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Sponsored by: |
Hamilton Health Sciences |
---|---|
Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00615875 |
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 |
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 |
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
|
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:
Exclusion Criteria:
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, Ontario | |
St. Joseph's Healthcare Hamilton | |
Hamilton, Ontario, Canada, L8N 4A6 |
Principal Investigator: | Tuan Dinh, RPh | McMaster University |
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 |
naproxen acute pain postoperative pain |
thoracic surgery head and neck surgery opiate sparing |
Signs and Symptoms Naproxen Postoperative Complications Pain Pain, Postoperative |
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 |