Oxygen in Migraine Treatment

NCT05780671 | Completed

• 1 other identifier: E-66175679-514.05.02-1015712
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine Headache; Oxygen

Outcome Measures

Primary Outcomes (1)

• examine effect of oxygen therapy in pain management of acute migraine attacks in emergency department.

  comprasion of VAS scores

  until December 2023

Secondary Outcomes (1)

• Rate of pain relief and need for additional analgesics were determined as secondary outcomes to be evaluated.

  until december 2023

Study Arms (2)

Oxygen receiving group

patients diagnosed as headcahe related to migraine without aura who received supplemental oxygen together with the standart theraphy

Other: oxygen

standart group

patients diagnosed as headcahe related to migraine without aura who received standart theraphy only.

Interventions

oxygen OTHER

inhaled oxygen 10L/min with face mask for 1 hour

Oxygen receiving group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Ataturk Sanatorium Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Ankara Ataturk Sanatorium TRH

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffesor

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 22, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: April 9, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

TU (1)