Oxygen Therapy for Headache

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Oxygen Therapy in Primary Headache Disorder

Conditions
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Primary Headache Disorder

Intervention / Treatment
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* Other: Oxygen therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| O-15<br>15 lt/min oxygen | Other: Oxygen therapy<br>* Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.<br>|
| O-8<br>8 lt/min oxygen | Other: Oxygen therapy<br>* Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.<br>|
| A-15<br>15 lt/min room air | Other: Oxygen therapy<br>* Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.<br>|
| A-8<br>8 lt/min room air | Other: Oxygen therapy<br>* Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale score | primary endpoint is the relative reduction in visual analog scale (a psychometric response scale) score in the placebo versus oxygen group to determine whether there was a difference between the high-flow and mid-flow therapies. visual analog scale scaled from 0-100 points with 0 meaning no pain and 100 points meaning worst possible pain. | 0-60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rescue analgesia | rescue analgesia (yes/no) | 30 th minutes | 
| length of stay | length of stay in the emergency department (time in minutes) | 0-300 minutes | 
| duration of a pain | duration of a pain attack (time in minutes) | 0-300 minutes | 
| readmission | readmission to the emergency department within 7 days (yes/no) | 0-7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygen therapy, migraine, emergency department, cluster type headache