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Flurbiprofen Axetil for Uterine Contraction Pain


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  • abortion
  • alcohol
  • allergy
  • bleeding
  • chronic diseases
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    • Purpose

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      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.


      status: completed
      conditions: Postoperative Pain
      interventions: Saline ; Flurbiprofen Axetil
      phase: Phase 4
      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

    • 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


      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

      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

      facility: Nanjing, Jiangsu, China, 210004

    • Sponsors and collaborators

      Nanjing Medical University

      investigators: XiaoFeng Shen, MD, Study Director, Nanjing Medical University

    • More information

      first received: July 28, 2008
      last updated: August 5, 2008
      ClinicalTrials.gov Identifier: NCT00725218
      health authority: China: Ethics Committee

    Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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