Lacertaions Clinical Trial
Official title:
A Randomized, Clinical Trial of Oral Midazolam Plus Placebo Versus Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | July 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 10 Years |
| Eligibility |
Inclusion Criteria: - Age: 1 years - 10 years - Any child with laceration requiring sedation Exclusion Criteria: - Major trauma - Closed head injury associated with loss of consciousness - Abnormal neurologic examination in a previously normal child - Significant developmental delay or baseline neurological deficit - A patient with seizures - Elevated intra-cranial pressure - Hypersensitivity to midazolam or ketamine - Hypertension - Hyperthyroidism or a patient receiving thyroid replacement - alcohol intoxication or a history of alcohol abuse - Acute or chronic respiratory, cardiac, renal or hepatic abnormalities - Glaucoma - Known psychiatric disease - ASA score of more than 2 - Informed consent cannot be obtained from legal guardian |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Pediatric Emergency Department | Assaf Harofeh, Zerifin |
| Lead Sponsor | Collaborator |
|---|---|
| Assaf-Harofeh Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain score: Visual analog score (VAS)- by parent | participants will be followed for the duration of hospital stay, an expected average of 3 hours | Yes | |
| Secondary | Pain score: Visual analog score (VAS)- by a physician | while in the ED for about 3 hours | No |