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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00188071
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : November 1, 2017
Sponsor:
Information provided by:
University Hospital, Angers

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

Condition or disease Intervention/treatment Phase
Abortion, Induced Drug: paracetamol Drug: ketoprofen Drug: ketoprofen + paracetamol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen
Study Start Date : September 2002
Study Completion Date : August 2003



Primary Outcome Measures :
  1. postoperative pain rating

Secondary Outcome Measures :
  1. morphine consumption
  2. patient satisfaction


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • under 18 year old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188071


Locations
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France
Dept of Anesthesia - CHU
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Investigators
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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

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ClinicalTrials.gov Identifier: NCT00188071    
Other Study ID Numbers: CP 02-02
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: September 2005

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
medical abortion
analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ketoprofen
Analgesics
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action