Pain Clinical Trial
Official title:
Intraoperative Ketorolac Dose of 15 mg Versus the Standard 30 mg on Early Postoperative Pain After Spine Surgery: A Randomised, Blinded, Non-Inferiority Trial
The primary aim of this study is to show the non-inferiority of 15 mg intraoperative dose of ketorolac as compared to the standard 30 mg ketorolac by looking at the VAS scores 4 hours after an adult spine surgery.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients booked for 1-2 level spine laminectomies and/or decompression - Adult 18 - 65 years - Weight of 50 - 110 kg Exclusion Criteria: - Previous lumbar laminectomy - Current anticoagulant use with INR > 1.2 - Narcotic use > 4 weeks - Known allergy or sensitivity to NSAID or morphine - Renal insufficiency with creatinine >100 umol/L - Known liver disease - History of gastrointestinal bleeding - Pregnancy, history of bronchial asthma - NSAID use 2 days before surgery. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Score | To show the non-inferiority of 15 mg intraoperative dose of ketorolac as compared to the standard 30 mg ketorolac by looking at the VAS scores 4 hours after an adult spine surgery. Minimum clinically significant decrease in VAS pain score is 18 mm. | Four hours after surgery | No |
Secondary | Morphine Usage After Surgery | A 10 mg decrease in morphine use in 24 hours is considered clinically significant. | 8 hours and 24 hours after surgery | No |
Secondary | Morphine Adverse Effects | Presence of morphine-related adverse effects such as sedation, nausea, vomiting, respiratory depression, and pruritus. | First 24 hours | No |
Secondary | Postoperative Bleeding | Hemoglobin levels will be measured before surgery and 24 hours surgery. | 24 hours after surgery | No |
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