A Randomized Trial to Optimize Discharge From the ED After Treatment for Headache

Condition(s) targeted: Migraine; Tension-Type Headache; Primary Headache Disorder

Intervention: Sumatriptan 100mg (Drug); Naproxen (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Montefiore Medical Center

Official(s) and/or principal investigator(s):
Benjamin W. Friedman, MD,MS, Principal Investigator, Affiliation: Albert Einstein College of Medicine of Yeshiva University

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 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.

Official title: Optimizing Discharge From the Emergency Department After Treatment for an Acute Primary Headache: A Randomized Trial of Sumatriptan Versus Naproxen for Recurrent Headache.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Pain intensity score

Secondary outcome:

Adverse effects

Headache-related functional disability

Patient satisfaction

Detailed 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 and which is more efficacious for the subset of headache patients with an acute migraine.

2. To determine the feasibility of grouping all primary headache disorder patients into one category for analysis.

Primary hypotheses:

1A. In the 48 hour period following ED treatment for migraine, sumatriptan 100mg will relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale for pain.

1B. 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.

2. Methodology hypothesis: When compared to those subjects with an acute migraine, "headache" patients who do not meet International Headache Society migraine criteria will demonstrate similar variability in response to treatment.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Treated in the emergency department for acute primary headache

Exclusion Criteria:

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

Montefiore Medical Center, Bronx, New York 10467, United States; Recruiting
Benjamin W. Friedman, MD, MS, Email: befriedm@montefiore.org

Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Niels M Dua, MD, Email: nmdua@aol.com

Starting date: March 2007
Ending date: February 2010
Last updated: February 14, 2009