Oral Morphine Versus Ketamine in Pain Management

Pain, Procedural Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05163366
• Other study ID #: 2021/ANDREW
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2021
• Est. completion date: November 3, 2021

Study information

• Verified date: April 2021
• Source: Mbarara University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Procedural

Intervention

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.
• 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.

Locations

Country	Name	City	State
Uganda	Mbarara Regional Referral Hospital	Mbarara
Uganda	Mbarara Regional Referral Hospital	Mbarara

Sponsors (1)

Lead Sponsor	Collaborator
Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 hours
Primary	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.	4 hours