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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.
Study NCT00615875   Information provided by McMaster University
First Received: February 1, 2008   No Changes Posted

February 1, 2008
February 1, 2008
March 2008
May 2008   (final data collection date for primary outcome measure)
cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR) [ Time Frame: daily ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
 
Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Pain, Postoperative
  • Drug: naproxen
  • Drug: placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
24
June 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Victoria Luckham, BScPhm (905)522-1155 ext 33808 vluckham@stjoes.ca
Contact: Tuan Dinh, RPh (905)522-1155 ext 33808 tdinh@stjoes.ca
Canada
 
NCT00615875
Tuan Dinh, Pharmacy Department, St. Joseph's Healthcare Hamilton
07-2936
Hamilton Health Sciences
 
Principal Investigator: Tuan Dinh, RPh McMaster University
McMaster University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP