IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea

February 26, 2015 updated by: Cenker Eken, Akdeniz University

Intravenous Paracetamol Versus Intravenous Dexketoprofen in Patients Presented With Dysmenorrhea in Emergency Department

Patients presented with dysmenorrhea composed the study population. One gram paracetamol and 50 mg dexketoprofen in 100 ml saline with a rapid infusion were compared in ceasing dysmenorrhea in emergency department.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients over 18 years old who presented with dysmenorrhea composed the study population. Patients received pain killer within the last six hours, physical findings consistent with peritoneal irritation, allergy to the study drugs, renal or liver failure, drug addiction, pregnancy or woman with lactation and denied to give inform consent were the exclusion criteria. The pain of the study patients are measured with visual analogue scale at baseline, 15th and 30th minutes. At the end of the 30 minutes, rescue drug need is also recorded.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

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
      • Denizli, Turkey
        • Recruiting
        • Pamukkale University
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with dysmenorrhea
  • Patients over 18 years old

Exclusion Criteria:

  • denied to give inform consent
  • Renal or liver failure
  • Allergy to the study drugs
  • Receiving pain killer within the last 6 hours.
  • Physical examination findings consistent with peritoneal irritation
  • Pregnancy or patients with lactation
  • Drug addiction

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
Active Comparator: Paracetamol
Intravenous 1 gm paracetamol in 100 ml saline with rapid infusion
Drug: Paracetamol
1 gr paracetamol in 100 ml saline with rapid infusion
Other Names:
  • Perfalgan
Active Comparator: Dexketoprofen
Intravenous 50 mg dexketoprofen in 100 ml saline with rapid infusion
Drug: Dexketoprofen
50 mg dexketoprofen in 100 ml saline with rapid infusion
Other Names:
  • Arveles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 15 minutes
Change in visual analogue scale at 15th minutes from baseline
15 minutes
Visual Analogue Scale
Time Frame: 30 minutes
Change in visual analogue scale at 30th minutes from baseline
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse effects
Time Frame: 30 minutes
30 minutes
Rescue drug need
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

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

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Mustafa Serinken, MD, Pamukkale University

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

January 1, 2015

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

February 23, 2015

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Estimate)

February 27, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57051259-020/70177

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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