Oral Morphine Versus Ketamine in Pain Management

NCT05163366 | Completed Phase 3

• 1 other identifier: 2021/ANDREW
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain, Procedural

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

GROUP A

EXPERIMENTAL

Group A will receive rectal ketamine(Ket)

Drug: GROUP A

GROUP B

ACTIVE COMPARATOR

Group B will receive only traditional standard of care protocols.

Drug: GROUP B

Interventions

GROUP A DRUG

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.

Also known as: KETAMINE GROUP

GROUP A

GROUP B DRUG

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.

Also known as: MORPHINE GROUP

GROUP B

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead

Study Sites (2)

Mbarara Regional Referral Hospital

Mbarara, 00256, Uganda

Location

Mbarara Regional Referral Hospital

Mbarara, 256, Uganda

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ALICE G. ATAI, MbChB

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Rectal ketamine versus oral morphine in pain management in paediatric wound and burns

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: December 20, 2021
• Study Start: March 1, 2021
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: December 20, 2021

Record last verified: 2021-04

Locations

UG (2)