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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
rwjms-ed, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00856232
First received: March 4, 2009
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
Results First Received: June 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Headache
Interventions: Biological: Medical Air
Biological: Oxygen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Therapy Standard emergency department evaluation and treatment for headache
Air at 15L/Min Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
Oxygen Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache

Participant Flow:   Overall Study
    Standard Therapy     Air at 15L/Min     Oxygen  
STARTED     26     29     36  
COMPLETED     26     29     36  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Standard Therapy Standard emergency department evaluation and treatment for headache
Air at 15L/Min Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
Oxygen Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
Total Total of all reporting groups

Baseline Measures
    Standard Therapy     Air at 15L/Min     Oxygen     Total  
Number of Participants  
[units: participants]
 		  26     29     36     91  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     NA [1]   NA [1]   NA [1]   unknown  
>=65 years     NA [1]   NA [1]   NA [1]   unknown  
Gender  
[units: participants]
 		       
Female     NA [2]   NA [2]   NA [2]   unknown  
Male     NA [2]   NA [2]   NA [2]   unknown  
Region of Enrollment  
[units: participants]
 		       
United States     26     29     36     91  
[1] Age data not collected as part of IRB protocol
[2] gender data not collected as part of IRB protocol



  Outcome Measures
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1.  Primary:   Time to Relief (Min)   [ Time Frame: study duration ]
  Show Outcome Measure 1

2.  Secondary:   Length of Stay in the Emergency Department(Min)   [ Time Frame: Study duration ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limited number of subjects due to difficulty with recruitment  


Results Point of Contact:  
Name/Title: Dr. Boris Veysman
Organization: UMDNJ
phone: 732-235-8717
e-mail: veysmabo@umdnj.edu


No publications provided


Responsible Party: rwjms-ed, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov 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 22, 2013
Health Authority: United States: Institutional Review Board