IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea
Intravenous Paracetamol Versus Intravenous Dexketoprofen in Patients Presented With Dysmenorrhea in Emergency Department
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 23, 2015
CompletedFirst Posted
Study publicly available on registry
February 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFebruary 27, 2015
February 1, 2015
2 months
February 23, 2015
February 26, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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 (2)
Rescue drug need
30 minutes
Adverse effects
30 minutes
Study Arms (2)
Paracetamol
ACTIVE COMPARATORIntravenous 1 gm paracetamol in 100 ml saline with rapid infusion
Dexketoprofen
ACTIVE COMPARATORIntravenous 50 mg dexketoprofen in 100 ml saline with rapid infusion
Interventions
1 gr paracetamol in 100 ml saline with rapid infusion
50 mg dexketoprofen in 100 ml saline with rapid infusion
Eligibility Criteria
You may qualify if:
- Patients with dysmenorrhea
- Patients over 18 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University
Denizli, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mustafa Serinken, MD
Pamukkale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 23, 2015
First Posted
February 27, 2015
Study Start
January 1, 2015
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
February 27, 2015
Record last verified: 2015-02