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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00188071
First received: September 12, 2005
Last updated: December 28, 2005
Last verified: September 2005
  Purpose
  • 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 Intervention
Abortion, Induced
Drug: paracetamol
Drug: ketoprofen
Drug: ketoprofen + paracetamol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • postoperative pain rating

Secondary Outcome Measures:
  • morphine consumption
  • patient satisfaction

Estimated Enrollment: 240
Study Start Date: September 2002
Estimated Study Completion Date: August 2003
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00188071     History of Changes
Other Study ID Numbers: CP 02-02
Study First Received: September 12, 2005
Last Updated: December 28, 2005
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Angers:
medical abortion
analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Ketoprofen
Analgesics
Anesthetics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014