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

Condition(s) targeted: Abortion,Induced

Intervention: tramadol (Drug); remifentanyl (Drug); patient contolled analgesia (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Sharon Orbach-Zinger, Study Director, Affiliation: Rabin Medical Center

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.

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

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

Primary outcome:

Satisfaction

VAS scores

Nausea

Sedation

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.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

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

Starting date: January 2006
Ending date: July 2006
Last updated: August 6, 2006