Clinical trial NCT00615875: Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
Official title: Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: naproxen
acute pain
postoperative pain
thoracic surgery
head and neck surgery
opiate sparing
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)
timeFrame: daily
Secondary outcomes:
measure: patient reported pain scores
timeFrame: at least three times daily
measure: side effects of study medication and opiate analgesia
timeFrame: at least three times daily
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Tuan Dinh, RPh
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
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citation: Hartrick CT. Multimodal postoperative pain management. Am J Health Syst Pharm. 2004 Apr;61 Suppl 1:S4-10. doi: 10.1093/ajhp/61.suppl_1.S4.
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. doi: 10.1097/00000542-200512000-00018.
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