To examine the safety and effectiveness of intranasal midazolam and fentanyl used in combination for laceration repair in the pediatric emergency department.

We performed a retrospective chart review of a random sample of 546 children less than 18 years of age who received both intranasal midazolam and fentanyl for laceration repair in the pediatric emergency department at a large, urban children's hospital. Records were reviewed from April 1, 2012 to June 31, 2015. The primary outcome measures were adverse events and failed laceration repair.

Of the 546 subjects analyzed, 5.1% had multiple lacerations. Facial lacerations were the most common site representing 70.3%, followed by lacerations to the hand (9.9%) and leg (7.0%). The median length of lacerations was 1.5 cm [1.0–2.5]. The median dose of fentanyl was 2.0 μg/kg [1.9–2.0] and midazolam was 0.2 mg/kg [0.19–0.20].

There were no serious adverse events reported. The rate of minor side effects was 0.7% (95% CI 0.2% to 1.9%); 0.5% (95% CI 0.1% to 1.6%) experienced anxiety and 0.2% (95% CI 0.0% to 1.0%) vomited. No patients developed hypotension or hypoxia. Of the 546 patients, 2.4% (95% CI 1.3% to 4.0%) experienced a treatment failure. 2.0% (95% CI 1.3% to 4.0%) required IV sedation and 0.4% (95% CI 0.0% to 1.3%) were repaired in the operating room.

Our results suggest that the combination of INM and INF may be a safe and effective strategy for procedural sedation in young children undergoing simple laceration repair.