High-Flow Oxygen for Treatment of Cluster Headache: A Randomized Trial | Headache | JAMA | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 18.207.108.182. Please contact the publisher to request reinstatement.
[Skip to Navigation Landing]
Original Contribution
December 9, 2009

High-Flow Oxygen for Treatment of Cluster Headache: A Randomized Trial

Author Affiliations

Author Affiliations: Headache Group, Institute of Neurology, The National Hospital for Neurology and Neurosurgery, Queen Square London, England (Drs Cohen, Burns, and Goadsby); and Department of Neurology, University of California, San Francisco, San Francisco (Dr Goadsby).

JAMA. 2009;302(22):2451-2457. doi:10.1001/jama.2009.1855
Abstract

Context Cluster headache is an excruciatingly painful primary headache syndrome, with attacks of unilateral pain and cranial autonomic symptoms. The current licensed treatment for acute attacks is subcutaneous sumatriptan.

Objective To ascertain whether high-flow inhaled oxygen was superior to placebo in the acute treatment of cluster headache.

Design, Setting, and Patients A double-blind, randomized, placebo-controlled crossover trial of 109 adults (aged 18-70 years) with cluster headache as defined by the International Headache Society. Patients treated 4 headache episodes with high-flow inhaled oxygen or placebo, alternately. Patients were randomized to the order in which they received the active treatment or placebo. Patients were recruited and followed up between 2002 and 2007 at the National Hospital for Neurology and Neurosurgery, London, England.

Intervention Inhaled oxygen at 100%, 12 L/min, delivered by face mask, for 15 minutes at the start of an attack of cluster headache or high-flow air placebo delivered alternately for 4 attacks.

Main Outcome Measures The primary end point was to render the patient pain free, or in the absence of a diary to have adequate relief, at 15 minutes. Secondary end points included rendering the patient pain free at 30 minutes, reduction in pain up to 60 minutes, need for rescue medication 15 minutes after treatment, overall response to the treatment and overall functional disability, and effect on associated symptoms.

Results Fifty-seven patients with episodic cluster headache and 19 with chronic cluster headache were available for the analysis. For the primary end point the difference between oxygen, 78% (95% confidence interval, 71%-85% for 150 attacks) and air, 20% (95% confidence interval, 14%-26%; for 148 attacks) was significant (Wald test, χ25 = 66.7, P < .001). There were no important adverse events.

Conclusion Treatment of patients with cluster headache at symptom onset using inhaled high-flow oxygen compared with placebo was more likely to result in being pain-free at 15 minutes.

Trial Registration isrctn.org Identifier: ISRCTN94092997

×