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IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea

Primary Purpose

Dysmenorrhea

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Paracetamol
Dexketoprofen
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysmenorrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pamukkale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Paracetamol

Dexketoprofen

Arm Description

Intravenous 1 gm paracetamol in 100 ml saline with rapid infusion

Intravenous 50 mg dexketoprofen in 100 ml saline with rapid infusion

Outcomes

Primary Outcome Measures

Visual Analogue Scale
Change in visual analogue scale at 15th minutes from baseline
Visual Analogue Scale
Change in visual analogue scale at 30th minutes from baseline

Secondary Outcome Measures

Rescue drug need
Adverse effects

Full Information

First Posted
February 23, 2015
Last Updated
February 26, 2015
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT02373514
Brief Title
IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea
Official Title
Intravenous Paracetamol Versus Intravenous Dexketoprofen in Patients Presented With Dysmenorrhea in Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Description
Intravenous 1 gm paracetamol in 100 ml saline with rapid infusion
Arm Title
Dexketoprofen
Arm Type
Active Comparator
Arm Description
Intravenous 50 mg dexketoprofen in 100 ml saline with rapid infusion
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Perfalgan
Intervention Description
1 gr paracetamol in 100 ml saline with rapid infusion
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen
Other Intervention Name(s)
Arveles
Intervention Description
50 mg dexketoprofen in 100 ml saline with rapid infusion
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Change in visual analogue scale at 15th minutes from baseline
Time Frame
15 minutes
Title
Visual Analogue Scale
Description
Change in visual analogue scale at 30th minutes from baseline
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Rescue drug need
Time Frame
30 minutes
Title
Adverse effects
Time Frame
30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cenker Eken, Medical Doctor
Phone
0090 532 1593948
Email
cenkereken@akdeniz.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Serinken, MD
Phone
0090 505 2991497
Email
aserinken@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Serinken, MD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Serinken, MD
Phone
0090 505 2991497
Email
aserinken@hotmail.com

12. IPD Sharing Statement

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IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea

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