drugset / Trial / NCT01948908

Volumes of Administration for Intranasal Midazolam

NCT01948908

Phase 2 Completed 99 enrolled Columbia University
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to determine exactly how much drug volume should be administered into each nare, so that the drug absorption can be maximized and the amount that runs out of the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug given intranasally. The investigators will determine this ideal "volume of administration" by studying intranasal midazolam in children who require sedation to facilitate laceration repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic outcomes associated with each volume of administration. We will block randomize children to receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200 microliters (mcL), 500 mcL, or 1000 mcL.

Timeline

Start
2013-06
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule 0.5 mg/kg Intranasal

Indications

No indication recorded.