Comparing Naproxen to Sumatriptan for Emergency Headache Patients (HEDNet2)

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Migraine; Primary Headache Disorder; Tension-type Headache

Treatments: Drug: Naproxen; Drug: Sumatriptan 100 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT00449787

06-11-472

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 401 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated in the emergency department for acute primary headache

Exclusion criteria

• Allergy, intolerance, or contra-indication to one of the study medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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401 participants in 2 patient groups

Sumatriptan

Active Comparator group

Description:

Sumatriptan 100 mg tablet

Treatment:

Drug: Sumatriptan 100 mg

Naproxen

Active Comparator group

Description:

Naproxen 500 mg tablet

Treatment:

Drug: Naproxen