drugset / Trial / NCT02408302

Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children

NCT02408302 ↗

Phase 4 Unknown 90 enrolled Carmel Medical Center
RandomizedParallel-groupOpen-label

Summary

Currently Midazolam sedation is the standard of care for minor invasive procedures in pediatric patients; its use is restricted to two routes of administration for this purpose oral and intranasal. A third route of administration (buccal) is tested and approved for seizure management. In the investigators' study the researchers investigate the buccal route of administration versus oral or intranasal administration for sedation. The investigators' hypothesis is that buccal route of administration is more convenient than intranasal and better absorbed than oral.

Timeline

Start
2015-04
Primary completion
2016-02
Completion
2016-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 0.3 mg/kg Oral
Comparator Midazolam Small molecule 0.5 mg/kg Oral
Comparator Midazolam Small molecule 0.7 mg/kg Oral

Indications

No indication recorded.