Back to resultsPostoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen
Primary Purpose
Abortion, Induced
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
paracetamol
ketoprofen
ketoprofen + paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Abortion, Induced focused on measuring medical abortion, analgesia
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
Sites / Locations
- Dept of Anesthesia - CHU
Outcomes
Primary Outcome Measures
postoperative pain rating
Secondary Outcome Measures
morphine consumption
patient satisfaction
Full Information
NCT ID
NCT00188071
First Posted
September 12, 2005
Last Updated
October 30, 2017
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT00188071
Brief Title
Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen
Official Title
Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Induced
Keywords
medical abortion, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
240 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
paracetamol
Intervention Type
Drug
Intervention Name(s)
ketoprofen
Intervention Type
Drug
Intervention Name(s)
ketoprofen + paracetamol
Primary Outcome Measure Information:
Title
postoperative pain rating
Secondary Outcome Measure Information:
Title
morphine consumption
Title
patient satisfaction
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Claude Granry, MD
Organizational Affiliation
University hospital, Angers, FRANCE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emmanuel Mucci, MD
Organizational Affiliation
University hospital, Angers, FRANCE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Monrigal, MD
Organizational Affiliation
Dept of Anesthesia, CHU, Angers - France
Official's Role
Study Director
Facility Information:
Facility Name
Dept of Anesthesia - CHU
City
Angers
ZIP/Postal Code
49933
Country
France
12. IPD Sharing Statement
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Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen
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