Intravenous Fluids in Benign Headaches Trail
| Status: | Recruiting |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 10 - 65 |
| Updated: | 6/14/2018 |
| Start Date: | May 16, 2017 |
| End Date: | May 2019 |
| Contact: | Wesley J Forred, RN |
| Email: | wesley.forred@umcsn.com |
| Phone: | 702-224-7124 |
Intravenous Fluids in Benign Headaches Trail: A Randomized Single Blind Clinical Trial
Migraine headache has a 1-year period prevalence in the US of 11.7% and accounts for
approximately 1.2 million migraine visits to US emergency departments per year . There are
numerous studies that discuss treatment for migraine and other benign headaches within the
emergency department (ED), however, there are very few that discuss specifically the use of
intravenous fluids (IVF) for headache treatment. Many of these studies look at various
options for treating migraine and other benign headaches: treatment options include dopamine
antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics
and ergot derivatives. Comparisons have been done between many of these treatment options
with dopamine antagonists appearing to be the most effective, compared to other treatments
The dopamine antagonist with the most evidence and availability for benign headaches is
prochlorperazine. Given that IVF administration is a common part of treatment regimen for
benign headache patients in the emergency department and given the lack of randomized trials
in adults, the investigators aim to study the use of IVF on pain reduction in headache
patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF
may help in patients with migraines, whereas the adult literature has no randomized control
trials and a review of data shows that fluids do not help relieve pain in migraine headache
patients. This study will include both adult and pediatric patients presenting to the
Emergency Department with complaint of benign headache.
approximately 1.2 million migraine visits to US emergency departments per year . There are
numerous studies that discuss treatment for migraine and other benign headaches within the
emergency department (ED), however, there are very few that discuss specifically the use of
intravenous fluids (IVF) for headache treatment. Many of these studies look at various
options for treating migraine and other benign headaches: treatment options include dopamine
antagonists, opioids, non-steroid anti-inflammatory drugs (NSAIDs), triptans, anti-epileptics
and ergot derivatives. Comparisons have been done between many of these treatment options
with dopamine antagonists appearing to be the most effective, compared to other treatments
The dopamine antagonist with the most evidence and availability for benign headaches is
prochlorperazine. Given that IVF administration is a common part of treatment regimen for
benign headache patients in the emergency department and given the lack of randomized trials
in adults, the investigators aim to study the use of IVF on pain reduction in headache
patients in the adult ED. There has been one randomized trial in pediatrics that shows IVF
may help in patients with migraines, whereas the adult literature has no randomized control
trials and a review of data shows that fluids do not help relieve pain in migraine headache
patients. This study will include both adult and pediatric patients presenting to the
Emergency Department with complaint of benign headache.
This will be a single center, prospective, single blinded randomized controlled trial on a
convenience sample of patients presenting to the adult or pediatric ED with a chief complaint
of headache. Subjects will only be enrolled when a physician or research assistant who is
familiar with the study protocol is available to enroll patients. Written, informed consent
will be obtained from each patient. Consent will include a discussion of the risks and
benefits. In addition to parental informed consent in the pediatric population, age
appropriate verbal assent will be obtained from pediatric subjects. After 30 minutes, the
treating provider will be permitted to administer a "rescue medication" of their choice for
further treatment. If there is an untoward event that requires the patient to know which IVF
dose was administered, patient will unblinded and will not continue in the study.
convenience sample of patients presenting to the adult or pediatric ED with a chief complaint
of headache. Subjects will only be enrolled when a physician or research assistant who is
familiar with the study protocol is available to enroll patients. Written, informed consent
will be obtained from each patient. Consent will include a discussion of the risks and
benefits. In addition to parental informed consent in the pediatric population, age
appropriate verbal assent will be obtained from pediatric subjects. After 30 minutes, the
treating provider will be permitted to administer a "rescue medication" of their choice for
further treatment. If there is an untoward event that requires the patient to know which IVF
dose was administered, patient will unblinded and will not continue in the study.
Inclusion Criteria:
1. Age 10 to 65 years
2. Temperature less than 100.4 F
3. Normal neurologic exam and normal mental status
Exclusion Criteria:
1. Pregnant
2. Meningeal signs are present
3. Acute angle closure glaucoma is suspected
4. Head trauma within the previous two weeks
5. Lumbar puncture within the previous two weeks
6. Thunderclap onset of the headache
7. Known allergy to one of the study drugs
8. History of intracranial hypertension
9. Is a prisoner
10. Patient declined informed consent
11. Non-English speaking patient or parent/guardian for pediatric patients
12. Attending provider excludes patient
13. Severe Dehydration
We found this trial at
1
site
1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
(702) 383-2000
Phone: 702-383-7336
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