Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea

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

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

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea
• Intervention / Treatment: Drug: tramadol; Drug: paracetamol

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Aljazeerah hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tramadol; Intravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes.	Drug: tramadol; 100 mg tramadol in 100 ml saline with slow infusion
Active Comparator: paracetamol; Intravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes.	Drug: paracetamol; Intravenous 1 gm paracetamol in 100 ml saline with slow infusion; Other Names: perfalgan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute pain of dysmenorrhea measured by visual analogue scale	Change in visual analogue scale at 15th minutes from baseline	15 minutes
pain of dysmenorrhea measured by visual analogue scale	Change in visual analogue scale at 30th minutes from baseline	30 minutes
pain of dysmenorrhea measured by visual analogue scale	Change in visual analogue scale at 60th minutes from baseline	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue drug need	the need for additional analgesic drug	30 minutes.
adverse effects.	nausea, Vomiting, epigastric pain	60 minutes

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Algazeerah hospital
• Investigators: Study Director: AHMED SAMY, MD, Cairo University; Principal Investigator: mahmoud alalfy, MD, National Research Center; Principal Investigator: Ahmed Ali, mbbch, Faculty of Medicine Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 20, 2018

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 14, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Tramadol
• Other Study ID Numbers: Dysmenorrhea

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No