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

Pain, Postoperative Clinical Trial

— NAPS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00615875
• Other study ID #: 07-2936
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 1, 2008
• Last updated: February 1, 2008
• Start date: March 2008
• Est. completion date: June 2008

Study information

• Verified date: January 2008
• Source: McMaster University
• Contact: Victoria Luckham, BScPhm
• Phone: (905)522-1155
• Email: vluckham[@]stjoes.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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. — View Citation

Callesen T, Bech K, Kehlet H. Prospective study of chronic pain after groin hernia repair. Br J Surg. 1999 Dec;86(12):1528-31. — View Citation

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. — View Citation

Hartrick CT. Multimodal postoperative pain management. Am J Health Syst Pharm. 2004 Apr;61 Suppl 1:S4-10. Review. — View Citation

Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North America. 2005 Mar;23(1):185-202. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)		daily	No
Secondary	patient reported pain scores		at least three times daily	No
Secondary	side effects of study medication and opiate analgesia		at least three times daily	Yes