Oxygen in Migraine Treatment

The Effectiveness of Supplemental Oxygen Therapy in Patients Receiving Acute Migraine Treatment in the Emergency Department

IIn this study, the investigators planned to investigate effectiveness of supplemental oxygen in patients (18-65 years) who were diagnosed as headache related to migraine without aura in the emergency department (ED).

Patients who will be ordered standard migraine therapy (50 mg dexketoprofen and 10 mg metoclopramide HCl in 100 cc normal saline IV) by the physician blind to research, will be evaluated by the researchers before the treatment and patients met the study criteria will be included. Included patients randomly divided to two group, study group will receive supplemental oxygen with face mask for 1 hour.

Patients' visual analog score (VAS) will be measured at 0th, 15th, 30th and 60th minute of treatment. If there will not be a 50% decrease at VAS score from the beginning, patients will be examined again by the physician again. Patients who will be ordered 100 mg tramadol as rescue therapy by the physician, will be continued to observed, VAS scores will be measured at 120th minute again.

To avoid drug related bias, patients who will be ordered any other drug for primary care or rescue treatment other than mentioned above will not be included into the study.

Study Overview

• Status: Completed
• Conditions: Migraine Headache; Oxygen
• Intervention / Treatment: Other: oxygen

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • University of Health Sciences Ankara Ataturk Sanatorium TRH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients admitted to ED due to headache and who had a prior diagnosis of migraine without aura, were the candidates for study. Among those patients who had diagnosed as headache related to migraine without aura according to 2018 criteria of International Headache Society (IHS) with a visual analog scale (VAS) value above "40" at the 0th minute of treatment were included into the study.

Description

Inclusion Criteria:

with their medical history and ED evaluation being diagnosed as migraine related headache according to HIS 2018 classification, having VAS >40 at the beginning of the treatment, accepting to participate patient group who received standard migraine therapy (50 mg dexketoprofen and 10 mg metoclopramide HCl in 100 cc normal saline iIV).

patient who received 100 mg tramadol as rescue therapy

Exclusion Criteria:

Taking any analgesic in 6 hours before admission, patients who were diagnosed with all other types of primary headaches (migraine with aura, migraine status, TTH, trigeminal autonomic cephalgia etc), patients using anticoagulants or have bleeding diathesis, pregnant and breastfeeding patients, patients had fever, patients diagnosed as secondary headaches, patients had focal neurologic findings, patients had heart, liver, or kidney failure, patients had peptic ulcer, patients had chronic obstructive pulmonary disease, patients had acute coronary syndrome, patients who were not stable hemodynamically patients who had history of acute dystonia or akathisia due to metoclopramide.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Oxygen receiving group; patients diagnosed as headcahe related to migraine without aura who received supplemental oxygen together with the standart theraphy	Other: oxygen; inhaled oxygen 10L/min with face mask for 1 hour
standart group; patients diagnosed as headcahe related to migraine without aura who received standart theraphy only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
examine effect of oxygen therapy in pain management of acute migraine attacks in emergency department.	comprasion of VAS scores	until December 2023

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of pain relief and need for additional analgesics were determined as secondary outcomes to be evaluated.	until december 2023

Collaborators and Investigators

• Sponsor: Ankara Ataturk Sanatorium Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: E-66175679-514.05.02-1015712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: all data and statistical analyzes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No