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Flurbiprofen Axetil for Uterine Contraction Pain (FAUCOP)

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: NCT00725218
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : August 6, 2008
Sponsor:
Information provided by:
Nanjing Medical University

Study Description
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Brief Summary:
Uterine contraction pain is a common problem after abortion. Optimal analgesic for such suffering is still needed to be guaranteed. Flurbiprofen Axetil is a target-distributable non-steroidal anti-inflammatory drug (NSAID) functioning via block the synthesis of prostaglandin E (PGE). The investigators hypothesized that Flurbiprofen Axetil could suppress the uterine contraction pain after abortion effectively.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Saline Drug: Flurbiprofen Axetil Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of Flurbiprofen Axetil for Uterine Contraction Pain After Abortion
Study Start Date : May 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
Saline 5 ml injection 10 min prior to propofol administration.
 Drug: Saline
Saline 5 ml injection 10 min prior to propofol administration.
Other Name: Ringer's solution
Experimental: 2
Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.
 Drug: Flurbiprofen Axetil
Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.
Other Name: KaiFen


Outcome Measures
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Primary Outcome Measures :
  1. VAS pain scorings [ Time Frame: At the end of the operation, 0,5,15,30,60min after operation ]

Secondary Outcome Measures :
  1. Anesthetic consumptions [ Time Frame: At the end of the operation ]
  2. Overall VAS satisfaction scorings with analgesia [ Time Frame: At the end of the study ]
  3. Side effects [ Time Frame: During the whole period of the study ]
  4. Volume of bleeding [ Time Frame: At the end of the study ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA status I-II
  • Performing abortion operation (medical- or drug-induced
  • Requiring painless abortion

Exclusion Criteria:

  • < 19yrs, and >= 45yrs
  • History of central active drugs administration
  • Drug abuse
  • Hypertension
  • Diabetes
  • Any other chronic diseases
  • Allergy to the study drugs
  • Habit of over-volume alcohol drinking
  • Records of history of centrally active drug use and psychiatry
  • Any organic disorders
Contacts and Locations
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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): NCT00725218


Locations
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China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Study Director: XiaoFeng Shen, MD Nanjing Medical University
More Information
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Responsible Party: XiaoFeng Shen, Nanjing Maternal and Child Health Hospital
ClinicalTrials.gov Identifier: NCT00725218    
Other Study ID Numbers: NMU-MZ203
M089732
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: August 6, 2008
Last Verified: May 2008
Keywords provided by Nanjing Medical University:
NSAIDs
Postoperative pain
Analgesia
Abortion
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Flurbiprofen
Flurbiprofen axetil
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action