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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Pain and Curettage Drug: comparison of pain relievers during curattage Drug: comparison of pain relievers Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Arm Intervention/treatment
No Intervention: Control group
Control group
Active Comparator: Pain reliever
1000 mg paracetamol (Parol 1 g Atabay ilaç Turkey)
Drug: comparison of pain relievers during curattage
Active Comparator: Dexketoprofen trometamol
25 mg oral Dexofen Atabay ilaç Turkey
Drug: comparison of pain relievers
Active Comparator: Lidocaine spray
2 puff on cervical mucosa (Xylocain Pump 100 Mg 50 Ml Sprey Astra Zeneca)
Drug: comparison of pain relievers during curattage
Active Comparator: pethidine
Aldolan 100 mg Liba Laboratuarı İstanbul Turkey
Drug: comparison of pain relievers during curattage
Active Comparator: diclofenac sodium
Dicloron amp 75 mg Deva İlaç Levent İstanbul/Turkey
Drug: comparison of pain relievers during curattage



Primary Outcome Measures :
  1. Pain [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993589


Locations
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Turkey
Kayseri Education and Research Hospital of Medicine
Kayseri, Turkey, 38210
Sponsors and Collaborators
Kayseri Education and Research Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gökhan Açmaz, MD, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01993589    
Other Study ID Numbers: {kayseriERH}
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Gökhan Açmaz, Kayseri Education and Research Hospital:
Curettage; analgesia; paracetamol; lidocaine; Dexketoprofen trometamol; pethidine; diclofenac.
Additional relevant MeSH terms:
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Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics