Safety and effectiveness of intranasal midazolam and fentanyl used in combination in the pediatric emergency department.

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

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.