2015

Cite this

@article{50af1422c03448da9fe710b6fb82be43,
title = "The PICHFORK (Pain in Children Fentanyl or Ketamine) trial: a randomized controlled trial comparing intranasal ketamine and fentanyl for the relief of moderate to severe pain in children with limb injuries",
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 ?g/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 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. ? 2014 American College of Emergency Physicians.",
author = "Andis Graudins and Robert Meek and Diana Egerton-Warburton and Ed Oakley and Robert Seith",
year = "2015",
doi = "10.1016/j.annemergmed.2014.09.024",
language = "English",
volume = "65",
pages = "248 -- 254",
journal = "Annals of Emergency Medicine",
issn = "0196-0644",
publisher = "Elsevier",
number = "3",

}

TY - JOUR

T1 - The PICHFORK (Pain in Children Fentanyl or Ketamine) trial: a randomized controlled trial comparing intranasal ketamine and fentanyl for the relief of moderate to severe pain in children with limb injuries

AU - Graudins, Andis

AU - Meek, Robert

AU - Egerton-Warburton, Diana

AU - Oakley, Ed

AU - Seith, Robert

PY - 2015

Y1 - 2015

N2 - 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 ?g/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 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. ? 2014 American College of Emergency Physicians.

AB - 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 ?g/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 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. ? 2014 American College of Emergency Physicians.

UR - http://www.annemergmed.com/article/S0196-0644(14)01363-8/pdf

U2 - 10.1016/j.annemergmed.2014.09.024

DO - 10.1016/j.annemergmed.2014.09.024

M3 - Article

VL - 65

SP - 248

EP - 254

JO - Annals of Emergency Medicine

JF - Annals of Emergency Medicine

SN - 0196-0644

IS - 3

ER -