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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: May 2008
Detailed Clinical Trial 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.
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
Outcome Measures for this Clinical Trial
Primary Measures
- cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)
- Time Frame: daily
Safety Issue?: No
- Time Frame: daily
Secondary Measures
- patient reported pain scores
- Time Frame: at least three times daily
Safety Issue?: No
- Time Frame: at least three times daily
- side effects of study medication and opiate analgesia
- Time Frame: at least three times daily
Safety Issue?: Yes
- Time Frame: at least three times daily
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Hamilton Health Sciences Corporation Other
Overall Clinical Trial Officials and Contacts
Tuan Dinh, RPh Principal Investigator St. Joseph's Healthcare Hamilton
Overall Contact: Victoria Luckham, BScPhm (905)522-1155 vluckham@stjoes.ca
Related Publications
References
Starck PL, Sherwood GD, Adams-McNeill J, Thomas EJ. Identifying and addressing medical errors in pain mismanagement. Jt Comm J Qual Improv. 2001 Apr;27(4):191-9. Review.
Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-40, table of contents.
Callesen T, Bech K, Kehlet H. Prospective study of chronic pain after groin hernia repair. Br J Surg. 1999 Dec;86(12):1528-31.
Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North America. 2005 Mar;23(1):185-202. Review.
Hartrick CT. Multimodal postoperative pain management. Am J Health Syst Pharm. 2004 Apr;61 Suppl 1:S4-10. Review.
Cepeda MS, Carr DB, Miranda N, Diaz A, Silva C, Morales O. Comparison of morphine, ketorolac, and their combination for postoperative pain: results from a large, randomized, double-blind trial. Anesthesiology. 2005 Dec;103(6):1225-32.
Richy F, Bruyere O, Ethgen O, Rabenda V, Bouvenot G, Audran M, Herrero-Beaumont G, Moore A, Eliakim R, Haim M, Reginster JY. Time dependent risk of gastrointestinal complications induced by non-steroidal anti-inflammatory drug use: a consensus statement using a meta-analytic approach. Ann Rheum Dis. 2004 Jul;63(7):759-66. Review.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00615875
