Intravenous Tramadol Versus Intravenous Paracetamol in Patients With Dysmenorrhea

Study Overview
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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

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.

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

Conditions
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Dysmenorrhea

Intervention / Treatment
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* Drug: tramadol
* Drug: paracetamol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tramadol<br>Intravenous 100 mg tramadol in 100 ml saline with slow infusion over 10 minutes. | Drug: tramadol<br>* 100 mg tramadol in 100 ml saline with slow infusion<br>|
| Active Comparator: paracetamol<br>Intravenous 1 gm paracetamol in 100 ml saline with slow infusion over 10 minutes. | Drug: paracetamol<br>* Intravenous 1 gm paracetamol in 100 ml saline with slow infusion<br>* Other names: perfalgan;|

What is the study measuring?
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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 |