Oxygen in Migraine Treatment

NCT ID: NCT05780671

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-04-09

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Oxygen receiving group

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

oxygen

Intervention Type: OTHER

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.

No interventions assigned to this group

Interventions

oxygen

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

Intervention Type: OTHER

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Ataturk Sanatorium Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

GÜLŞAH ÇIKRIKÇI IŞIK

Associated Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Health Sciences Ankara Ataturk Sanatorium TRH

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-66175679-514.05.02-1015712

Identifier Type: -

Identifier Source: org_study_id