Oxygen Therapy for Headache

Completed

• Conditions: Primary Headache Disorder
• Interventions: Other: Oxygen therapy

• Registration Number: NCT05511155
• Lead Sponsor: Aksaray University Training and Research Hospital

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Primary Completion: 2022-08-31
• Status Verified: 2022-09
• Study Completion: 2022-09-30
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
O-8	Oxygen therapy	8 lt/min oxygen
O-15	Oxygen therapy	15 lt/min oxygen
A-8	Oxygen therapy	8 lt/min room air
A-15	Oxygen therapy	15 lt/min room air

Primary Outcome Measures

Name	Time	Method
visual analog scale score	0-60 minutes	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".

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aksaray University Aksaray Training and Research Hospital; 🇹🇷 Aksaray, Turkey