Pain, Postoperative
Conditions
Keywords
naproxen, acute pain, postoperative pain, thoracic surgery, head and neck surgery, opiate sparing
Brief summary
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
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.
Interventions
DRUGnaproxen
opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.
DRUGplacebo
opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR) | daily |
Secondary
| Measure | Time frame |
|---|---|
| patient reported pain scores | at least three times daily |
| side effects of study medication and opiate analgesia | at least three times daily |
Countries
Canada
Contacts
Primary ContactVictoria Luckham, BScPhm
Backup ContactTuan Dinh, RPh
Outcome results
None listed