Oral Morphine Versus Ketamine in Pain Management

Mbarara University of Science and Technology44 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain, Procedural

Interventions

GROUP ADRUG

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 BDRUG

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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Mbarara Regional Referral Hospital

Mbarara, Uganda

Mbarara Regional Referral Hospital

Mbarara, Uganda

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 4 hours

Data from ClinicalTrials.gov

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