A Clinical Trial of Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
Status:
Unknown status
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
Background: 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 a few studies oral ketamine has been used successfully for procedural sedation as well.
The efficacy of using a combination of oral midazolam and oral ketamine for procedural
sedation has been studied only for invasive procedures in children with malignancies. No
randomized controedll studies were performed using this sedative combination in children
requiring laceration repair. Objectives: To determine the efficacy of adding oral ketamine to
oral midazolam for procedural sedation in children requiring laceration repair compares to
oral midazolam plus placebo. Design: A randomized, double blind, placebo-controlled study.
Setting: Pediatric Emergency Department. Participants: Children 1 to 10 years with laceration
requiring sedation. Interventions: Eligible patients will be randomly assigned to one of two
treatment groups: oral midazolam plus oral placebo group and oral midazolam plus oral
ketamine group. Both groups will be given the same volume of medications. Midazolam will be
given orally in a dose of 0.5 mg/kg (max.-15 mg) with placebo or 0.5 mg/kg (max.- 15 mg) with
oral ketamine in a dose of 5 mg/kg. The medical staff will be blinded to the treatment given.
Patient monitoring will be conducted according to the American Academy of Pediatrics (APP)
and the Israeli health ministry guidelines for monitoring and management of pediatric
patients during and after sedation for diagnostic and therapeutic procedures. Main outcome
measures: Pain score: Visual Analog Score (VAS) - by parent. Data analysis: Descriptive
statistics will be used to describe the study population. Data will be analyzed using t-
tests for continuous data and Fisher exact test for categorical data.
Key words: sedation, children, ketamine, midazolam, emergency department.