Clinical trial NCT05780671: Oxygen in Migraine Treatment
Official title: The Effectiveness of Supplemental Oxygen Therapy in Patients Receiving Acute Migraine Treatment in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Headache
Oxygen
Lead sponsor: Ankara Ataturk Sanatorium Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


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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Primary outcomes:
measure: examine effect of oxygen therapy in pain management of acute migraine attacks in emergency department.
timeFrame: until December 2023
Secondary outcomes:
measure: Rate of pain relief and need for additional analgesics were determined as secondary outcomes to be evaluated.
timeFrame: until december 2023
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Ankara Ataturk Sanatorium TRH
Study officials:
References: