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

Hamilton Health Sciences (HHS)

Status and phase

Unknown

Phase 4

Conditions

Pain, Postoperative

Treatments

Drug: naproxen

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00615875

07-2936

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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