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
  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:


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 July 24, 2016