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

NCT ID: NCT00361686

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-01-31

Brief Summary

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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

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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

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Abortion,Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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tramadol

Intervention Type DRUG

remifentanyl

Intervention Type DRUG

patient contolled analgesia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Woman undergoing 2nd trimester abortion -

Exclusion Criteria

* Seizure disorder

\- \* Psychiatric disorder
* Inability to recieve patient controlled analgesia
* Allergy to tramadol or remifentanyl
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Sharon Orbach-Zinger

Role: STUDY_DIRECTOR

Rabin Medical Center

Locations

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Rabin Medical Center

Petach Tiqvah, , Israel

Site Status

Countries

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Israel

Other Identifiers

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3820

Identifier Type: -

Identifier Source: org_study_id