IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea

NCT ID: NCT02373514

Last Updated: 2015-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paracetamol

Intravenous 1 gm paracetamol in 100 ml saline with rapid infusion

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

1 gr paracetamol in 100 ml saline with rapid infusion

Dexketoprofen

Intravenous 50 mg dexketoprofen in 100 ml saline with rapid infusion

Group Type ACTIVE_COMPARATOR

Dexketoprofen

Intervention Type DRUG

50 mg dexketoprofen in 100 ml saline with rapid infusion

Interventions

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Paracetamol

1 gr paracetamol in 100 ml saline with rapid infusion

Intervention Type DRUG

Dexketoprofen

50 mg dexketoprofen in 100 ml saline with rapid infusion

Intervention Type DRUG

Other Intervention Names

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Perfalgan Arveles

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Cenker Eken

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mustafa Serinken, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Cenker Eken, Medical Doctor

Role: CONTACT

Phone: 0090 532 1593948

Email: [email protected]

Mustafa Serinken, MD

Role: CONTACT

Phone: 0090 505 2991497

Email: [email protected]

Facility Contacts

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Mustafa Serinken, MD

Role: primary

Other Identifiers

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57051259-020/70177

Identifier Type: -

Identifier Source: org_study_id