Migraine, Tension-type Headache, Primary Headache Disorder
Conditions
Keywords
Emergency department, headache, migraine
Brief summary
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
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.
Interventions
Sumatriptan 100mg tablet
DRUGNaproxen
Naproxen 500mg tablet
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Treated in the emergency department for acute primary headache
Exclusion criteria
* Allergy, intolerance, or contra-indication to one of the study medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale | Baseline, two hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache-related Functional Disability | Baseline, two hours | 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. |
| Patient Satisfaction | 48 hours after ER discharge | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sumatriptan Sumatriptan 100 mg tablet | 203 |
| Naproxen Naproxen 500 mg tablet | 198 |
| Total | 401 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not require medication | 95 | 92 |
| Overall Study | Lost to Follow-up | 10 | 8 |
Baseline characteristics
| Characteristic | Sumatriptan | Naproxen | Total |
|---|---|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 10 | 35 years STANDARD_DEVIATION 10 | 36 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 173 Participants | 168 Participants | 341 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 97 | 18 / 97 |
| serious Total, serious adverse events | 0 / 98 | 0 / 98 |
Outcome results
Primary
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
Time frame: Baseline, two hours
Population: After discharge from the emergency room, some patients had headache requiring use of medication and some did not. Only those patients who took the investigational medication were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sumatriptan | Numerical Rating Scale | 4.1 units on a scale | Standard Deviation 3.1 |
| Naproxen | Numerical Rating Scale | 4.3 units on a scale | Standard Deviation 3 |
Secondary
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.
Time frame: Baseline, two hours
Population: Patients who reported any level of functional impairment (mild, moderate, or severe) are tabulated here.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sumatriptan | Headache-related Functional Disability | 41 participants |
| Naproxen | Headache-related Functional Disability | 36 participants |
Secondary
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.
Time frame: 48 hours after ER discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sumatriptan | Patient Satisfaction | 69 participants |
| Naproxen | Patient Satisfaction | 68 participants |