Flurbiprofen Axetil for Uterine Contraction Pain (FAUCOP)

August 5, 2008 updated by: Nanjing Medical University

Phase IV Study of Flurbiprofen Axetil for Uterine Contraction Pain After Abortion

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • KaiFen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS pain scorings
Time Frame: At the end of the operation, 0,5,15,30,60min after operation
At the end of the operation, 0,5,15,30,60min after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Anesthetic consumptions
Time Frame: At the end of the operation
At the end of the operation
Overall VAS satisfaction scorings with analgesia
Time Frame: At the end of the study
At the end of the study
Side effects
Time Frame: During the whole period of the study
During the whole period of the study
Volume of bleeding
Time Frame: At the end of the study
At the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 28, 2008

First Posted (ESTIMATE)

July 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2008

Last Update Submitted That Met QC Criteria

August 5, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-MZ203
  • M089732

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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