Pain, PostoperativePhase 4NAPSNCT00615875
Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
A Phase 4 study testing naproxen in people with Pain, Postoperative, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- naproxen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Jun 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Victoria Luckham, BScPhm
About this study
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- naproxen, placebo
- Keywords
- naproxen, acute pain, postoperative pain, thoracic surgery, head and neck surgery, opiate sparing
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naproxenDrug
Also called Naprosyn suspension (Roche)
opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice.
placeboDrug
opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: naproxen |
| P | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)
Measured: daily
Secondary outcomes (2)
patient reported pain scores
Measured: at least three times daily
side effects of study medication and opiate analgesia
Measured: at least three times daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Tuan Dinh, RPh, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615875
- Sponsor's protocol ID
- 07-2936
- Acronym
- NAPS
- Status last verified
- Jan 2008
- First submitted
- 1 Feb 2008
- Last updated
- 14 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11293836Apfelbaum 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.
PubMed 12873949Callesen 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.
PubMed 10594500Joshi 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.
PubMed 15763418Hartrick 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.
PubMed 15119755Cepeda 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.
PubMed 16306736Richy 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.
PubMed 15194568
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00615875
- Acronym / sponsor ID
- NAPS / 07-2936
- Conditions
- Pain, Postoperative
- Keywords
- naproxen, acute pain, postoperative pain, thoracic surgery, head and neck surgery, opiate sparing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 14 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: naproxen |
| P | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naproxenAlso: Naprosyn suspension (Roche)opaque pale orange suspension: 20mL q12h x 4 doses mixed in juice. | Drug | A |
| placeboopaque pale orange suspension: 20mL q12h x 4 doses mixed in juice | Drug | P |
Primary outcome
cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR)
Time frame: daily
2 secondary outcomes
patient reported pain scores
Time frame: at least three times daily
side effects of study medication and opiate analgesia
Time frame: at least three times daily
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2008.
- Background: PubMed 11293836Starck 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.
- Background: PubMed 12873949Apfelbaum 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.
- Background: PubMed 10594500Callesen 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.
- Background: PubMed 15763418Joshi 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.
- Background: PubMed 15119755Hartrick 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.
- Background: PubMed 16306736Cepeda 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.
- Background: PubMed 15194568Richy 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.
Related trials for Pain, Postoperative
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuan Dinh, RPh principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing naproxen in people with Pain, Postoperative, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria Luckham, BScPhm ((905)522-1155 ext. 33808, vluckham@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative opiate dose administered, as recorded on the computerized medication administration record (CMAR) (time frame: daily). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00615875, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2008.