Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda

NCT02514122 | Completed Phase 2 Results DMC

• 1 other identifier: Bio# 14-193
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain as Measured on a 11-point Numerical Rating Scale

  Pain will be measured using an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable) units on a scale.

  The average of twice daily pain scores, from end of surgery until 60 hours postoperative.

Secondary Outcomes (1)

• Hallucination

  From end of surgery until 60 hours postoperative.

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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

Interventions

Ketamine DRUG

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.

Ketamine

Saline DRUG

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.

Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Saskatchewan: lead
• National University, Rwanda: collaborator

Study Sites (1)

University of Rwanda

Kigali, S7N 0W8, Rwanda

Location

Related Publications (1)

• 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.

  PMID: 29134517 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. William P. McKay
• Organization: University of Saskatchewan

bill.mckay@usask.ca

1 306 655 1202

Study Officials

• William Mckay, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FRCPC

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 3, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 9, 2018
• Results First Posted: November 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)