NCT05780671Completed
Oxygen in Migraine Treatment
The Effectiveness of Supplemental Oxygen Therapy in Patients Receiving Acute Migraine Treatment in the Emergency Department
Source: ClinicalTrials.gov · Last updated 11 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 160 (actual)
- First submitted
- 13 Mar 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Diseases
- Migraine
- NCT number
- NCT05780671
What you commit to
- Study type: Observational
- Participants enrolled: 160
- From 1 Jun 2023 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- \-
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Health Sciences Ankara Ataturk Sanatorium TRH Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.