Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509740
• Other study ID #: dysmenorrhea
• Status: Completed
• Phase: Phase 4
• Start date: April 25, 2018
• Est. completion date: October 20, 2018

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 20, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• tramadol
100 mg tramadol in 100 ml saline with slow infusion
• paracetamol
Intravenous 1 gm paracetamol in 100 ml saline with slow infusion

Locations

Country	Name	City	State
Egypt	Aljazeerah Hospital	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Algazeerah hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute pain of dysmenorrhea measured by visual analogue scale	Change in visual analogue scale at 15th minutes from baseline	15 minutes
Primary	pain of dysmenorrhea measured by visual analogue scale	Change in visual analogue scale at 30th minutes from baseline	30 minutes
Primary	pain of dysmenorrhea measured by visual analogue scale	Change in visual analogue scale at 60th minutes from baseline	60 minutes
Secondary	Rescue drug need	the need for additional analgesic drug	30 minutes.
Secondary	adverse effects.	nausea, Vomiting, epigastric pain	60 minutes