Status:
COMPLETED
Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Conditions:
Headache
Eligibility:
All Genders
21+ years
Phase:
NA
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 treatin...
Detailed Description
Thorough description provided in brief summary.
Eligibility Criteria
Inclusion
- All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED.
Exclusion
- 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 \_\_\_\_\_
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00856232
Start Date
January 1 2009
End Date
May 1 2011
Last Update
April 21 2016
Active Locations (1)
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1
Robert Wood Johnson University Hospital Emergency Department
New Brunswick, New Jersey, United States, 08801