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

November 23, 2015 updated by: Rabin Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tiqvah, Israel
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Woman undergoing 2nd trimester abortion -

Exclusion Criteria:

  • Seizure disorder

    - * Psychiatric disorder

  • Inability to recieve patient controlled analgesia
  • Allergy to tramadol or remifentanyl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Satisfaction
Nausea
VAS scores
Sedation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Study Director: Sharon Orbach-Zinger, Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

August 6, 2006

First Submitted That Met QC Criteria

August 6, 2006

First Posted (Estimate)

August 8, 2006

Study Record Updates

Last Update Posted (Estimate)

November 24, 2015

Last Update Submitted That Met QC Criteria

November 23, 2015

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3820

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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