Abortion,InducedNCT00361686
Comparison of Tramadol vs Remifentanyl Patient Controlled Analgesia for Second Trimester Abortions
A study testing tramadol, remifentanyl and patient contolled analgesia in people with Abortion,Induced, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Patients undergoing second trimester abortions will recieve either patient controlled analgesia with either remifentanyl or tramadol for pain alleviation. We beleive both to be equally effective for pain alleviation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion,Induced
- What is being tested?
- tramadol, remifentanyl and patient contolled analgesia
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2006to Jan 2007
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman undergoing 2nd trimester abortion -
Who cannot join
- Seizure disorder
- * Psychiatric disorder
- Inability to recieve patient controlled analgesia
- Allergy to tramadol or remifentanyl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Study Comparing Patient Controlled Analgesia With Tramadol vs. Remifentanyl for Women Undergoing 2nd Trimester Abortions
Patients undergoing second trimester abortions will recieve either patient controlled analgesia with either remifentanyl or tramadol for pain alleviation.
We beleive both to be equally effective for pain alleviation.
Read the detailed description
Women undergoing second trimester abortions will recieve patient controlled analgesia eith either tramadol or remifentanyl.
Patients will not know what they are recieving.
Patients in the tramadol goup will get a loading dose of tramadol and metocloparamide while the women in the remifentanyl group will be given a loading placebo.
Women will then be attached to one of the two patinet controlled analgesia protocols.
Throughout their laboring process they will be monitored for blood pressure, pulse, breathing rate, sedation score and nausea.
Additional medicatyion will be given for nausea.
If woman are still in pain the patient controlled analgesia settings will be set to deliver a higher dose. If the woman remains in pain, she will be given an additional per os medication.If this still does not alleviate pain, the option of epidural analgesia will be offered.
- Conditions
- Abortion,Induced
- Being tested
- tramadol, remifentanyl, patient contolled analgesia
- Keywords
- tramadol, remifentanyl, patient controlled analgesia, abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tramadolDrug
remifentanylDrug
patient contolled analgesiaDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction
VAS scores
Nausea
Sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion,InducedStudies 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
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sharon Orbach-Zinger, Study director, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361686
- Sponsor's protocol ID
- 3820
- Status last verified
- Jul 2006
- First submitted
- 6 Aug 2006
- Last updated
- 24 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Study Comparing Patient Controlled Analgesia With Tramadol vs. Remifentanyl for Women Undergoing 2nd Trimester Abortions
- ClinicalTrials.gov ID
- NCT00361686
- Acronym / sponsor ID
- 3820
- Conditions
- Abortion,Induced
- Keywords
- tramadol, remifentanyl, patient controlled analgesia, abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 8 Aug 2006 (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.
Patients undergoing second trimester abortions will recieve either patient controlled analgesia with either remifentanyl or tramadol for pain alleviation.
We beleive both to be equally effective for pain alleviation.
Detailed description
Women undergoing second trimester abortions will recieve patient controlled analgesia eith either tramadol or remifentanyl.
Patients will not know what they are recieving.
Patients in the tramadol goup will get a loading dose of tramadol and metocloparamide while the women in the remifentanyl group will be given a loading placebo.
Women will then be attached to one of the two patinet controlled analgesia protocols.
Throughout their laboring process they will be monitored for blood pressure, pulse, breathing rate, sedation score and nausea.
Additional medicatyion will be given for nausea.
If woman are still in pain the patient controlled analgesia settings will be set to deliver a higher dose. If the woman remains in pain, she will be given an additional per os medication.If this still does not alleviate pain, the option of epidural analgesia will be offered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Woman undergoing 2nd trimester abortion -
Key exclusion criteria (4 listed)
- Seizure disorder
- Inability to recieve patient controlled analgesia
- Allergy to tramadol or remifentanyl
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 |
|---|---|---|
| tramadol | Drug | – |
| remifentanyl | Drug | – |
| patient contolled analgesia | Device | – |
Primary outcome
Satisfaction
VAS scores
Nausea
Sedation
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 24 Nov 2015.
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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.
Sharon Orbach-Zinger study director
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tramadol, remifentanyl and patient contolled analgesia in people with Abortion,Induced, run by Rabin 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 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: finished, as of the sponsor's last update on 24 Nov 2015. 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?
Satisfaction. The study lists 4 primary outcomes in all. 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 24 Nov 2015.