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Flurbiprofen Axetil for Uterine Contraction Pain (FAUCOP)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Saline
Flurbiprofen Axetil
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring NSAIDs, Postoperative pain, Analgesia, Abortion

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nanjing Maternal and Child Health Care Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Saline 5 ml injection 10 min prior to propofol administration.

Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.

Outcomes

Primary Outcome Measures

VAS pain scorings

Secondary Outcome Measures

Anesthetic consumptions
Overall VAS satisfaction scorings with analgesia
Side effects
Volume of bleeding

Full Information

First Posted
July 28, 2008
Last Updated
August 5, 2008
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00725218
Brief Title
Flurbiprofen Axetil for Uterine Contraction Pain
Acronym
FAUCOP
Official Title
Phase IV Study of Flurbiprofen Axetil for Uterine Contraction Pain After Abortion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
NSAIDs, Postoperative pain, Analgesia, Abortion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Saline 5 ml injection 10 min prior to propofol administration.
Arm Title
2
Arm Type
Experimental
Arm Description
Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Ringer's solution
Intervention Description
Saline 5 ml injection 10 min prior to propofol administration.
Intervention Type
Drug
Intervention Name(s)
Flurbiprofen Axetil
Other Intervention Name(s)
KaiFen
Intervention Description
Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.
Primary Outcome Measure Information:
Title
VAS pain scorings
Time Frame
At the end of the operation, 0,5,15,30,60min after operation
Secondary Outcome Measure Information:
Title
Anesthetic consumptions
Time Frame
At the end of the operation
Title
Overall VAS satisfaction scorings with analgesia
Time Frame
At the end of the study
Title
Side effects
Time Frame
During the whole period of the study
Title
Volume of bleeding
Time Frame
At the end of the study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XiaoFeng Shen, MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternal and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China

12. IPD Sharing Statement

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Flurbiprofen Axetil for Uterine Contraction Pain

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