Effect of Celecoxib on Transitional Pain After Outpatient Surgery
Sixty adults having shoulder and forearm surgery will receive either placebo or celebrex started preoperatively and continued for 3 days. Rescue medications required as well as pain scores will be assessed using a patient diary to evaluate the effect of celebrex in controlling transitional...
Brief Summary
Official Title: “Effect of Celecoxib on Transitional Pain After Outpatient Surgery”
Sixty adults having shoulder and forearm surgery will receive either placebo or celebrex started preoperatively and continued for 3 days. Rescue medications required as well as pain scores will be assessed using a patient diary to evaluate the effect of celebrex in controlling transitional pain
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: December 2008
Intervention(s) in this Clinical Trial
- Drug: celebrex
- 400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop
- Drug: placebo
- placebo given preop and BID postop
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- celebrex
- Placebo Comparator: 2
- placebo
Outcome Measures for this Clinical Trial
Primary Measures
- visual analogue score for pain
- Time Frame: post-op period
Safety Issue?: No
- Time Frame: post-op period
Secondary Measures
- severity of nausea
- Time Frame: post-op period
Safety Issue?: No
- Time Frame: post-op period
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients scheduled for elective ambulatory surgery of the shoulder
- ASA I - III
- Able to read English
- Male or female
Exclusion Criteria:
- Allergy to local anesthetic, Cox2, sulpha drug, acetaminophen or oxycodone
- Women who are pregnant or lactating and women of childbearing age and not following acceptable contraceptive precautions
- Any major medical or psychiatric problem
- Those with a known history of narcotic dependence, abuse or chronic narcotic intake
- Patients with known history of peptic ulcer or GI bleeding in the past, ulcers, congestive heart failure, angina or previous heart attack, coagulation problems, venous thrombosis, kidney or liver disease or strokes
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Lawson Health Research Institute Other
Overall Clinical Trial Officials and Contacts
Ngozi Imasogie, MD Principal Investigator Lawson Health Research Institute
Overall Contact: Ngozi Imasogie, MD 519-646-6000 nimasog@uwo.ca
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664690
Study ID Number: R-04-309
ClinicalTrials.gov Identifier: NCT00664690
Health Authority: Canada: Ethics Review Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00664690
