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

NCT00856232 | Completed Results

• 1 other identifier: 0220080056
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Keywords

Headache; Cephalgia; Migraine

Outcome Measures

Primary Outcomes (1)

• 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.

  study duration

Secondary Outcomes (1)

• Length of Stay in the Emergency Department(Min)

  Study duration

Study Arms (3)

Standard therapy

NO INTERVENTION

Standard emergency department evaluation and treatment for headache

Medical Air

PLACEBO COMPARATOR

Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache

Biological: Medical Air

Oxygen

EXPERIMENTAL

Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache

Biological: Oxygen

Interventions

Medical Air BIOLOGICAL

Compressed medical air

Medical Air

Oxygen BIOLOGICAL

Medical Oxygen

Oxygen

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED.

You may not qualify if:

• 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 \_\_\_\_\_

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital Emergency Department

New Brunswick, New Jersey, 08801, United States

Location

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Air; Oxygen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Chalcogens; Elements; Inorganic Chemicals; Gases

Limitations and Caveats

Limited number of subjects due to difficulty with recruitment

Results Point of Contact

• Title: Dr. Boris Veysman
• Organization: UMDNJ

veysmabo@umdnj.edu

732-235-8717

Study Officials

• Boris D Veysman, M.D.

  Department of Emergency Medicine, UMDNJ - Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 5, 2009
• Study Start: January 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 21, 2016
• Results First Posted: May 3, 2013

Record last verified: 2016-03

Locations

US (1)