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

NCT01925898 | Unknown Phase 4

• 1 other identifier: 87/13
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Laceration; Sedation; Pediatrics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (2)

Ketamine

EXPERIMENTAL

Oral ketamine

Drug: Experimental Arm: Ketamine

Midazolam

ACTIVE COMPARATOR

Oral Midazolam

Drug: Midazolam - active comparator

Interventions

Midazolam - active comparator DRUG

Oral midazolam - 0.7mg/kg single dose

Also known as: Dormicum

Midazolam

Experimental Arm: Ketamine DRUG

Oral Ketamine 5mg/kg Single dose

Also known as: Ketalar

Ketamine

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Any child with laceration requiring sedation

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofeh MC

Be’er Ya‘aqov, Israel

RECRUITING

MeSH Terms

Conditions

Lacerations

Interventions

Midazolam; Ketamine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Eran Kozer, MD

CONTACT

972-8-9779916; erank@assaf.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: August 20, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 22, 2014

Record last verified: 2013-08

Locations

IL (1)