Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-25

Study Completion Date

2018-10-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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tramadol

Intravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes.

Group Type EXPERIMENTAL

tramadol

Intervention Type DRUG

100 mg tramadol in 100 ml saline with slow infusion

paracetamol

Intravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes.

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

Intravenous 1 gm paracetamol in 100 ml saline with slow infusion

Interventions

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tramadol

100 mg tramadol in 100 ml saline with slow infusion

Intervention Type DRUG

paracetamol

Intravenous 1 gm paracetamol in 100 ml saline with slow infusion

Intervention Type DRUG

Other Intervention Names

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perfalgan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No