drugset / Trial / NCT03085563

A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department

NCT03085563

Phase 4 Completed 63 enrolled University of Colorado, Denver
RandomizedParallel-groupOpen-labelOther

Summary

The objective of this project is to compare the sedative effects of intranasal midazolam versus inhaled nitrous oxide (N2O) for minor procedures in the pediatric emergency department. The primary outcome will be length of stay (LOS) in the emergency department (ED) stay for minor procedures. Secondarily the investigators will compare patient/family and provider satisfaction while using either intranasal midazolam or N2O for minimal sedation. The investigators hypothesize that the total length of stay for children undergoing minor procedures in the ED will be lower for N2O, as compared to intranasal midazolam. The investigators also hypothesize that patient/family and provider satisfaction will be higher with N2O and adverse effects will not differ between N2O and intranasal midazolam. Patients will receive either intranasal midazolam or N2O for minor procedures. Following the enrollment period, data will be analyzed and the two will be compared. Total length of stay, patient/family and provider satisfaction will be studied.

Timeline

Start
2017-05-24
Primary completion
2018-11-08
Completion
2018-11-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 0.4 mg/kg Intranasal
Comparator Nitrous Oxide Other / unclassified Inhaled

Indications

No indication recorded.