Oral Morphine Versus Ketamine in Pain Management

Ketamine

Brief Summary

The study will mainly focus on procedural pain management using oral morphine versus rectal ketamine during paediatric burn and wound dressing at Mbarara Regional Referral Hospital.

Intervention / Treatment

Rectal ketamine versus oral morphine in pain management in paediatric wound and burns
  • GROUP A (DRUG)
    Rectal Ketamine will be administered at 6 mg/kg and with a rectal nozzle it's infused through the rectum. The rectal ketamine will be administered after scoring pain just before the start of the procedure and then about 15 minutes later the procedure will start when the patient has achieved a nystagmus.
  • GROUP B (DRUG)
    The tradition standard protocols involve the use of 0.3mg/kg of oral morphine about an hour before the start of the procedure before the start of the procedure to allow for the onset of action of oral morphine for every single procedure in this arm.

Condition or Disease

  • Pain, Procedural

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 6 Months to 6 Years
    Enrollment: 44 (ACTUAL)
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Mar 01, 2021 ACTUAL
    Primary Completion: Nov 03, 2021 ACTUAL
    Completion Date: Nov 03, 2021 ACTUAL
    Study First Posted: Dec 20, 2021 ACTUAL
    Last Updated: Dec 17, 2021

    Sponsors / Collaborators

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

    Subjects will be randomly assigned to one of the two treatment groups A and B. Guardians of patients who are scheduled for burn wound care will sign written consent pre- operatively about procedural pain management. Group A will receive rectal ketamine while those in Group B will receive only traditional standard of care protocols.

    Participant Groups

    • Group A will receive rectal ketamine(Ket)

    • Group B will receive only traditional standard of care protocols.

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 6
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Pediatric patients between 6 months and 6-years old scheduled for a minimum of one procedure for burn wound dressing at the pediatric unit at Mbarara Regional Referral Hospital

    Exclusion Criteria:

    * Children with rectal or anal pathology,
    * Refusal to assent to participate or parental or guardian refusal to consent in the study
    * Children who require mechanical ventilation or already intubated in Intensive care unit
    * Those allergic to Ketamine or its constituents

    Primary Outcomes

    • The primary endpoint will be difference in pain scores on a Revised FLACC(Face, Leg, Activity, Cry, Consolability) scale in the two arms.The primary endpoint will be difference in pain scores on a Revised FLACC(Face, Leg, Activity, Cry, Consolability) scale in the two arms. Each category is scored on the 0-2 scale, which results in a total score of 0-10. 0: Relaxed and comfortable, 1-3 : Mild discomfort ,4-6 : Moderate pain, 7-10 : Severe discomfort or pain or both

    • Secondary endpoint will be the difference in the incidence of adverse effects a cross arms obtained from patient, nurse, and chart for DAIDS Adverse Event Grading Table 2014.

    More Details

    NCT Number: NCT05163366
    Other IDs: 2021/ANDREW
    Study URL: https://clinicaltrials.gov/study/NCT05163366
    Last updated: Sep 29, 2023