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Flurbiprofen Axetil for Uterine Contraction Pain (FAUCOP)
This study has been completed.
Sponsor:
Nanjing Medical University
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00725218
First received: July 28, 2008
Last updated: August 5, 2008
Last verified: May 2008
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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:
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 ]
Secondary Outcome Measures:
- Anesthetic consumptions [ Time Frame: At the end of the operation ]
- Overall VAS satisfaction scorings with analgesia [ Time Frame: At the end of the study ]
- Side effects [ Time Frame: During the whole period of the study ]
- Volume of bleeding [ Time Frame: At the end of the study ]
| 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) |
| Sexes 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00725218
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 |
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 axetil Flurbiprofen Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs |
Anesthetics, Intravenous Anesthetics, General Anesthetics Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 23, 2017