Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

• ClinicalTrials.gov Identifier: NCT02514122
• Recruitment Status: Completed
• First Posted: August 3, 2015
• Results First Posted: November 9, 2018
• Last Update Posted: November 9, 2018
• Sponsor: University of Saskatchewan
• Collaborator: National University, Rwanda
• Information provided by (Responsible Party): William McKay, University of Saskatchewan

Study Description

Brief Summary:

A randomized double blind control trial to investigate the safety and efficacy of subcutaneous ketamine for control of post operative pain in low resource settings.

Condition or disease	Intervention/treatment	Phase
Post Operative Pain; Pain	Drug: Ketamine; Drug: Saline	Phase 2; Phase 3

Detailed Description:

A randomized double blind control trial. All patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries at the Centre Hospitalier Universitaire de Kigali, Kigali, Rwanda will be invited to participate. Enrolled patients will receive subcutaneous ketamine (or placebo) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg. The primary outcome will be a reduction in mean Pain Scores using parametric statistical analysis to discriminate significance. Pain will be measured using an 11-point numerical rating scale. Secondary outcomes will be the presence of significant side effects. This trial is a partnership between the University of Saskatchewan and the National University of Rwanda with ethics approval from each institutions ethics board.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda: a Randomized Control Trial
• Study Start Date: June 2015
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ketamine; Participants will receive subcutaneous ketamine (1mg/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg.	Drug: Ketamine; Patients will receive a subcutaneous injection of ketamine (at a dose of 1mg/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.
Placebo Comparator: Saline; Participants will receive subcutaneous saline (0.02cc/kg) administered immediately after surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.	Drug: Saline; Patients will receive a subcutaneous injection of saline (at a dose of 0.02cc/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.

Outcome Measures

Primary Outcome Measures :

1. Postoperative Pain as Measured on a 11-point Numerical Rating Scale [ Time Frame: The average of twice daily pain scores, from end of surgery until 60 hours postoperative. ]
   Pain will be measured using an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable) units on a scale.

Secondary Outcome Measures :

1. Hallucination [ Time Frame: From end of surgery until 60 hours postoperative. ]
   Presence (or not) of hallucinations.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

- All patients undergoing upper abdominal, thoracic, gynecologic or orthopaedic surgeries during a one month period with expected post operative hospital admission

Exclusion Criteria:

• Allergy to Ketamine
• History of narcotic abuse or dependence
• Those patients for which decreased cognitive function is a barrier to accurate data collection

Contacts and Locations

Locations

Rwanda

University of Rwanda

Kigali, Rwanda, S7N 0W8

Sponsors and Collaborators

University of Saskatchewan

National University, Rwanda

Investigators

• Principal Investigator: William Mckay, MD; University of Saskatchewan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sacevich C, Semakuba B, McKay WP, Thakore S, Twagirumugabe T, Nyiligira J. Subcutaneous ketamine for postoperative pain relief in Rwanda: a randomized clinical trial. Can J Anaesth. 2018 Feb;65(2):170-177. doi: 10.1007/s12630-017-1009-7. Epub 2017 Nov 13.

• Responsible Party: William McKay, MD FRCPC, University of Saskatchewan
• ClinicalTrials.gov Identifier: NCT02514122
• Other Study ID Numbers: Bio# 14-193
• First Posted: August 3, 2015
• Results First Posted: November 9, 2018
• Last Update Posted: November 9, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: IPD will not be shared.

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Ketamine; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Central Nervous System Depressants; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action