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comparing 3 different oxygen delivery methods plus intravenous ketorolac on primary headaches in emergency department

Protocol summary

Summary
Objective: comparison of three different Oxygen therapy methods as an adjunctive treatment for primary headaches. Inclusion criteria: age 18 years and above, moderate and severe primary recurrent headaches. Exclusion criteria: suspicious to secondary headache based on attending physician’s judgment, abnormal vital signs, decreased consciousness, NSAIDs contraindication, Focal neurologic finding, mild pain (VAS score: 3 or less). All adult primary headache patients that meet inclusion criteria would be included. Sample size is 136 patients (34 patients for each group).first group will receive 30 mg intravenous Ketorolac + Oxygen 15lit/min through the non-rebreather mask. Second group will receive 30 mg intravenous Ketorolac + 7lit/min oxygen through 60% venture mask, third group will receive 30 mg intravenous Ketorolac + 4lit/min oxygen through nasal cannula, fourth group will receive 30 mg intravenous Ketorolac in the room air. Pain will be assessed by Visual Analog Scale at 0, 15,30,45,60 minutes of admission. The duration of the study is 6 month.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014111619971N1
Registration date: 2015-04-21, 1394/02/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-04-21, 1394/02/01
Registrant information
Name
Ehsan Karimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 3600
Email address
e-karimi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing 3 different oxygen delivery methods plus intravenous ketorolac on primary headaches in emergency department
Public title
Oxygen therapy in headache
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age 18 years and above; moderate and severe primary recurrent headaches. exclusion criteria: suspicious to secondary headaches based on the attending physician's judgment; abnormal vital signs; variation in the level of consciousness;fever; focal neurologic finding;allergy to NSAIDs; History of peptic ulcer diseases or gastrointestinal bleeding; pregnancy; mild pain( Vas score: 3 or less).
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Poursina Street, Keshavarz Boulevard
City
Tehran
Postal code
1417653861
Approval date
2015-04-07, 1394/01/18
Ethics committee reference number
92-04-30-27786-135783

Health conditions studied

1

Description of health condition studied
Headache
ICD-10 code
R51
ICD-10 code description
Headache

Primary outcomes

1

Description
pain score
Timepoint
0,15,30,45,60 min
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
ED length of stay, morphine dosage, recurrencerate
Timepoint
24 hour
Method of measurement
medical document

Intervention groups

1

Description
ketorolac 30 mg IV + o2 15 lit/min with non rebreathing mask.
Category
Treatment - Drugs

2

Description
ketorolac 30 mg IV +o2 7 lit/min with 60% venturi mask
Category
Treatment - Drugs

3

Description
ketorolac 30 mg IV+ o2 4 lit/min nasal
Category
Treatment - Drugs

4

Description
ketorolac 30 mg IV + Room air
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Shariati Hospital
Full name of responsible person
Dr Ehsan Karimi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morteza Saidi
Street address
Poursina Street, Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Karimi
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Poursina Street, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 8490 2719
Fax
Email
e-karimi@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ehsan Karimi
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Poursina Street, Keshavarz Boulevard
City
Tehran
Postal code
Phone
+98 21 8490 2719
Fax
Email
e-karimi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Ehsan Karimi
Position
Assistant Professor of Emergency Medicine
Other areas of specialty/work
Street address
Poursina Street, Keshavarz Boulevard
City
Tehran
Postal code
1417653861
Phone
+98 21 8490 2719
Fax
Email
e-karimi@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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