Oral Morphine Versus Ketamine in Pain Management

Phase 3

Completed

• Conditions: Pain, Procedural
• Interventions: Drug: GROUP A; Drug: GROUP B

• Registration Number: NCT05163366
• Lead Sponsor: Mbarara University of Science and Technology

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-22
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03
• Study First Submitted QC: 2021-12-17
• Last Update Submitted: 2021-12-17
• Study First Posted: 2021-12-20
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP A	GROUP A	Group A will receive rectal ketamine(Ket)
GROUP B	GROUP B	Group B will receive only traditional standard of care protocols.

Primary Outcome Measures

Name	Time	Method
DIFFERENCE IN THE INCIDENCE OF ADVERSE EFFECTS IN ORAL MORPHINE VERSUS KETAMINE ARM	4 hours	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.
PAIN SCORES ON ORAL MORPHINE VERSUS KETAMINE ARM	4 hours	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

Trial Locations

Locations (1)

Mbarara Regional Referral Hospital; 🇺🇬 Mbarara, Uganda