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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-06-30

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.

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

naproxen

Intervention Type DRUG

opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.

P

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice

Interventions

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naproxen

opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.

Intervention Type DRUG

placebo

opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice

Intervention Type DRUG

Other Intervention Names

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Naprosyn suspension (Roche)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No