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
  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:


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
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: 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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014