Status:
UNKNOWN
Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether using an additional 48 hours of oral naproxen, after other post-operative pain medications have been stopped, will be effective in reducing opiate pai...
Detailed Description
At St. Joseph's Healthcare Hamilton, the Acute Pain Service (APS) is responsible for the immediate post-operative pain management of many surgical inpatients. While cared for by APS, the patient recei...
Eligibility Criteria
Inclusion
- undergone Head \& Neck and Thoracic surgery
- admitted to Chest, Head and Neck or Step-Down at St. Joseph's Healthcare
- pain management by APS (epidural/pain pump) including naproxen/ketorolac
- able to take oral medications (by mouth, feeding tube or NG tube)
- reasonably able to communicate in English and provide consent
Exclusion
- pre-existing chronic pain (morphine equivalent doses over 200mg/day in 5 days previous to surgery)
- recovering from cardiac, urological, orthopedic, laparoscopic or ambulatory surgery
- chronic NSAID therapy (daily for more than 3 weeks or high dose (over 81mg) ASA at least 4 days/week for more than 3 weeks)
- pregnancy, diagnosis of sepsis, history of stroke or transient ischemic attack, CHF (NYHA 3 or 4), allergy or contraindication to NSAIDS as defined by APS protocol
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00615875
Start Date
March 1 2008
End Date
June 1 2008
Last Update
February 14 2008
Active Locations (1)
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1
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6