Comparison of Tramadol vs Remifentanyl Patient Controlled Analgesia for Second Trimester Abortions
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.
Device: patient contolled analgesia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Randomized Double Blind Study Comparing Patient Controlled Analgesia With Tramadol vs. Remifentanyl for Women Undergoing 2nd Trimester Abortions|
- VAS scores
|Study Start Date:||January 2006|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00361686
|Rabin Medical Center|
|Petach Tiqvah, Israel|
|Study Director:||Sharon Orbach-Zinger||Rabin Medical Center|