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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by McMaster University.
Recruitment status was  Not yet recruiting
Information provided by:
McMaster University Identifier:
First received: February 1, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial

Resource links provided by NLM:

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
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

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00615875

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

Canada, Ontario
St. Joseph's Healthcare Hamilton Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Principal Investigator: Victoria Luckham, BScPhm         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Principal Investigator: Tuan Dinh, RPh St. Joseph's Healthcare Hamilton
  More Information

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

Keywords provided by McMaster University:
acute pain
postoperative pain
thoracic surgery
head and neck surgery
opiate sparing

Additional relevant MeSH terms:
Acute Pain
Pain, Postoperative
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016