Effect of Celecoxib on Transitional Pain After Outpatient Surgery
Overview[ - collapse ][ - ]
| Purpose | 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 |
|---|---|
| Condition | Pain |
| Intervention | Drug: celebrex Drug: placebo |
| Phase | Phase 4 |
| Sponsor | Lawson Health Research Institute |
| Responsible Party | Lawson Health Research Institute |
| ClinicalTrials.gov Identifier | NCT00664690 |
| First Received | April 18, 2008 |
| Last Updated | April 22, 2008 |
| Last verified | April 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 18, 2008 |
|---|---|
| Last Updated Date | April 22, 2008 |
| Start Date | July 2004 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | visual analogue score for pain [Time Frame: post-op period] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | severity of nausea [Time Frame: post-op period] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Celecoxib on Transitional Pain After Outpatient Surgery |
|---|---|
| Official Title | Effect of Celecoxib on Transitional Pain After Outpatient Surgery |
| Brief Summary | 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 |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Pain |
| Intervention | Drug: celebrex 400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop Drug: placebo placebo given preop and BID postop |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 60 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | December 2008 |
| Eligibility Criteria | 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 | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Ngozi Imasogie, MD 519-646-6000 nimasog@uwo.ca |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00664690 |
|---|---|
| Other Study ID Numbers | R-04-309 |
| Has Data Monitoring Committee | No |
| Information Provided By | Lawson Health Research Institute |
| Study Sponsor | Lawson Health Research Institute |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Ngozi Imasogie, MD Lawson Health Research Institute |
| Verification Date | April 2008 |
Locations[ + expand ][ + ]
| St. Joseph's Health Care | London, Ontario, Canada, N Principal Investigator: Ngozi Imasogie, MDRecruiting |
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