Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial

• Status: Unknown status
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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 pain medication requirements and contribute to improved pain management.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Treatments: Naproxen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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