IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea | NCT02373514

Studies
IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea

NCT02373514

Sponsor

Akdeniz University

Status

Unknown status

Last Update Posted

Feb 27, 2015Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Dysmenorrhea

Interventions

Paracetamol
Dexketoprofen

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Mar 2015Estimated

Completion Date

Mar 2015Estimated

First Submitted Date

Feb 23, 2015

First Submission Date that Met QC Criteria

Feb 26, 2015

First Posted Date

Feb 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2015

Last Update Posted Date

Feb 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paracetamol	Active Comparator	Intravenous 1 gm paracetamol in 100 ml saline with rapid infusion	Drug: Paracetamol
Dexketoprofen	Active Comparator	Intravenous 50 mg dexketoprofen in 100 ml saline with rapid infusion	Drug: Dexketoprofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paracetamol	Drug	1 gr paracetamol in 100 ml saline with rapid infusion	Paracetamol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Rescue drug need		30 minutes
Adverse effects		30 minutes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cenker Eken, Medical Doctor	Contact	0090 532 1593948		cenkereken@akdeniz.edu.tr
Mustafa Serinken, MD	Contact	0090 505 2991497		aserinken@hotmail.com

Overall Officials

Name	Affiliation	Role
Mustafa Serinken, MD	Pamukkale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pamukkale University	Recruiting	Denizli			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D004412	Dysmenorrhea

Ancestor Terms

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D017699	Pelvic Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen
C118296	dexketoprofen trometamol

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided