drugset
drugset / Trial / NCT01925898

A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.

NCT01925898 ↗

Phase 4 Unknown 60 enrolled Assaf-Harofeh Medical Center
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only one randomized controlled study oral ketamine has been used successfully for procedural sedation for laceration repair. A recent study showed that the combination of oral midazolam and oral ketamine provided deeper sedation compared with oral midazolam alone. However children treated wuth the combination of midazolam and ketamine required longer recovery Hypothesis: Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation for laceration repair.

Timeline

Start
2013-08
Primary completion
2014-02
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 5 mg/kg Oral
Comparator Midazolam Small molecule 0.7 mg/kg Oral

Indications

No indication recorded.