Study of Whether 15 mg Dose of Ketorolac IV is as Effective as a 30 mg Dose.
Intraoperative Ketorolac Dose of 15 mg Versus the Standard 30 mg on Early Postoperative Pain After Spine Surgery: A Randomised, Blinded, Non-Inferiority Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 27, 2010
CompletedFirst Posted
Study publicly available on registry
October 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 29, 2010
October 1, 2010
1 year
October 27, 2010
October 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Morphine Usage After Surgery
8 hours and 24 hours after surgery
Morphine Adverse Effects
First 24 hours
Postoperative Bleeding
24 hours after surgery
Study Arms (2)
15 mg ketorolac IV
ACTIVE COMPARATOR30 mg ketorolac IV
ACTIVE COMPARATORInterventions
15 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
Eligibility Criteria
You may qualify if:
- Patients booked for 1-2 level spine laminectomies and/or decompression
- Adult 18 - 65 years
- Weight of 50 - 110 kg
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaylene Duttchen, MD
University of Calgary - Department of Anesthesia
- PRINCIPAL INVESTIGATOR
Melinda Davis, MD
University of Calgary - Department of Anesthesia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 27, 2010
First Posted
October 29, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 29, 2010
Record last verified: 2010-10