Flurbiprofen Axetil for Uterine Contraction Pain - Full Text View

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 4


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

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
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 Name: 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 Name: KaiFen

Eligibility


Ages Eligible for Study:	19 Years to 45 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Keywords provided by Nanjing Medical University:


NSAIDs Postoperative pain Analgesia Abortion

Additional relevant MeSH terms:


Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms Propofol Flurbiprofen Flurbiprofen axetil Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs	Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016

Flurbiprofen Axetil for Uterine Contraction Pain (FAUCOP)