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 Overview

• Status: Completed
• Conditions: Headache
• Intervention / Treatment: Biological: Medical Air; Biological: Oxygen

Detailed Description

Thorough description provided in brief summary.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08801
      • Robert Wood Johnson University Hospital Emergency Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 _____

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Study duration

Collaborators and Investigators

• Sponsor: University of Medicine and Dentistry of New Jersey
• Investigators: Principal Investigator: Boris D Veysman, M.D., Department of Emergency Medicine, UMDNJ - Robert Wood Johnson Medical School

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: March 4, 2009
• First Submitted That Met QC Criteria: March 4, 2009
• First Posted (ESTIMATE): March 5, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): April 21, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Migraine; Headache; Cephalgia
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Headache
• Other Study ID Numbers: 0220080056