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Comparison of Tramadol vs Remifentanyl Patient Controlled Analgesia for Second Trimester Abortions

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ClinicalTrials.gov Identifier: NCT00361686
Recruitment Status : Completed
First Posted : August 8, 2006
Last Update Posted : November 24, 2015
Sponsor:
Information provided by:
Rabin Medical Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Abortion,Induced Drug: tramadol Drug: remifentanyl Device: patient contolled analgesia Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized Double Blind Study Comparing Patient Controlled Analgesia With Tramadol vs. Remifentanyl for Women Undergoing 2nd Trimester Abortions
Study Start Date : January 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Primary Outcome Measures :
  1. Satisfaction
  2. VAS scores
  3. Nausea
  4. Sedation

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Woman undergoing 2nd trimester abortion -

Exclusion Criteria:

  • Seizure disorder

    - * Psychiatric disorder

  • Inability to recieve patient controlled analgesia
  • Allergy to tramadol or remifentanyl
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361686


Locations
Israel
Rabin Medical Center
Petach Tiqvah, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
Study Director: Sharon Orbach-Zinger Rabin Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00361686     History of Changes
Other Study ID Numbers: 3820
First Posted: August 8, 2006    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: July 2006

Keywords provided by Rabin Medical Center:
tramadol
remifentanyl
patient controlled analgesia
abortion

Additional relevant MeSH terms:
Tramadol
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics