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

Condition(s) targeted: Pain, Postoperative

Intervention: naproxen (Drug); placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Hamilton Health Sciences

Official(s) and/or principal investigator(s):
Tuan Dinh, RPh, Principal Investigator, Affiliation: McMaster University

Overall contact:
Victoria Luckham, BScPhm, Phone: (905)522-1155, Ext: 33808, Email: vluckham@stjoes.ca

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.

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

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

Primary outcome: cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)

Secondary outcome:

patient reported pain scores

side effects of study medication and opiate analgesia

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Victoria Luckham, BScPhm, Phone: (905)522-1155, Ext: 33808, Email: vluckham@stjoes.ca

St. Joseph's Healthcare Hamilton, Hamilton, Ontario L8N 4A6, Canada

Related publications:

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.

Starting date: March 2008
Ending date: June 2008
Last updated: February 1, 2008