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

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00615875

Purpose

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.

Condition	Intervention	Phase
Pain, Postoperative	Drug: naproxen Drug: placebo	Phase IV

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial

Further study details as provided by McMaster University:

Primary Outcome Measures:

cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR) [ Time Frame: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	24
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: naproxen opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.
P: Placebo Comparator	Drug: placebo opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615875

Contacts

Contact: Victoria Luckham, BScPhm	(905)522-1155 ext 33808	vluckham@stjoes.ca
Contact: Tuan Dinh, RPh	(905)522-1155 ext 33808	tdinh@stjoes.ca

Locations

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

Sponsors and Collaborators

Hamilton Health Sciences

Investigators

Principal Investigator:

Tuan Dinh, RPh

McMaster University

More Information

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.

Responsible Party:	Pharmacy Department, St. Joseph's Healthcare Hamilton ( Tuan Dinh )
Study ID Numbers:	07-2936
Study First Received:	February 1, 2008
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00615875
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

naproxen
acute pain
postoperative pain

thoracic surgery
head and neck surgery
opiate sparing

Study placed in the following topic categories:

Signs and Symptoms
Naproxen
Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Pharmacologic Actions
Pathologic Processes

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009