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Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department

This study has been completed.
Information provided by (Responsible Party):
rwjms-ed, Rutgers, The State University of New Jersey Identifier:
First received: March 4, 2009
Last updated: March 23, 2016
Last verified: March 2016
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.

Condition Intervention
Biological: Medical Air
Biological: Oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxygen Therapy for the Treatment of Undifferentiated Headache in the Emergency Department

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Time to Relief (Min) [ Time Frame: 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 Outcome Measures:
  • Length of Stay in the Emergency Department(Min) [ Time Frame: 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.

Enrollment: 91
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Oxygen
Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
Biological: Oxygen
Medical Oxygen

Detailed Description:
Thorough description provided in brief summary.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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 _____
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Please refer to this study by its identifier: NCT00856232

United States, New Jersey
Robert Wood Johnson University Hospital Emergency Department
New Brunswick, New Jersey, United States, 08801
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Principal Investigator: Boris D Veysman, M.D. Department of Emergency Medicine, UMDNJ - Robert Wood Johnson Medical School
  More Information

Responsible Party: rwjms-ed, Assistant Professor, Rutgers, The State University of New Jersey Identifier: NCT00856232     History of Changes
Other Study ID Numbers: 0220080056
Study First Received: March 4, 2009
Results First Received: June 12, 2012
Last Updated: March 23, 2016

Keywords provided by Rutgers, The State University of New Jersey:

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on April 25, 2017