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

Abortion,Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361686
• Other study ID #: 3820
• Status: Completed
• Phase: N/A
• First received: August 6, 2006
• Last updated: November 23, 2015
• Start date: January 2006
• Est. completion date: January 2007

Study information

• Verified date: July 2006
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Woman undergoing 2nd trimester abortion -

Exclusion Criteria:

• Seizure disorder

• * Psychiatric disorder

• Inability to recieve patient controlled analgesia

• Allergy to tramadol or remifentanyl

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion,Induced

Intervention

Drug:
• tramadol

• remifentanyl

Device:
• patient contolled analgesia

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tiqvah

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction
Primary	VAS scores
Primary	Nausea
Primary	Sedation