A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department.

Abstract

STUDY 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.

CONCLUSION:

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: Meredith Borland, Ian Jacobs, Barbara King, Debra O'Brien
• Journal: Annals of emergency medicine (Ann Emerg Med) Vol. 49 Issue 3 Pg. 335-40 (Mar 2007) ISSN: 1097-6760 [Electronic] United States
• PMID: 17067720 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Analgesics, Opioid
• Morphine
• Fentanyl

Topics

• Acute Disease
• Administration, Intranasal
• Adolescent
• Analgesics, Opioid (administration & dosage, pharmacokinetics)
• Child
• Dose-Response Relationship, Drug
• Double-Blind Method
• Emergency Medicine (methods)
• Emergency Service, Hospital
• Fentanyl (administration & dosage, pharmacokinetics)
• Fractures, Bone (complications)
• Humans
• Injections, Intravenous
• Morphine (administration & dosage, pharmacokinetics)
• Pain (diagnosis, drug therapy, etiology)
• Pain Measurement
• Patient Satisfaction
• Pediatrics (methods)
• Prospective Studies
• Therapeutic Equivalency
• Treatment Outcome