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

NCT00615875 | Unknown Phase 4

• 1 other identifier: 07-2936
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

naproxen; acute pain; postoperative pain; thoracic surgery; head and neck surgery; opiate sparing

Outcome Measures

Primary Outcomes (1)

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

  daily

Secondary Outcomes (2)

• patient reported pain scores

  at least three times daily

• side effects of study medication and opiate analgesia

  at least three times daily

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: naproxen

P

PLACEBO COMPARATOR

Drug: placebo

Interventions

naproxen DRUG

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

Also known as: Naprosyn suspension (Roche)

A

placebo DRUG

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

P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (7)

• 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.

  PMID: 11293836 BACKGROUND

• 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.

  PMID: 12873949 BACKGROUND

• 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.

  PMID: 10594500 BACKGROUND

• 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.

  PMID: 15763418 BACKGROUND

• 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.

  PMID: 15119755 BACKGROUND

• 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.

  PMID: 16306736 BACKGROUND

• 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.

  PMID: 15194568 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Tuan Dinh, RPh

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Luckham, BScPhm

CONTACT

(905)522-1155; vluckham@stjoes.ca

Tuan Dinh, RPh

CONTACT

(905)522-1155; tdinh@stjoes.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 14, 2008

Record last verified: 2008-01

Locations

CA (1)