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

This study has been completed.

Sponsor:

Information provided by:

Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT00361686

First received: August 6, 2006

Last updated: November 23, 2015

Last verified: July 2006

History of Changes

Purpose

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	Intervention
Abortion,Induced	Drug: tramadol Drug: remifentanyl Device: patient contolled analgesia


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Randomized Double Blind Study Comparing Patient Controlled Analgesia With Tramadol vs. Remifentanyl for Women Undergoing 2nd Trimester Abortions

Resource links provided by NLM:

Drug Information available for: Tramadol Remifentanil hydrochloride

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:

Satisfaction
VAS scores
Nausea
Sedation


Estimated Enrollment:	40
Study Start Date:	January 2006
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

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.

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


ClinicalTrials.gov Identifier:	NCT00361686 History of Changes
Other Study ID Numbers:	3820
Study First Received:	August 6, 2006
Last Updated:	November 23, 2015
Health Authority:	Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 28, 2016

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