Comparing Naproxen to Sumatriptan for Emergency Headache Patients

Study Overview
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Brief Summary
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2/3 of patients discharged from an emergency department after treatment for an acute headache will still be bothered by headache within 24 hours of emergency department (ED) treatment. The goal of this study is to compare two medications, naproxen and sumatriptan, to determine which is better for the treatment of recurrent headache within 24 hours of emergency department discharge.

Detailed Description
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Two-thirds of the five million headache patients who present to US emergency departments (ED) annually are suffering an acute exacerbation of a primary headache disorder. Of these acute primary headaches, migraine is the most frequently encountered disease entity in the ED, accounting for 60% of primary headaches, followed by tension-type headaches, which represent 10% of all primary headaches seen in the ED. About ¼ of all acute primary headaches seen in the ED cannot readily be given a specific diagnosis3. Multiple parenteral treatments are used to treat acute primary headaches1, but to date, regardless of specific headache diagnosis, no medication eliminates the frequent recurrence of headache after ED discharge. To date, it is unknown which medication patients should be given when discharged from an ED after treatment for a primary headache. This study will compare two oral headache treatments to determine which one relives pain more effectively. Specific aims: 1) To determine which of two oral medications is more efficacious for all acute primary headache patients who are discharged from an ED. Primary hypotheses: In the 48 hour period following ED treatment for a primary headache, sumatriptan 100mg will relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale for pain.

Official Title
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A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department (ED)

Conditions
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Migraine, Tension-type Headache, Primary Headache Disorder

Intervention / Treatment
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* Drug: Sumatriptan 100 mg
* Drug: Naproxen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treated in the emergency department for acute primary headache Exclusion Criteria: Allergy, intolerance, or contra-indication to one of the study medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Active Comparator: Sumatriptan<br>Sumatriptan 100 mg tablet | Drug: Sumatriptan 100 mg<br>* Sumatriptan 100mg tablet<br>|
| Active Comparator: Naproxen<br>Naproxen 500 mg tablet | Drug: Naproxen<br>* Naproxen 500mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale | Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable. Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief | Baseline, two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache-related Functional Disability | This is a recommend outcome in headache research. At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities). For this analysis, patient's answers were dichotomized into some impairment or no impairment. | Baseline, two hours | 
| Patient Satisfaction | At the 48 hour assessment, patients were asked, The next time you go to an emergency room with a headache, do you want to receive the same medication. This outcome tabulates the number of affirmative responses. | 48 hours after ER discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency department, headache, migraine