Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen

October 30, 2017 updated by: University Hospital, Angers

Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen

  • To compare postoperative analgesia by paracetamol 1gr or ketoprofen 100 mg or the combination of these two analgesics
  • each treatment beeing allocated by randomization

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • 240 pregnant women who undewent a medical abortion by aspiration, under local anesthesia, (day case surgery) were enrolled after informed consent and signed approval

  • according to randomization, they received one hour before medical abortion procedure performed under local anesthesia of the cervix, one of these three diffrente analgesics :

    • paracetamol 1 gr
    • ketoprofen 100 mg
    • the association of both Postprocedure pain was recorded, by nurse, using a visual analog scale (VAS), 7 times before and after the procedure, until the discharge of the patient.
  • if VAS was above 40 on two consecutive measurements a morphine injection was given.
  • the number and total amount of morphine was recorded.
  • satisfaction was recorded within the 3 postoperative day by a telephone inquiry.

Study Type

Interventional

Enrollment

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Dept of Anesthesia - CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women
  • medical abortion performed in day case surgery under local anesthesia
  • informed written consent

Exclusion Criteria:

  • under 18 year old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
postoperative pain rating

Secondary Outcome Measures

Outcome Measure
morphine consumption
patient satisfaction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Study Chair: Jean Claude Granry, MD, University hospital, Angers, FRANCE
  • Principal Investigator: Emmanuel Mucci, MD, University hospital, Angers, FRANCE
  • Study Director: Christine Monrigal, MD, Dept of Anesthesia, CHU, Angers - France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion

December 7, 2022

Study Completion

August 1, 2003

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP 02-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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