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Completed

NCT Number: NCT05163366

Oral Morphine Versus Ketamine in Pain Management

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.

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Key information

Conditions

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

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mbarara Regional Referral Hospital, Mbarara, Uganda

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: KETAMINE GROUP

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.

Other names: MORPHINE GROUP

Primary outcomes

  1. PAIN SCORES ON ORAL MORPHINE VERSUS KETAMINE ARM

    Time frame: 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

  2. DIFFERENCE IN THE INCIDENCE OF ADVERSE EFFECTS IN ORAL MORPHINE VERSUS KETAMINE ARM

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mbarara University of Science and Technology

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2021
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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