A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.
Information source: Assaf-Harofeh Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lacerations
Intervention: Midazolam - active comparator (Drug); Experimental Arm: Ketamine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Assaf-Harofeh Medical Center Overall contact: Eran Kozer, MD, Phone: 972-8-9779916, Email: erank@assaf.health.gov.il
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.
Clinical Details
Official title: A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain score: Visual analog score (VAS)- by a parentNumber of patients requiring IV sedation
Secondary outcome: UMSS - by ED physician• VAS by nurse Time to reach UMSS > 2 • Procedure time • Time from procedure to full recovery The occurrence of adverse effects during the ED stay • Patients and parents satisfaction assessed on VAS
Eligibility
Minimum age: 1 Year.
Maximum age: 10 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Eran Kozer, MD, Phone: 972-8-9779916, Email: erank@assaf.health.gov.il
Assaf Harofeh MC, Be'er Ya`aqov, Israel; Recruiting Orit Rubinstein, MD, Phone: 972-8-9779916, Email: oritar78@gmail.com Orit Rubinstein, MD, Sub-Investigator
Additional Information
Starting date: August 2013
Last updated: January 20, 2014
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