Evaluation the effect of oxygen and acetaminophen on patients with headache.
Design
Clinical trial, without control group, randomized, blinded with a sample size of 168 people
Settings and conduct
At least 168 patients with headache aged 20-70 years old referred to Pursina Hospital of Rasht were divided into two groups with 100% oxygen uptake with apotolic ampoule (acetaminophen), one mg versus only apotropic injection group.
Participants/Inclusion and exclusion criteria
inclusion criteria: All patients aged 20 to 70 are eligible for admission to the emergency room with a major headache complaint.
exclusion criteria: Unwillingness to participate in the plan.
Intervention groups
Group A (acetaminophen + oxygen) and group B (acetaminophen).
Main outcome variables
Study of headache reduction after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038196N1
Registration date:2018-06-02, 1397/03/12
Registration timing:retrospective
Last update:2018-06-02, 1397/03/12
Update count:0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
Amir Hossein Salimi Kordasiabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 361 5549
Email address
hosseininejad.s.mohsen@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2017-11-21, 1396/08/30
Trial completion date
empty
Scientific title
Effect of acetaminophen & high flow oxygen in patients with headache
Public title
Study of the effect of acetaminophen and high flow oxygen In patients with headache
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Headache
The need for admission due to the severity of the headache
Indication of the onset of analgesic treatment for headache
Exclusion criteria:
People under the age of 20 and over 70 years
Patients with CVA history
Signs of fracture of the base of skull
Patients unstable for hemodynamic
Patients admitted with head trauma
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
168
Actual sample size reached:
168
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the study cards are written from numbers 1 to 168 (minimum sample size), then, these cards are named by another person who does not know about interventions as the group A (acetaminophen + oxygen) and group B (acetaminophen).Then, these cards are placed in a box and delivered to another person. Presenter coordinate with the professors of emergency medicine and other emergency medical assistants to randomly take a paper (type A or B) out of the box and the patients receive the treatment that is on the card when the patient is admitted to hospital with the main complaint of the headache.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, the prescribe, as well as the person who analyze the data, do not know the type of treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gilan University of Medical Sciences
Street address
Pursina Hospital-Namjoo Street-Rasht-Gilan
City
Rasht
Province
Guilan
Postal code
1234567890
Approval date
2017-11-17, 1396/08/26
Ethics committee reference number
IR.GUMS.REC.1396.289
Health conditions studied
1
Description of health condition studied
Headache
ICD-10 code
G43.C
ICD-10 code description
Periodic headache syndromes in child or adult
Primary outcomes
1
Description
Pain
Timepoint
At the time of admission and two hours after prescribtion
Method of measurement
Visual Analage Scaling (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
The first group (acetaminophen + oxygen)Receiving oxygen 100% and high pressure (oxygen at a suitable and humid temperature that enters the patient's airway through a face mask) with an Apotel (acetaminophen) injection of one gram
Category
Treatment - Drugs
2
Description
The second group (acetaminophen ): Receiving an Apotel (acetaminophen) injection of one gram
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pursina Hospital
Full name of responsible person
Dr. Sadegh Jafarpour Kooluri
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2444
Fax
+98 13 3333 9842
Email
poursina@gums.ac.ir
Web page address
http://www.gums.ac.ir/poursina
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sadegh Jafarpour keloori
Street address
Pursina Hospital-Namjoo Street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2444
Email
poursina@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Sadegh Jafarpour Kooluri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Pursina Hospital - Namjoo Street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 2444
Email
salimia92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Sadegh Jafarpour Kooluri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Pursina hospital - Namjo street
City
Rasht
Province
Guilan
Postal code
41937-13194
Phone
+98 13 3332 5783
Fax
+98 13 3333 9842
Email
salimia92@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Amir Hossein Salimi
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Minagol.Edalat 97
City
Gorgan
Province
Golestan
Postal code
1234567890
Phone
+98 17 3215 4009
Email
salimia92@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Professors and students of medical universities
Under which criteria data/document could be used
No conditions
From where data/document is obtainable
Using existing mail
What processes are involved for a request to access data/document
If available, the data will be provided to the requested person within 2 months