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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03509740

Enrollment

100

Registered

2018-04-26

Start date

2018-04-25

Completion date

2018-10-20

Last updated

2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea

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.

Interventions

DRUGtramadol

100 mg tramadol in 100 ml saline with slow infusion

DRUGparacetamol

Intravenous 1 gm paracetamol in 100 ml saline with slow infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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	30 minutes	Change in visual analogue scale at 30th minutes from baseline

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026