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IV Paracetamol Versus IV Dexketoprofen in Dysmenorrhea

A

Akdeniz University

Status and phase

Unknown
Phase 4

Conditions

Dysmenorrhea

Treatments

Drug: Dexketoprofen
Drug: Paracetamol

Study type

Interventional

Funder types

Other

Identifiers

NCT02373514
57051259-020/70177

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups

Paracetamol
Active Comparator group
Description:
Intravenous 1 gm paracetamol in 100 ml saline with rapid infusion
Treatment:
Drug: Paracetamol
Dexketoprofen
Active Comparator group
Description:
Intravenous 50 mg dexketoprofen in 100 ml saline with rapid infusion
Treatment:
Drug: Dexketoprofen

Trial contacts and locations

1

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Central trial contact

Cenker Eken, Medical Doctor; Mustafa Serinken, MD

Data sourced from clinicaltrials.gov

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