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

NCT ID: NCT01925898

Last Updated: 2014-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-07-31

Brief 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.

Conditions

Lacerations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketamine

Oral ketamine

Group Type: EXPERIMENTAL

Experimental Arm: Ketamine

Intervention Type: DRUG

Oral Ketamine 5mg/kg Single dose

Midazolam

Oral Midazolam

Group Type: ACTIVE_COMPARATOR

Midazolam - active comparator

Intervention Type: DRUG

Oral midazolam - 0.7mg/kg single dose

Interventions

Midazolam - active comparator

Oral midazolam - 0.7mg/kg single dose

Intervention Type: DRUG

Experimental Arm: Ketamine

Oral Ketamine 5mg/kg Single dose

Intervention Type: DRUG

Other Intervention Names

Dormicum; Ketalar

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assaf Harofeh MC

Be’er Ya‘aqov, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Eran Kozer, MD

Role: CONTACT

erank@assaf.health.gov.il

972-8-9779916

Facility Contacts

Orit Rubinstein, MD

Role: primary

oritar78@gmail.com

972-8-9779916

Other Identifiers

87/13

Identifier Type: -

Identifier Source: org_study_id