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

NCT ID: NCT00188071

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-08-31

Brief Summary

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

Detailed Description

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* 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.

Conditions

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Abortion, Induced

Keywords

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medical abortion analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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paracetamol

Intervention Type DRUG

ketoprofen

Intervention Type DRUG

ketoprofen + paracetamol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* under 18 year old
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Jean Claude Granry, MD

Role: STUDY_CHAIR

University hospital, Angers, FRANCE

Emmanuel Mucci, MD

Role: PRINCIPAL_INVESTIGATOR

University hospital, Angers, FRANCE

Christine Monrigal, MD

Role: STUDY_DIRECTOR

Dept of Anesthesia, CHU, Angers - France

Locations

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Dept of Anesthesia - CHU

Angers, , France

Site Status

Countries

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France

Other Identifiers

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CP 02-02

Identifier Type: -

Identifier Source: org_study_id