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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615875
Recruitment Status : Unknown
Verified January 2008 by McMaster University.
Recruitment status was:  Not yet recruiting
First Posted : February 14, 2008
Last Update Posted : February 14, 2008
Information provided by:
McMaster University

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: naproxen Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
Study Start Date : March 2008
Estimated Primary Completion Date : May 2008
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: A Drug: naproxen
opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.
Other Name: Naprosyn suspension (Roche)

Placebo Comparator: P Drug: placebo
opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice

Primary Outcome Measures :
  1. cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR) [ Time Frame: daily ]

Secondary Outcome Measures :
  1. patient reported pain scores [ Time Frame: at least three times daily ]
  2. side effects of study medication and opiate analgesia [ Time Frame: at least three times daily ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615875

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Contact: Victoria Luckham, BScPhm (905)522-1155 ext 33808
Contact: Tuan Dinh, RPh (905)522-1155 ext 33808

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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Principal Investigator: Victoria Luckham, BScPhm         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
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Principal Investigator: Tuan Dinh, RPh St. Joseph's Healthcare Hamilton

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Responsible Party: Tuan Dinh, Pharmacy Department, St. Joseph's Healthcare Hamilton Identifier: NCT00615875    
Other Study ID Numbers: 07-2936
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: February 14, 2008
Last Verified: January 2008
Keywords provided by McMaster University:
acute pain
postoperative pain
thoracic surgery
head and neck surgery
opiate sparing
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action