Comparison of Tramadol Vs Remifentanyl Patient Controlled Analgesia for Second Trimester Abortions - Full Text View

Sponsor:	Rabin Medical Center
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00361686

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:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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 Remifentanil

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
Estimated Study Completion Date:	July 2006

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361686

Locations

Israel
Rabin Medical Center	Recruiting
Petach Tiqvah, Israel
Contact: Sharon Orbach-Zinger 837 6811 sharonorbach@yahoo.com
Principal Investigator: Ella Nichinson, MD
Sub-Investigator: Andrei Chinchuck, MD

Sponsors and Collaborators

Rabin Medical Center

Investigators

Study Director:

Sharon Orbach-Zinger

Rabin Medical Center

More Information

No publications provided

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

Keywords provided by Rabin Medical Center:

tramadol
remifentanyl
patient controlled analgesia
abortion

Additional relevant MeSH terms:

Anesthetics, Intravenous
Remifentanil
Tramadol
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions

Anesthetics, General
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010