Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department
This study will randomly assign emergency department patients seeking treatment for a headache to one of three groups. The first group will receive standard emergency care as determined by the treating physician, the second group will breathe high flow air by facemask for 15 minutes, and the third group will breathe high flow oxygen by face mask for 15 minutes. The patients will be questioned in the beginning of their treatment and at 2, 5, 10, 15 and 30 minutes after it's begun about the intensity of their headache and how much relief they are experiencing from their treatment. Concentration of carbon dioxide exhaled by patients will also be recorded at 0, 2, 5, 10, 15 and 30 minutes. After fifteen minutes, the patients in groups 2 and 3 will continue with standard emergency care, which can include any treatment their physician sees fit. Patients in all three groups will receive a stopwatch in the beginning of their emergency department visit and record the total extent of time their headache will take to resolve.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department|
- Time to Relief (Min) [ Time Frame: study duration ] [ Designated as safety issue: No ]Time to relief is a measure of time reported by a stopwatch the patients were provided in the beginning of the study, which showed elapsed time in minutes for patients to perceive that they no longer had a headache.
- Length of Stay in the Emergency Department(Min) [ Time Frame: Study duration ] [ Designated as safety issue: No ]Length of stay was reported as time elapsed in minutes from subject's arrival as a patient to the Emergency Department to patient's discharge from the Emergency Department.
|Study Start Date:||January 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
No Intervention: Standard therapy
Standard emergency department evaluation and treatment for headache
Placebo Comparator: Medical Air
Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
Biological: Medical Air
Compressed medical air
Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
Thorough description provided in brief summary.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856232
|United States, New Jersey|
|Robert Wood Johnson University Hospital Emergency Department|
|New Brunswick, New Jersey, United States, 08801|
|Principal Investigator:||Boris D Veysman, M.D.||Department of Emergency Medicine, UMDNJ - Robert Wood Johnson Medical School|