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

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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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources




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, Senior)
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
France
Dept of Anesthesia - CHU
Angers, France, 49933
Sponsors and Collaborators
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

ClinicalTrials.gov Identifier: NCT00188071     History of Changes
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

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:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics
Acetaminophen
Ketoprofen
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action