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

November 20, 2013 updated by: Gökhan Açmaz, Kayseri Education and Research Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey, 38210
        • Kayseri Education and Research Hospital of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kayseri Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 9, 2013

First Submitted That Met QC Criteria

November 20, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • {kayseriERH}

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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