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Haloperidol for Headache – THE HA Study RCT

June 17, 2020

Written by Meghan Breed

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In patients aged 15 to 55 years with benign headaches, low dose IV haloperidol (2.5mg) improved pain in as little as 30 minutes without significant adverse events such as QT prolongation.

Why does this matter?
Headaches are the fifth leading cause of patients presenting to the emergency department.  An estimated 3.8 million annual visits account for patients over 15 years of age.  While workup in the emergency department for benign headaches is usually minimal, the length of stay tends to be greater than 2 hours as we await patients to report an improvement in pain satisfactory for discharge.

Haldol for headache? Are you saying this is just all in my head?
This was a randomized, double-blind, placebo-controlled trial performed in a single ED comparing administration of 2.5mg IV haloperidol vs placebo (0.9% NaCl) in 118 patient treated for acute, benign headache.  The primary endpoint for this study was pain reduction at 60 minutes. However, a statistically significant improvement in pain was also reported as little as 30 minutes in the haloperidol group (pain scores were documented at 0, 30, 60 and 90 minutes, and at discharge); 34.5% of patients in the treatment group reported >50% reduction in pain at 30 minutes and 63.8% of patients in the treatment group reported >50% reduction in pain at 60 minutes.  Notably, 58.6% of patients treated with haloperidol had resolution of their headache prior to discharge.  If patients did not have at least a 50% reduction in visual analog scale (VAS) at the 60-minute interval, rescue medications were administered (IV ketorolac or IV metoclopramide).  Only 18 patients (31%) in the haloperidol group required rescue therapy as opposed to 48 patients (78.3%) of the placebo group.  At 24-hours post discharge, fewer patients treated with haloperidol had return of symptoms, and approximately 75% requested haloperidol in the future!  Although this was a small study, the data is promising and haloperidol could certainly be incorporated into our treatment of benign headaches.  We could use this in conjunction with other commonly used treatments such as acetaminophen, ketorolac, and IV fluid, which would allow us to avoid potentially sedating medications such as prochlorperazine (somnolence was not observed in the treatment group).

Important exclusion criteria: abnormal blood pressure (>200/100mmHg), sudden or rapid onset, fever, pregnancy, acute trauma, history of brain mass, history of stroke, history of abnormal brain anatomy, QT>450ms, abnormal neurologic exam, GCS<15, or any other clinical concern warranting head CT.

Treatment of Headache in the Emergency Department: Haloperidol in the Acute Setting (THE-HA Study): A Randomized Clinical Trial. J Emerg Med. 2020 May 10;S0736-4679(20)30349-8. doi: 10.1016/j.jemermed.2020.04.018. Online ahead of print.

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