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Flurbiprofen Axetil for Uterine Contraction Pain (FAUCOP)

This study has been completed.
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00725218
First received: July 28, 2008
Last updated: August 5, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention Phase
Postoperative Pain
 Drug: Saline
Drug: Flurbiprofen Axetil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase IV Study of Flurbiprofen Axetil for Uterine Contraction Pain After Abortion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • VAS pain scorings [ Time Frame: At the end of the operation, 0,5,15,30,60min after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anesthetic consumptions [ Time Frame: At the end of the operation ] [ Designated as safety issue: Yes ]
  • Overall VAS satisfaction scorings with analgesia [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: During the whole period of the study ] [ Designated as safety issue: Yes ]
  • Volume of bleeding [ Time Frame: At the end of the study ] [ Designated as safety issue: Yes ]

Enrollment: 97
Study Start Date: May 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725218

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Maternal and Child Health Hospital
ClinicalTrials.gov Identifier: NCT00725218     History of Changes
Other Study ID Numbers: NMU-MZ203, M089732
Study First Received: July 28, 2008
Last Updated: August 5, 2008
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
NSAIDs
Postoperative pain
Analgesia
Abortion

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

ClinicalTrials.gov processed this record on May 21, 2013