Oral Morphine Versus Ketamine in Pain Management

December 17, 2021 updated by: Mbarara University of Science and Technology

Oral Morphine Versus Rectal Ketamine in Pain Management During Burns Wound Dressing Changes in Paediatric Population at Mbarara Regional Referral Hospital: An Open Label Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Mbarara, Uganda, 00256
        • Mbarara Regional Referral Hospital
      • Mbarara, Uganda, 256
        • Mbarara Regional Referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP A
Group A will receive rectal ketamine(Ket)
Drug: GROUP A
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.
Other Names:
  • KETAMINE GROUP
Active Comparator: GROUP B
Group B will receive only traditional standard of care protocols.
Drug: GROUP B
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.
Other Names:
  • MORPHINE GROUP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAIN SCORES ON ORAL MORPHINE VERSUS KETAMINE ARM
Time Frame: 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
4 hours
DIFFERENCE IN THE INCIDENCE OF ADVERSE EFFECTS IN ORAL MORPHINE VERSUS KETAMINE ARM
Time Frame: 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.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mbarara University of Science and Technology

Investigators

  • Principal Investigator: ALICE G. ATAI, MbChB, Mbarara University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

November 3, 2021

Study Completion (Actual)

November 3, 2021

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

December 17, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

December 20, 2021

Last Update Submitted That Met QC Criteria

December 17, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/ANDREW

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain, Procedural

Clinical Trials on GROUP A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe