A randomized, clinical trial of oral midazolam plus placebo versus oral midazolam plus oral transmucosal fentanyl for sedation during laceration repair

Pediatrics. 2002 May;109(5):894-7. doi: 10.1542/peds.109.5.894.


Objective: To determine whether a combination of oral transmucosal fentanyl (Fentanyl Oralet, Abbott Laboratories, North Chicago, IL) plus oral midazolam has an acceptable safety profile and is more effective than oral midazolam alone for sedation during laceration repair in a pediatric emergency department (ED).

Methods: Randomized, double-blind, placebo-controlled, clinical trial. Patients between 2 and 8 years of age who weighed >10 kg and presented to the ED with a laceration in need of repair under sedation were eligible for inclusion. All patients received oral midazolam (0.5 mg/kg; maximum dose 10 mg) and either fentanyl (5-10 microg/kg) or placebo in oralet form. Data collected every 5 minutes included the following: heart rate, oxygen saturation, respiratory rate, pain as measured on a Children's Hospital of Eastern Ontario Pain Score (CHEOPS) scale (range: 4-13), and an activity scale (range: 1-5). Effectiveness of sedation was measured by CHEOPS and activity scores compared between the treatment groups.

Results: Fifty-one patients were randomized to receive oral midazolam plus fentanyl (N = 28) or oral midazolam plus placebo (N = 23). Age, weight, gender, or baseline pain and activity scores did not differ between the 2 groups. Seven patients in the fentanyl group vomited compared with 0 patients in the placebo group. Three patients in the fentanyl group and no patients in the placebo group had brief oxygen saturation below 93% on room air. The mean pain score within 5 minutes of the start of the procedure did not differ between the 2 groups (fentanyl group, 9.4 versus placebo group, 8.8). Mean activity scores within 5 minutes of the start of the procedure were also similar (fentanyl group, 4.3 versus placebo group, 4.3).

Conclusions: The addition of oral transmucosal fentanyl to oral midazolam did not improve pain or activity scores in pediatric patients given sedation for laceration repair. Patients who received Fentanyl Oralet suffered significantly more side effects despite the relatively low doses administered in this study. Oral transmucosal fentanyl should not be used for procedural sedation in the ED.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adjuvants, Anesthesia / administration & dosage*
  • Administration, Oral
  • Anesthesia / methods*
  • Child
  • Child, Preschool
  • Conscious Sedation / methods
  • Double-Blind Method
  • Female
  • Fentanyl / administration & dosage*
  • Humans
  • Hypnotics and Sedatives / administration & dosage*
  • Lacerations / surgery*
  • Male
  • Midazolam / administration & dosage*
  • Placebos
  • Treatment Outcome


  • Adjuvants, Anesthesia
  • Hypnotics and Sedatives
  • Placebos
  • Midazolam
  • Fentanyl