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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: naproxen
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: naproxen<br>* opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.<br>* Other names: Naprosyn suspension (Roche);|
| Placebo Comparator: P<br> | Drug: placebo<br>* opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR) |  | daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient reported pain scores |  | at least three times daily | 
| side effects of study medication and opiate analgesia |  | at least three times daily | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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naproxen, acute pain, postoperative pain, thoracic surgery, head and neck surgery, opiate sparing