| February 1, 2008 |
| February 1, 2008 |
| March 2008 |
| May 2008 (final data collection date for primary outcome measure) |
| cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR) [ Time Frame: daily ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
- patient reported pain scores [ Time Frame: at least three times daily ] [ Designated as safety issue: No ]
- side effects of study medication and opiate analgesia [ Time Frame: at least three times daily ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial |
| 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. |
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. |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Pain, Postoperative |
- Drug: naproxen
- Drug: placebo
|
| |
- 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.
|
| |
| Not yet recruiting |
| 24 |
| June 2008 |
| May 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
|
|
| Canada |
| |
| NCT00615875 |
| Tuan Dinh, Pharmacy Department, St. Joseph's Healthcare Hamilton |
| 07-2936 |
| Hamilton Health Sciences |
|
| Principal Investigator: |
Tuan Dinh, RPh |
McMaster University |
|
|
| McMaster University |
| January 2008 |