title: A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department.
abstract: OBJECTIVE
  We compare the efficacy of intranasal fentanyl versus intravenous morphine in a pediatric population presenting to an emergency department (ED) with acute long-bone fractures.
  
  
  METHODS
  We conducted a prospective, randomized, double-blind, placebo-controlled, clinical trial in a tertiary pediatric ED between September 2001 and January 2005. A convenience sample of children aged 7 to 15 years with clinically deformed closed long-bone fractures was included to receive either active intravenous morphine (10 mg/mL) and intranasal placebo or active intranasal concentrated fentanyl (150 microg/mL) and intravenous placebo. Exclusion criteria were narcotic analgesia within 4 hours of arrival, significant head injury, allergy to opiates, nasal blockage, or inability to perform pain scoring. Pain scores were rated by using a 100-mm visual analog scale at 0, 5, 10, 20, and 30 minutes. Routine clinical observations and adverse events were recorded.
  
  
  RESULTS
  Sixty-seven children were enrolled (mean age 10.9 years [SD 2.4]). Fractures were radius or ulna 53 (79.1%), humerus 9 (13.4%), tibia or fibula 4 (6.0%), and femur 1 (1.5%). Thirty-four children received intravenous (i.v.) morphine and 33 received intranasal fentanyl. Statistically significant differences in visual analog scale scores were not observed between the 2 treatment arms either preanalgesia or at 5, 10, 20, or 30 minutes postanalgesia (P=.333). At 10 minutes, the difference in mean visual analog scale between the morphine and fentanyl groups was -5 mm (95% confidence interval -16 to 7 mm). Reductions in combined pain scores occurred at 5 minutes (20 mm; P=.000), 10 minutes (4 mm; P=.012), and 20 minutes (8 mm; P=.000) postanalgesia. The mean total INF dose was 1.7 microg/kg, and the mean total i.v. morphine dose was 0.11 mg/kg. There were no serious adverse events.
  
  
  CONCLUSIONS
  Intranasal fentanyl delivered as 150 microg/mL at a dose of 1.7 microg/kg was shown to be an effective analgesic in children aged 7 to 15 years presenting to an ED with an acute fracture when compared to intravenous morphine at 0.1 mg/kg.
authors.affiliation: Princess Margaret Hospital for Children, Subiaco, WA, Australia. Meredith.Borland@health.wa.gov.au
authors.forename: Meredith
authors.initials: M
authors.lastname: Borland
authors.forename: Ian
authors.initials: I
authors.lastname: Jacobs
authors.forename: Barbara
authors.initials: B
authors.lastname: King
authors.forename: Debra
authors.initials: D
authors.lastname: O'Brien
mesh_terms: D000208:Acute Disease; D000281:Administration, Intranasal; D000293:Adolescent; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000493:pharmacokinetics; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004635:Emergency Medicine / Q000379:methods*; D004636:Emergency Service, Hospital; D005283:Fentanyl / Q000008:administration & dosage* / Q000493:pharmacokinetics; D050723:Fractures, Bone / Q000150:complications; D006801:Humans; D007275:Injections, Intravenous; D009020:Morphine / Q000008:administration & dosage* / Q000493:pharmacokinetics; D010146:Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement; D017060:Patient Satisfaction; D010372:Pediatrics / Q000379:methods*; D011446:Prospective Studies; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D009020:Morphine; D005283:Fentanyl