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

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.

Study Overview

• Status: Unknown
• Conditions: Lacerations
• Intervention / Treatment: Drug: Experimental Arm: Ketamine; Drug: Midazolam - active comparator

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

Contacts and Locations

• Study Contact: Name: Eran Kozer, MD; Phone Number: 972-8-9779916; Email: erank@assaf.health.gov.il

Study Locations

• Israel
  • Be'er Ya'aqov, Israel
    • Recruiting
    • Assaf Harofeh Mc
    • Contact: Orit Rubinstein, MD; Phone Number: 972-8-9779916; Email: oritar78@gmail.com
    • Sub-Investigator: Orit Rubinstein, 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:

• 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
• American Society of Anesthesiologists (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
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ketamine; Oral ketamine	Drug: Experimental Arm: Ketamine; Oral Ketamine 5mg/kg Single dose; Other Names: Ketalar
ACTIVE_COMPARATOR: Midazolam; Oral Midazolam	Drug: Midazolam - active comparator; Oral midazolam - 0.7mg/kg single dose; Other Names: Dormicum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score: Visual analog score (VAS)- by a parent	A parent will assess the child's pain on a Visual analog scale	During the procedure - up to 1 hour
Number of patients requiring IV sedation	patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation	During the procedure - up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UMSS - by ED physician		During the procedure - up to 1 hour
• VAS by nurse		During the procedure - up to 1 hour
Time to reach UMSS > 2		up to 1 hour
• Procedure time		During the procedure - up to 1 hour
• Time from procedure to full recovery		While in the ED - estimated time around 2 hours
The occurrence of adverse effects during the ED stay	Significant adverse effects are defined as; Oxygen desaturation <92% or hypoventilation requiering ventilatory support; Need for hemodynamic support; Anaphylaxis; Seizures; Any adverse effects requiring patient admission	While in the ED - estimated time around 2 hours
• Patients and parents satisfaction assessed on VAS		While in the ED - estimated time around 2 hours

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ANTICIPATED): February 1, 2014
• Study Completion (ANTICIPATED): July 1, 2014

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: August 18, 2013
• First Posted (ESTIMATE): August 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 20, 2014
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Pediatrics; Sedation; Laceration
• 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; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Ketamine; Midazolam
• Other Study ID Numbers: 87/13