Intravenous Fluids in Benign Headaches Trail

• Status: Completed
• Trial end date: 2019-05-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center of Southern Nevada
• Treatments: Diphenhydramine; Prochlorperazine; Promethazine

Criteria

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