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IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea

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: NCT02373514
Recruitment Status : Unknown
Verified February 2015 by Cenker Eken, Akdeniz University.
Recruitment status was:  Recruiting
First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Information provided by (Responsible Party):
Cenker Eken, Akdeniz University

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.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: Paracetamol Drug: Dexketoprofen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Paracetamol Versus Intravenous Dexketoprofen in Patients Presented With Dysmenorrhea in Emergency Department
Study Start Date : January 2015
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

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 Name: 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 Name: Arveles




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 15 minutes ]
    Change in visual analogue scale at 15th minutes from baseline

  2. Visual Analogue Scale [ Time Frame: 30 minutes ]
    Change in visual analogue scale at 30th minutes from baseline


Secondary Outcome Measures :
  1. Rescue drug need [ Time Frame: 30 minutes ]
  2. Adverse effects [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT02373514


Contacts
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Contact: Cenker Eken, Medical Doctor 0090 532 1593948 cenkereken@akdeniz.edu.tr
Contact: Mustafa Serinken, MD 0090 505 2991497 aserinken@hotmail.com

Locations
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Turkey
Pamukkale University Recruiting
Denizli, Turkey
Contact: Mustafa Serinken, MD    0090 505 2991497    aserinken@hotmail.com   
Sponsors and Collaborators
Akdeniz University
Investigators
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Principal Investigator: Mustafa Serinken, MD Pamukkale University

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Responsible Party: Cenker Eken, Associate Professor, Akdeniz University
ClinicalTrials.gov Identifier: NCT02373514    
Other Study ID Numbers: 57051259-020/70177
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: February 27, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Dexketoprofen trometamol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents