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

Ketamine

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.

Intervention / Treatment

  • Midazolam - active comparator (DRUG)
    Oral midazolam - 0.7mg/kg single dose
  • Experimental Arm: Ketamine (DRUG)
    Oral Ketamine 5mg/kg Single dose

Condition or Disease

  • Lacerations

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 1 Year to 10 Years
    Enrollment: 60 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2013
    Primary Completion: Feb 01, 2014 ESTIMATED
    Completion Date: Jul 01, 2014 ESTIMATED
    Study First Posted: Aug 20, 2013 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 20, 2014

    Sponsors / Collaborators

    Lead Sponsor: Assaf-Harofeh Medical Center
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Be'er Ya'aqov, Israel

    Participant Groups

    • Oral ketamine

    • Oral Midazolam

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 10
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • A parent will assess the child's pain on a Visual analog scale

    • patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation

    Secondary Outcomes
    • 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

    • Significant adverse effects are defined as 1. Oxygen desaturation \<92% or hypoventilation requiering ventilatory support 2. Need for hemodynamic support 3. Anaphylaxis 4. Seizures 5. Any adverse effects requiring patient admission

    • • Patients and parents satisfaction assessed on VAS While in the ED - estimated time around 2 hours

    More Details

    NCT Number: NCT01925898
    Other IDs: 87/13
    Study URL: https://clinicaltrials.gov/study/NCT01925898
    Last updated: Sep 29, 2023