drugset / Trial / NCT02356705

Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2

NCT02356705 ↗

Phase 4 Completed 42 enrolled Jennifer Victory, RN, CCRC
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration

Timeline

Start
2015-01
Primary completion
2017-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lidocaine Other / unclassified 4 % Intranasal
Comparator Midazolam Small molecule 0.2 mg/kg Intranasal

Indications

No indication recorded.