Oral Morphine Versus Ketamine in Pain Management

Sponsor

Mbarara University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT05163366

Collaborator

(none)

Enrollment

Locations

Arms

8.1

Actual Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Procedural	Drug: GROUP A Drug: GROUP B	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Rectal ketamine versus oral morphine in pain management in paediatric wound and burnsRectal ketamine versus oral morphine in pain management in paediatric wound and burns

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Nov 3, 2021

Actual Study Completion Date :

Nov 3, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 6 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mbarara Regional Referral Hospital	Mbarara		Uganda	00256
2	Mbarara Regional Referral Hospital	Mbarara		Uganda	256

Sponsors and Collaborators

Mbarara University of Science and Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mbarara University of Science and Technology

ClinicalTrials.gov Identifier:

NCT05163366

Other Study ID Numbers:

2021/ANDREW

First Posted:

Dec 20, 2021

Last Update Posted:

Dec 20, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Procedural

Ketamine

Morphine

Study Results

No Results Posted as of Dec 20, 2021