NCT00361686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

November 24, 2015

Status Verified

July 1, 2006

Enrollment Period

1 year

First QC Date

August 6, 2006

Last Update Submit

November 23, 2015

Conditions

Abortion,Induced

Keywords

tramadolremifentanylpatient controlled analgesiaabortion

Outcome Measures

Primary Outcomes (4)

  • Satisfaction

  • VAS scores

  • Nausea

  • Sedation

Interventions

tramadolDRUG
remifentanylDRUG
patient contolled analgesiaDEVICE

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Woman undergoing 2nd trimester abortion -

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petach Tiqvah, Israel

Location

MeSH Terms

Interventions

TramadolRemifentanil

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sharon Orbach-Zinger

    Rabin Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2006

First Posted

August 8, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

November 24, 2015

Record last verified: 2006-07

Locations

IL(1)