Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea

Phase 4

Completed

• Conditions: Dysmenorrhea
• Interventions: Drug: tramadol; Drug: paracetamol

• Registration Number: NCT03509740
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-04-17
• Study Start: 2018-04-25
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-26
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-14
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tramadol	tramadol	Intravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes.
paracetamol	paracetamol	Intravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes.

Primary Outcome Measures

Name	Time	Method
acute pain of dysmenorrhea measured by visual analogue scale	15 minutes	Change in visual analogue scale at 15th minutes from baseline
pain of dysmenorrhea measured by visual analogue scale	60 minutes	Change in visual analogue scale at 60th minutes from baseline

Secondary Outcome Measures

Name	Time	Method
Rescue drug need	30 minutes.	the need for additional analgesic drug
adverse effects.	60 minutes	nausea, Vomiting, epigastric pain

Trial Locations

Locations (1)

Aljazeerah Hospital; 🇪🇬 Giza, Egypt