Oxygen Therapy for Headache

Sponsor

Aksaray University Training and Research Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05511155

Collaborator

(none)

132

Enrollment

Location

Anticipated Duration (Months)

44.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Headache Disorder	Other: Oxygen therapy

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 Design

Study Type:

Observational

Actual Enrollment :

132 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

Efficacy of Oxygen Therapy in Primary Headache Disorder

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.