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: 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 ketamine patients had a moderate degree of sedation by University of Michigan Sedation Score.
  
  
  CONCLUSIONS
  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.affiliation: 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.
authors.forename: Andis
authors.initials: A
authors.lastname: Graudins
authors.affiliation: 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.
authors.forename: Robert
authors.initials: R
authors.lastname: Meek
authors.affiliation: 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.
authors.forename: Dianna
authors.initials: D
authors.lastname: Egerton-Warburton
authors.affiliation: Department of Paediatrics, University of Melbourne, and Department of Emergency Medicine, the Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Ed
authors.initials: E
authors.lastname: Oakley
authors.affiliation: Pediatric Emergency Department, Monash Medical Center, Monash Health, Clayton, Victoria, Australia; Monash Health Emergency Medicine Program, Monash Health, Clayton, Victoria, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Seith
mesh_terms: D000281:Administration, Intranasal; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D004636:Emergency Service, Hospital; D005121:Extremities / Q000293:injuries*; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007649:Ketamine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement
chemical_list: D000700:Analgesics; D000701:Analgesics, Opioid; D007649:Ketamine; D005283:Fentanyl