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

Tracking Information

First Received Date ^ICMJE

August 6, 2006

Last Updated Date

August 6, 2006

Start Date ^ICMJE

January 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Satisfaction
VAS scores
Nausea
Sedation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomized Double Blind Study Comparing Patient Controlled Analgesia With Tramadol Vs. Remifentanyl for Women Undergoing 2nd Trimester Abortions

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Abortion,Induced

Intervention ^ICMJE

Drug: tramadol
Drug: remifentanyl
Device: patient contolled analgesia

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Woman undergoing 2nd trimester abortion -

Exclusion Criteria:

Seizure disorder

- * Psychiatric disorder
Inability to recieve patient controlled analgesia
Allergy to tramadol or remifentanyl

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00361686

Responsible Party

Study ID Numbers ^ICMJE

3820

Study Sponsor ^ICMJE

Rabin Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Sharon Orbach-Zinger

Rabin Medical Center

Information Provided By

Rabin Medical Center

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP