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

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
naproxen
placebo
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring naproxen, acute pain, postoperative pain, thoracic surgery, head and neck surgery, opiate sparing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

P

Arm Description

Outcomes

Primary Outcome Measures

cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)

Secondary Outcome Measures

patient reported pain scores
side effects of study medication and opiate analgesia

Full Information

First Posted
February 1, 2008
Last Updated
February 1, 2008
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00615875
Brief Title
Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
Acronym
NAPS
Official Title
Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
May 2008 (Anticipated)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
naproxen, acute pain, postoperative pain, thoracic surgery, head and neck surgery, opiate sparing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
P
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
naproxen
Other Intervention Name(s)
Naprosyn suspension (Roche)
Intervention Description
opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice
Primary Outcome Measure Information:
Title
cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)
Time Frame
daily
Secondary Outcome Measure Information:
Title
patient reported pain scores
Time Frame
at least three times daily
Title
side effects of study medication and opiate analgesia
Time Frame
at least three times daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Luckham, BScPhm
Phone
(905)522-1155
Ext
33808
Email
vluckham@stjoes.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Tuan Dinh, RPh
Phone
(905)522-1155
Ext
33808
Email
tdinh@stjoes.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuan Dinh, RPh
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Luckham, BScPhm

12. IPD Sharing Statement

Citations:
PubMed Identifier
11293836
Citation
Starck PL, Sherwood GD, Adams-McNeill J, Thomas EJ. Identifying and addressing medical errors in pain mismanagement. Jt Comm J Qual Improv. 2001 Apr;27(4):191-9. doi: 10.1016/s1070-3241(01)27017-5.
Results Reference
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PubMed Identifier
12873949
Citation
Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
Results Reference
background
PubMed Identifier
10594500
Citation
Callesen T, Bech K, Kehlet H. Prospective study of chronic pain after groin hernia repair. Br J Surg. 1999 Dec;86(12):1528-31. doi: 10.1046/j.1365-2168.1999.01320.x.
Results Reference
background
PubMed Identifier
15763418
Citation
Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.
Results Reference
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PubMed Identifier
15119755
Citation
Hartrick CT. Multimodal postoperative pain management. Am J Health Syst Pharm. 2004 Apr;61 Suppl 1:S4-10. doi: 10.1093/ajhp/61.suppl_1.S4.
Results Reference
background
PubMed Identifier
16306736
Citation
Cepeda MS, Carr DB, Miranda N, Diaz A, Silva C, Morales O. Comparison of morphine, ketorolac, and their combination for postoperative pain: results from a large, randomized, double-blind trial. Anesthesiology. 2005 Dec;103(6):1225-32. doi: 10.1097/00000542-200512000-00018.
Results Reference
background
PubMed Identifier
15194568
Citation
Richy F, Bruyere O, Ethgen O, Rabenda V, Bouvenot G, Audran M, Herrero-Beaumont G, Moore A, Eliakim R, Haim M, Reginster JY. Time dependent risk of gastrointestinal complications induced by non-steroidal anti-inflammatory drug use: a consensus statement using a meta-analytic approach. Ann Rheum Dis. 2004 Jul;63(7):759-66. doi: 10.1136/ard.2003.015925.
Results Reference
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Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial

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