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Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Phase 4

Conditions

Dysmenorrhea

Treatments

Drug: tramadol
Drug: paracetamol

Study type

Interventional

Funder types

Other

Identifiers

NCT03509740
dysmenorrhea

Details and patient eligibility

About

Patients presented with primary dysmenorrhea composed the study population. One gram paracetamol and 100 mg tramadol in 100 ml saline with a slow infusion were compared in ceasing dysmenorrhea in the emergency department

Full description

Patients over 18 years old who presented with dysmenorrhea composed the study population. Patients received painkiller 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 is measured with the visual analogue scale at baseline, 15th and 30th minutes and 1 hour after study drug administration. At the end of the 60 minutes, rescue drug need is also recorded.

Enrollment

100 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with moderate to severe primary dysmenorrhea and visual analog scale (VAS) pain scores ≥40
  • Patients over 18 years old

Exclusion criteria

  • denied to give inform consent, irregular menstrual cycles, known or suspected secondary dysmenorrhea
  • 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 or Alcohol Abuse

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups

tramadol
Experimental group
Description:
Intravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes.
Treatment:
Drug: tramadol
paracetamol
Active Comparator group
Description:
Intravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes.
Treatment:
Drug: paracetamol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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