Postoperative Pain After Medical Abortion Under Local Ane... | NCT00188071

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

NCT00188071

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Nov 1, 2017Actual

Enrollment

240

Phase

Not Applicable

Conditions

Abortion, Induced

Interventions

paracetamol
ketoprofen
ketoprofen + paracetamol

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Not provided

Completion Date

Aug 2003

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2017

Last Update Posted Date

Nov 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240

Measure	Description	Time Frame
postoperative pain rating

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

under 18 year old

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean Claude Granry, MD	University Hospital, Angers	Study Chair
Emmanuel Mucci, MD	University Hospital, Angers	Principal Investigator
Christine Monrigal, MD	Dept of Anesthesia, CHU, Angers - France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Anesthesia - CHU		Angers		49933	France

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen
D007660	Ketoprofen

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
paracetamol	Drug
ketoprofen	Drug
ketoprofen + paracetamol	Drug

Measure	Description	Time Frame
morphine consumption
patient satisfaction