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
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring NSAIDs, Postoperative pain, Analgesia, Abortion
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
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
NCT ID
NCT00725218
First Posted
July 28, 2008
Last Updated
August 5, 2008
Sponsor
Nanjing Medical University
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
Learn more about this trial
Flurbiprofen Axetil for Uterine Contraction Pain
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