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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02514122 |
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Date of registration:
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31/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda
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Scientific title:
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Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda: a Randomized Control Trial |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02514122 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Rwanda
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Contacts
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Name:
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William Mckay, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Saskatchewan |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pain
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Post Operative Pain
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Intervention(s)
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Drug: Saline
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Drug: Ketamine
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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Hallucination
[Time Frame: From end of surgery until 60 hours postoperative.]
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Secondary ID(s)
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Bio# 14-193
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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