NCT01925898

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 1 Year – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lacerations

Interventions

Type	Name	Description
DRUG	Midazolam - active comparator	Oral midazolam - 0.7mg/kg single dose
DRUG	Experimental Arm: Ketamine	Oral Ketamine 5mg/kg Single dose

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-02-01
• Completion: 2014-07-01
• First posted: 2013-08-20
• Last updated: 2014-01-22

Locations

1 site across 1 country: Israel