Clinical trial NCT05511155: Oxygen Therapy for Headache
Official title: Efficacy of Oxygen Therapy in Primary Headache Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Headache Disorder
Keywords: oxygen therapy
migraine
emergency department
cluster type headache
Lead sponsor: Aksaray University Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients had one to six headache attacks per month which were started before 50 years old and were present for more than one year.

Brief summary: Headache is one of the common causes of emergency department admissions and constitutes approximately 2%. Although the exact mechanism is not clear, It is known that high-flow oxygen therapy is effective in headache treatment. There are limited studies related to the use of oxygen therapy in headaches and its derivatives in the literature. In this study, the investigators aimed to compare the high and medium flow oxygen therapies with placebo in primary headache disorders.

Detailed description: Four different treatment methods were determined; 1) high-flow oxygen (15lt/min oxygen), 2) medium-flow oxygen (8lt/min oxygen), 3) high-flow room air as placebo (15 lt/min room air), 4) medium-flow room air as placebo (8 lt/min room air). All four treatment methods will be applied to all patients included in the study. One of the four treatments will be randomly applied at each separate ED admission with a gap of 1 week or more in between. This randomization will be performed by a computer at the time of admission. A study nurse will administer the patient's therapy according to the computer's current decision for 15 minutes. Patients and treating physicians will be blinded to the selected therapy. After 15 minutes of the end of treatment (at the 30th minute of the start of treatment), the treating physician will ask patients if they need rescue analgesia and analgesia will be administered if necessary. Additional analgesia is at the discretion of the treating physician. Patient data, including demographics, medical history, and findings of a physical examination performed before and after therapy will be recorded by the treating physician.

Eligibility criteria: Inclusion Criteria:

* age 18-55 years
* frequent attacks of primary headache disorders according to International Headache Society (IHS) criteria

Exclusion Criteria:

* secondary headache disorders
* oxygen-dependent chronic illnesses such as chronic obstructive pulmonary disease
* a history of cerebrovascular disease
* pregnancy
* active smokers or living with a smoker.

Primary outcomes:
measure: visual analog scale score
timeFrame: 0-60 minutes
Secondary outcomes:
measure: rescue analgesia
timeFrame: 30 th minutes
measure: length of stay
timeFrame: 0-300 minutes
measure: duration of a pain
timeFrame: 0-300 minutes
measure: readmission
timeFrame: 0-7 days
Other outcomes:
Locations:
city: Aksaray
country: Turkey
facility: Aksaray University Aksaray Training and Research Hospital
Study officials:
References:
citation: Friedman BW, Grosberg BM. Diagnosis and management of the primary headache disorders in the emergency department setting. Emerg Med Clin North Am. 2009 Feb;27(1):71-87, viii. doi: 10.1016/j.emc.2008.09.005.
citation: Roberto G, Raschi E, Piccinni C, Conti V, Vignatelli L, D'Alessandro R, De Ponti F, Poluzzi E. Adverse cardiovascular events associated with triptans and ergotamines for treatment of migraine: systematic review of observational studies. Cephalalgia. 2015 Feb;35(2):118-31. doi: 10.1177/0333102414550416. Epub 2014 Sep 22.
citation: Mo H, Chung SJ, Rozen TD, Cho SJ. Oxygen Therapy in Cluster Headache, Migraine, and Other Headache Disorders. J Clin Neurol. 2022 May;18(3):271-279. doi: 10.3988/jcn.2022.18.3.271.
citation: Petersen AS, Barloese MC, Lund NL, Jensen RH. Oxygen therapy for cluster headache. A mask comparison trial. A single-blinded, placebo-controlled, crossover study. Cephalalgia. 2017 Mar;37(3):214-224. doi: 10.1177/0333102416637817. Epub 2016 Jul 11.