Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients

Ketamine

Brief Summary

The purpose of this study is to determine if intranasal ketamine is equally as effective and safe as intramuscular ketamine for procedural sedation in pediatric patients.

Intervention / Treatment

  • Ketamine (DRUG)
    Intramuscular Ketamine

Condition or Disease

  • Sedation

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 2 Years to 17 Years
    Enrollment: 3 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: Jan 01, 2011
    Primary Completion: Jan 01, 2012 ACTUAL
    Completion Date: Jan 01, 2012 ACTUAL
    Study First Posted: Jul 27, 2010 ESTIMATED
    Results First Posted: Jul 02, 2017 ACTUAL
    Last Updated: Jun 03, 2017

    Sponsors / Collaborators

    Lead Sponsor: University of Iowa
    Responsible Party: N/A

    Location

    Iowa City, Iowa, USA

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: All
    Minimum Age: 2
    Maximum Age: 17
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * pediatric patients age 2 to 17 years old
    * have a laceration of 4 cm on the face or 7 cm on the remainder of the body
    * Require procedural sedation to repair the laceration

    Exclusion Criteria:

    * Patients with abnormal nasal physiology which would not allow for adequate medication delivery
    * Unable to have a guardian present to consent on their behalf
    * Allergy to ketamine
    * Significant cardiac history (myocardial ischemia, heart failure, arrhythmias)
    * Presenting with a head injury associated with possible intracranial hypertension
    * Pregnancy
    * Lacerations that require repair from a consult service

    Primary Outcomes

    • Minutes it takes until the patient is cooperative enough for the procedure

    More Details

    NCT Number: NCT01170247
    Other IDs: 201006786
    Study URL: https://clinicaltrials.gov/study/NCT01170247
    Last updated: Sep 29, 2023