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

This study is not yet open for participant recruitment.
Verified by Hamilton Health Sciences, January 2008

Sponsored by: Hamilton Health Sciences
Information provided by: Hamilton Health Sciences
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

ChemIDplus related topics:   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 Hamilton Health Sciences:

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     Not yet recruiting
      Hamilton, Ontario, Canada, L8N 4A6
      Principal Investigator: Victoria Luckham, BScPhm            

Sponsors and Collaborators
Hamilton Health Sciences

Investigators
Principal Investigator:     Tuan Dinh, RPh     Hamilton Health Sciences    
  More Information

Publications:

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

Keywords provided by Hamilton Health Sciences:
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 August 20, 2008




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