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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey
- University of Health Sciences Ankara Ataturk Sanatorium TRH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
-
Study Plan
How is the study designed?
Design Details
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
|
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.
Time Frame: until December 2023
|
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.
Time Frame: until december 2023
|
until december 2023
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-66175679-514.05.02-1015712
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.