IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02373514
• Other study ID #: 57051259-020/70177
• Status: Recruiting
• Phase: Phase 4
• First received: February 23, 2015
• Last updated: February 26, 2015
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: February 2015
• Source: Akdeniz University
• Contact: Cenker Eken, Medical Doctor
• Phone: 0090 532 1593948
• Email: cenkereken[@]akdeniz.edu.tr
• Is FDA regulated: No
• Health authority: Pamukkale University:Turkey
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• Paracetamol
1 gr paracetamol in 100 ml saline with rapid infusion
• Dexketoprofen
50 mg dexketoprofen in 100 ml saline with rapid infusion

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	Change in visual analogue scale at 15th minutes from baseline	15 minutes	No
Primary	Visual Analogue Scale	Change in visual analogue scale at 30th minutes from baseline	30 minutes	No
Secondary	Rescue drug need		30 minutes	No
Secondary	Adverse effects		30 minutes	Yes