A Clinical Trial of Oral Midazolam Plus Oral Ketamine for Sedation During Laceration Repair

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.

Study Overview

• Status: Unknown
• Conditions: Lacertaions
• Intervention / Treatment: Drug: Ketamine; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Assaf Harofeh, Zerifin, Israel, 70300
    • Recruiting
    • Pediatric Emergency Department
    • Contact: Shiri Barkan, MD; Phone Number: 972 544385404; Email: shiri_barkan@yahoo.com
    • Principal Investigator: Shiri Barkan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketamine; Oral Ketamine in addition to oral midazolam	Drug: Ketamine; 5mg/kg as oral suspension
Placebo Comparator: Placebo; Normal saline (placebo) in addition to oral midazolam	Drug: Normal Saline; Normal Saline (placebo) in addition to Midazolam 0.5mg/kg as oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain score: Visual analog score (VAS)- by parent	participants will be followed for the duration of hospital stay, an expected average of 3 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain score: Visual analog score (VAS)- by a physician	while in the ED for about 3 hours

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Publications and helpful links

General Publications

• Barkan S, Breitbart R, Brenner-Zada G, Feldon M, Assa A, Toledano M, Berkovitch S, Shavit I, Kozer E. A double-blind, randomised, placebo-controlled trial of oral midazolam plus oral ketamine for sedation of children during laceration repair. Emerg Med J. 2014 Aug;31(8):649-53. doi: 10.1136/emermed-2012-202189. Epub 2013 May 18.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: September 19, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (Estimate): November 11, 2011

Study Record Updates

• Last Update Posted (Estimate): November 11, 2011
• Last Update Submitted That Met QC Criteria: November 9, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 22/11