PainNCT01165814
Naproxen Versus Tramadol for Post Cesarean Pain Control
A study testing Naproxen Tramadol in people with Pain and Cesarean Section, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
Oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pain, Cesarean Section
- What is being tested?
- Naproxen Tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2006to Mar 2009
- Phase
- Interventional
- 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 Any age
- Women only
- Child, Adult, Older adult
Who may be able to join
- all patients after cesarean section
Who cannot join
- emergent CS
- hypersensitivity to drug
- drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Naproxen Versus Oral Tramadol for Analgesia After Cesarean Delivery - A Randomized Controlled Trial
Oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol.
- Conditions
- Pain, Cesarean Section
- Being tested
- Naproxen Tramadol
- Keywords
- Pain control after cesarean section
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen TramadolDrug
| Study group | Role | What they receive |
|---|---|---|
| Tramadol at fixed intervals | Active comparator | Not described Receives: Drug: Naproxen Tramadol |
| Tramadol on request | Active comparator | Not described Receives: Drug: Naproxen Tramadol |
| Naproxen at fixed intervals | Active comparator | Not described Receives: Drug: Naproxen Tramadol |
| Naproxen on request | Active comparator | Not described Receives: Drug: Naproxen Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Secondary outcomes (1)
Side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startAug 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165814
- Sponsor's protocol ID
- TRAMNAP
- Status last verified
- Jul 2010
- First submitted
- 18 Jul 2010
- Last updated
- 20 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Naproxen Versus Oral Tramadol for Analgesia After Cesarean Delivery - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01165814
- Acronym / sponsor ID
- TRAMNAP
- Conditions
- Pain, Cesarean Section
- Keywords
- Pain control after cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Aug 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 Jul 2010 (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.
Oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tramadol at fixed intervals | Active comparator | Drug: Naproxen Tramadol |
| Tramadol on request | Active comparator | Drug: Naproxen Tramadol |
| Naproxen at fixed intervals | Active comparator | Drug: Naproxen Tramadol |
| Naproxen on request | Active comparator | Drug: Naproxen Tramadol |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients after cesarean section
Key exclusion criteria (3 listed)
- emergent CS
- hypersensitivity to drug
- drug abuse
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 |
|---|---|---|
| Naproxen Tramadol | Drug | Naproxen at fixed intervals, Naproxen on request, Tramadol at fixed intervals, Tramadol on request |
Primary outcome
Pain Score
1 secondary outcome
Side effects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naproxen Tramadol in people with Pain and Cesarean Section, run by Bnai Zion Medical Center at 1 site in Israel.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jul 2010. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2010.