Flurbiprofen Axetil for Uterine Contraction Pain - Full Text View

Sponsor:	Nanjing Medical University
Information provided by:	Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT00725218

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase IV Study of Flurbiprofen Axetil for Uterine Contraction Pain After Abortion

Resource links provided by NLM:

Drug Information available for: Flurbiprofen sodium Flurbiprofen

U.S. FDA Resources

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
1: Placebo Comparator Saline 5 ml injection 10 min prior to propofol administration.	Drug: Saline Saline 5 ml injection 10 min prior to propofol administration.
2: Experimental 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.

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

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:	Nanjing Maternal and Child Health Hospital ( XiaoFeng Shen )
Study ID Numbers:	NMU-MZ203, M089732
Study First Received:	July 28, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00725218 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

NSAIDs
Postoperative pain
Analgesia
Abortion

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications

Flurbiprofen
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on February 08, 2010