Flurbiprofen Axetil for Uterine Contraction Pain

Postoperative Pain Clinical Trial

— FAUCOP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725218
• Other study ID #: NMU-MZ203
• Secondary ID: M089732
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2008
• Last updated: August 5, 2008
• Start date: May 2008
• Est. completion date: August 2008

Study information

• Verified date: May 2008
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Saline
Saline 5 ml injection 10 min prior to propofol administration.
• Flurbiprofen Axetil
Flurbiprofen Axetil 50 mg in 5 ml injection 10min prior to propofol administration.

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain scorings		At the end of the operation, 0,5,15,30,60min after operation	Yes
Secondary	Anesthetic consumptions		At the end of the operation	Yes
Secondary	Overall VAS satisfaction scorings with analgesia		At the end of the study	No
Secondary	Side effects		During the whole period of the study	Yes
Secondary	Volume of bleeding		At the end of the study	Yes