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OpenTrials
Completed

NCT Number: NCT05511155

Oxygen Therapy for Headache

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aksaray University Aksaray Training and Research Hospital

Aksaray, 68200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen therapy

Other

Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.

Primary outcomes

  1. visual analog scale score

    Time frame: 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 outcomes

  1. rescue analgesia

    Time frame: 30 th minutes

    rescue analgesia (yes/no)

  2. length of stay

    Time frame: 0-300 minutes

    length of stay in the emergency department (time in minutes)

  3. duration of a pain

    Time frame: 0-300 minutes

    duration of a pain attack (time in minutes)

  4. readmission

    Time frame: 0-7 days

    readmission to the emergency department within 7 days (yes/no)

Sponsors and collaborators

Lead sponsor

Aksaray University Training and Research Hospital

Other

Registry information

Official study title

Efficacy of Oxygen Therapy in Primary Headache Disorder

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 22, 2022
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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