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

Phase 4

• Conditions: Pain, Postoperative
• Interventions: Drug: naproxen; Drug: placebo

• Registration Number: NCT00615875
• Lead Sponsor: Hamilton Health Sciences Corporation

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 pain medication requirements and contribute to improved pain management.

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 receives multimodal analgesia, including adjunctive medications (acetaminophen and naproxen/ketorolac) scheduled around the clock. When APS discontinues the epidural/pain pump, all adjunctive medications are discontinued and the patient is usually started on 'as needed' opiate or combination opiate (i.e. Tylenol#3) medications. On occasion, APS will write an order for an additional 48 hours of naproxen, but this practice has not been formally evaluated at this site. This randomized, placebo-controlled study proposes to evaluate this bridging strategy to see if regularly scheduled naproxen after discontinuation of other post-operative medications will affect the daily doses of opiate pain medications used, side effects of those opiate medications and pain scores of patients.

Study Timeline

• Status Verified: 2008-01
• Study First Submitted: 2008-02-01
• Study First Submitted QC: 2008-02-01
• Last Update Submitted: 2008-02-01
• Study First Posted: 2008-02-14
• Last Update Posted: 2008-02-14
• Study Start: 2008-03
• Primary Completion: 2008-05
• Study Completion: 2008-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	naproxen	-
P	placebo	-

Primary Outcome Measures

Name	Time	Method
cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)	daily

Secondary Outcome Measures

Name	Time	Method
patient reported pain scores	at least three times daily
side effects of study medication and opiate analgesia	at least three times daily

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada