Official Title: “Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

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.

Intervention(s) in this Clinical Trial

• Drug: naproxen
  • opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.
• Drug: placebo
  • opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Placebo Comparator: P

Primary Measures

• cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)
  • Time Frame: daily
    Safety Issue?: No

Secondary Measures

• patient reported pain scores
  • Time Frame: at least three times daily
    Safety Issue?: No
• side effects of study medication and opiate analgesia
  • Time Frame: at least three times daily
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hamilton Health Sciences

Overall Clinical Trial Officials and Contacts

Tuan Dinh, RPh Principal Investigator Hamilton Health Sciences  

Overall Contact: Victoria Luckham, BScPhm (905)522-1155 vluckham@stjoes.ca

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00615875

Study ID Number: 07-2936

ClinicalTrials.gov Identifier: NCT00615875

Health Authority: Canada: Ethics Review Committee