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Effect of Paracetamol, Dexketoprofen Trometamol, Lidocaine Spray, Pethidine and Diclofenac Sodium Application for Pain Relief During Fractional Curettage

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ClinicalTrials.gov Identifier: NCT01993589
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Gökhan Açmaz, Kayseri Education and Research Hospital

Tracking Information
First Submitted Date  ICMJE November 9, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date November 25, 2013
Study Start Date  ICMJE November 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
Pain [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Paracetamol, Dexketoprofen Trometamol, Lidocaine Spray, Pethidine and Diclofenac Sodium Application for Pain Relief During Fractional Curettage
Official Title  ICMJE Not Provided
Brief Summary Patients frequently experience pain from moderate to severe during gynecologic procedures. This study is a prospective, randomized, placebo-controlled trial and aimed to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage procedure.
Detailed Description A total of 144 mutiparous subjects randomly allocated one of six groups. The first group (control group) consisted of 22 participants and they did not receive any treatment. The second group consisted of 26 participants receiving oral 25 mg dexketoprofen trometamol. The third group consisted of 23 participants receiving 2 puff lidocaine sprays on cervical mucosa. The forth group consisted of 25 participants receiving 100 mg pethidine. The fifth group consisted of 23 participants receiving 1000 mg intravenous paracetamol and the sixth group consisted of 25 participants receiving diclofenac sodium.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain and Curettage
Intervention  ICMJE
  • Drug: comparison of pain relievers during curattage
  • Drug: comparison of pain relievers
Study Arms  ICMJE
  • No Intervention: Control group
    Control group
  • Active Comparator: Pain reliever
    1000 mg paracetamol (Parol 1 g Atabay ilaç Turkey)
    Intervention: Drug: comparison of pain relievers during curattage
  • Active Comparator: Dexketoprofen trometamol
    25 mg oral Dexofen Atabay ilaç Turkey
    Intervention: Drug: comparison of pain relievers
  • Active Comparator: Lidocaine spray
    2 puff on cervical mucosa (Xylocain Pump 100 Mg 50 Ml Sprey Astra Zeneca)
    Intervention: Drug: comparison of pain relievers during curattage
  • Active Comparator: pethidine
    Aldolan 100 mg Liba Laboratuarı İstanbul Turkey
    Intervention: Drug: comparison of pain relievers during curattage
  • Active Comparator: diclofenac sodium
    Dicloron amp 75 mg Deva İlaç Levent İstanbul/Turkey
    Intervention: Drug: comparison of pain relievers during curattage
Publications * Acmaz G, Bayraktar E, Aksoy H, Başer M, Yilmaz MO, Müderris İİ. Effect of paracetamol, dexketoprofen trometamol, lidocaine spray, pethidine & diclofenac sodium application for pain relief during fractional curettage: A randomized controlled trial. Indian J Med Res. 2015 Oct;142(4):399-404. doi: 10.4103/0971-5916.169197.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2013)
144
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • multiparous participants
  • abnormal uterine bleeding
  • postmenopausal bleeding
  • myoma uteri causing menometrorrhagia
  • cervical polyp
  • tamoxifen treatment for breast cancer
  • adnexial mass

Exclusion Criteria:

  • abortions
  • pregnancy
  • primiparity
  • diabetes mellitus
  • tendency to bleed such as thrombocytopenia
  • factor deficiency
  • functional disorders of platelets
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993589
Other Study ID Numbers  ICMJE {kayseriERH}
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gökhan Açmaz, Kayseri Education and Research Hospital
Study Sponsor  ICMJE Kayseri Education and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kayseri Education and Research Hospital
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP