Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

Ketamine

Brief Summary

The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ED) compared to a group of patients who receive morphine alone for pain management. Patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be accomplished using morphine. Patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. Family members are contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.

Intervention / Treatment

  • Ketamine (DRUG)
    N/A
  • Morphine (DRUG)
    N/A

Condition or Disease

  • Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Years to 17 Years
    Enrollment: 77 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

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

    Clinical Trial Dates

    Start date: Dec 01, 2012
    Primary Completion: Jun 01, 2015 ACTUAL
    Completion Date: Jun 01, 2015 ACTUAL
    Study First Posted: Sep 27, 2013 ESTIMATED
    Results First Posted: Oct 16, 2017 ACTUAL
    Last Updated: Jun 05, 2018

    Sponsors / Collaborators

    Lead Sponsor: HealthPartners Institute
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Saint Paul, Minnesota, USA

    Participant Groups

    • Ketamine, single dose, 0.3 mg/kg, IV

    • Morphine, single dose, 0.05 mg/kg, IV

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 17
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Age: 3-17 years old
    * Condition (medical or trauma) requiring opioid pain management per standard of care
    * Need to establish an IV per standard of care
    * Treating physician agrees to manage the patient's pain with morphine following randomization.

    Exclusion Criteria:

    * Trauma Team Activation
    * Known allergy to ketamine
    * Family member unable/unavailable to provide informed consent
    * When appropriate, patient unwilling to provide assent
    * High suspicion of injury related to child abuse
    * Patient and/or family member is non-English speaking
    * Patient is incarcerated

    Primary Outcomes

    • All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.

    • Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form.

    Other Outcomes

    • FLACC scores were assessed on the patient using the FLACC scale (0-10) by the parent, treating RN/trained research assistant. * FLACC - Parents 30 Minutes Post dose * FLACC - Staff 30 Minutes Post dose Wong-Baker Faces scale is a self-assessment of pain Scale of 1-10 pain.

    More Details

    NCT Number: NCT01951963
    Other IDs: A12-158
    Study URL: https://clinicaltrials.gov/study/NCT01951963
    Last updated: Sep 29, 2023