Headache
Conditions
Keywords
Headache, Cephalgia, Migraine
Brief summary
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.
Detailed description
Thorough description provided in brief summary.
Interventions
BIOLOGICALMedical Air
Compressed medical air
BIOLOGICALOxygen
Medical Oxygen
Sponsors
University of Medicine and Dentistry of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED.
Exclusion criteria
* patients who need immediate oxygen after triage: Recent fire or carbon monoxide exposure\_\_\_\_\_\_\_ O2 saturation 94% or less on room air on triage vitals \_\_\_\_\_\_ patient arrives on supplemental oxygen\_\_\_\_\_\_\_ patient reports shortness of breath\_\_\_\_\_\_\_ * patients in whom 100% oxygen is contraindicated, potentially undesirable, or controversial: history of COPD\_\_\_\_\_\_\_ possible cardiac ischemia (mouth / jaw / neck / shoulder / chest / abdomen pain or pressure)\_\_\_\_\_\_\_ possible stroke (new focal weakness or numbness, speech, hearing or vision deficit, bowel or bladder incontinence or retention)\_\_\_\_\_ * patients unable to tolerate the gas treatment: patient not able to tolerate a face mask\_\_\_\_\_\_\_ patient requests immediate treatment with another preferred therapeutic agent\_\_\_\_\_\_\_ * treating physician or nurse request to discontinue the study at any point\_\_\_\_\_\_\_ * patients who have diminished decision-making capacity history of mental retardation or pervasive developmental disorder\_\_\_\_\_\_\_ patient not awake and alert\_\_\_\_\_\_\_ patient not oriented to self, month and year, and current location\_\_\_\_\_\_\_ patient unwilling or unable to fully participate in the research associate interview and consent process\_\_\_\_\_\_\_ * patients who are at risk for intracranial hemorrhage history of intracranial aneurythm, hemorrhage, surgery, or tumor\_\_\_\_\_\_\_ current headache began after trauma\_\_\_\_\_\_\_ current headache began after using elicit drugs\_\_\_\_\_\_\_ * patients who are at high risk for intracranial infection fever \> 100.4 F on triage vitals\_\_\_\_\_\_\_ complaining of recent onset neck stiffness\_\_\_\_\_\_\_ * patients who are at high risk for extracranial head pathology ear pain or drainage\_\_\_\_\_\_\_ tooth or gum pain\_\_\_\_\_\_\_ headache localized to a skin lesion on the head\_\_\_\_\_\_ * patient is potentially critically ill active bleeding from any source\_\_\_\_\_\_\_ heart rate \<60 or \>130 on triage vitals\_\_\_\_\_\_\_ systolic blood pressure \<90 or \>180 on triage vitals\_\_\_\_\_\_\_ respiratory rate \< 10 or \>30 on triage vitals\_\_\_\_\_\_\_ * patient is younger than 21\_\_\_\_\_\_\_ * patients who know or suspect they are pregnant \_\_\_\_\_
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relief (Min) | study duration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay in the Emergency Department(Min) | Study duration | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Therapy Standard emergency department evaluation and treatment for headache | 26 |
| Air at 15L/Min Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache | 29 |
| Oxygen Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache | 36 |
| Total | 91 |
Baseline characteristics
| Characteristic | Standard Therapy | Air at 15L/Min | Oxygen | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | NA participants | NA participants | NA participants | NA participants |
| Age, Categorical Between 18 and 65 years | NA participants | NA participants | NA participants | NA participants |
| Region of Enrollment United States | 26 participants | 29 participants | 36 participants | 91 participants |
| Sex: Female, Male Female | NA Participants | NA Participants | NA Participants | NA Participants |
| Sex: Female, Male Male | NA Participants | NA Participants | NA Participants | NA Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 29 | 0 / 36 |
| serious Total, serious adverse events | 0 / 26 | 0 / 29 | 0 / 36 |
Outcome results
Primary
Time to Relief (Min)
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.
Time frame: study duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Therapy | Time to Relief (Min) | 92.2 Minutes | Standard Deviation 84.4 |
| Medical Air at 15L/Min | Time to Relief (Min) | 83.9 Minutes | Standard Deviation 45.3 |
| Oxygen at 15 L / Min | Time to Relief (Min) | 35.4 Minutes | Standard Deviation 29.8 |
Secondary
Length of Stay in the Emergency Department(Min)
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.
Time frame: Study duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Therapy | Length of Stay in the Emergency Department(Min) | 177.5 Minutes | Standard Deviation 109 |
| Medical Air at 15L/Min | Length of Stay in the Emergency Department(Min) | 210.7 Minutes | Standard Deviation 134.9 |
| Oxygen at 15 L / Min | Length of Stay in the Emergency Department(Min) | 118.7 Minutes | Standard Deviation 145.8 |