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NCT Number: NCT03509740

Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea

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

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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aljazeerah Hospital

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol

Drug

100 mg tramadol in 100 ml saline with slow infusion

Paracetamol

Drug

Intravenous 1 gm paracetamol in 100 ml saline with slow infusion

Other names: perfalgan

Primary outcomes

  1. acute pain of dysmenorrhea measured by visual analogue scale

    Time frame: 15 minutes

    Change in visual analogue scale at 15th minutes from baseline

  2. pain of dysmenorrhea measured by visual analogue scale

    Time frame: 30 minutes

    Change in visual analogue scale at 30th minutes from baseline

  3. pain of dysmenorrhea measured by visual analogue scale

    Time frame: 60 minutes

    Change in visual analogue scale at 60th minutes from baseline

Secondary outcomes

  1. Rescue drug need

    Time frame: 30 minutes.

    the need for additional analgesic drug

  2. adverse effects.

    Time frame: 60 minutes

    nausea, Vomiting, epigastric pain

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Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Algazeerah hospital

Registry information

Official study title

Efficacy and Safety of Intravenous Tramadol Versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2018
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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