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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02514122
Other study ID # Bio# 14-193
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date June 2015
Est. completion date July 2015

Study information

Verified date November 2018
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Rwanda University of Rwanda Kigali

Sponsors (2)

Lead Sponsor Collaborator
University of Saskatchewan National University, Rwanda

Country where clinical trial is conducted

Rwanda, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Hallucination Presence (or not) of hallucinations. From end of surgery until 60 hours postoperative.
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