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Oral Morphine Versus Ketamine in Pain Management

Primary Purpose

Pain, Procedural

Status
Completed
Phase
Phase 3
Locations
Uganda
Study Type
Interventional
Intervention
GROUP A
GROUP B
Sponsored by
Mbarara University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Procedural

Eligibility Criteria

6 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mbarara Regional Referral Hospital
  • Mbarara Regional Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GROUP A

GROUP B

Arm Description

Group A will receive rectal ketamine(Ket)

Group B will receive only traditional standard of care protocols.

Outcomes

Primary Outcome Measures

PAIN SCORES ON ORAL MORPHINE VERSUS KETAMINE ARM
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
DIFFERENCE IN THE INCIDENCE OF ADVERSE EFFECTS IN ORAL MORPHINE VERSUS KETAMINE ARM
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.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2021
Last Updated
December 17, 2021
Sponsor
Mbarara University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05163366
Brief Title
Oral Morphine Versus Ketamine in Pain Management
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
November 3, 2021 (Actual)
Study Completion Date
November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mbarara University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Rectal ketamine versus oral morphine in pain management in paediatric wound and burns
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP A
Arm Type
Experimental
Arm Description
Group A will receive rectal ketamine(Ket)
Arm Title
GROUP B
Arm Type
Active Comparator
Arm Description
Group B will receive only traditional standard of care protocols.
Intervention Type
Drug
Intervention Name(s)
GROUP A
Other Intervention Name(s)
KETAMINE GROUP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
GROUP B
Other Intervention Name(s)
MORPHINE GROUP
Intervention Description
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.
Primary Outcome Measure Information:
Title
PAIN SCORES ON ORAL MORPHINE VERSUS KETAMINE ARM
Description
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
Time Frame
4 hours
Title
DIFFERENCE IN THE INCIDENCE OF ADVERSE EFFECTS IN ORAL MORPHINE VERSUS KETAMINE ARM
Description
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.
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALICE G. ATAI, MbChB
Organizational Affiliation
Mbarara University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara Regional Referral Hospital
City
Mbarara
ZIP/Postal Code
00256
Country
Uganda
Facility Name
Mbarara Regional Referral Hospital
City
Mbarara
ZIP/Postal Code
256
Country
Uganda

12. IPD Sharing Statement

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Oral Morphine Versus Ketamine in Pain Management

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