This study evaluate intranasal lidocaine efficacy in patients pain relief with primary headache. Subjects are patients with primary headache presenting to ED (emergency department) diagnosed migrane (with or without aura) , cluster or tension by IHS criteria. Patients are devided in two group ,blindly.case group receive nasal lidocaine, other group receive intranasal normal saline as placebo ,and outcome evaluate by rating pain reduction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212289148N2
Registration date:2014-10-11, 1393/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-11, 1393/07/19
Registrant information
Name
Hassan Barzegari
Name of organization / entity
Golestan Hospital
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3079
Email address
barzegari-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundi Shapur University Of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intranasal lidocaine to reduce pain in patients with primary headaches
Public title
Effect of intranasal lidocaine in primary headaches pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients presenting to ED (emergency department)by headache ,diagnosed migrane(with or without aura)or cluster or tension headache,defined by IHS criteria.
exclusion criteria: patients who have intranasal lidocaine administration,hemoglobin oxygen saturation below 90%,fever,meningismus,pregnant or lactating patients,recent head trauma ,sizing within last 24 hours,analgesic use within last 2 hours
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Technology Department of Ahwaz Jondishapur Univercity Of Medical
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Postal code
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
U-91159
Health conditions studied
1
Description of health condition studied
headache
ICD-10 code
R51
ICD-10 code description
headache
2
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
pain
Timepoint
30 minute after treatment
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
lidocaine 2% , 1mg , nasally
Category
Treatment - Drugs
2
Description
normal saline 0.9 %, 1cc , nasally
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
golestan hospital of ahwaz
Full name of responsible person
Street address
City
ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jondishapur Univercity Of Medical Sciences
Full name of responsible person
Ahwaz Jondishapur Univercity Of Medical Sciences
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jondishapur Univercity 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
Ahwaz Jondishapur Univercity Of Medical Sciences
Full name of responsible person
Dr. Hassan Barzegari
Position
Emergency Medicine Specialist / Assistant Professor
Other areas of specialty/work
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 1374 3079
Fax
Email
h_b1979@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondishapur Univercity Of Medical Sciences
Full name of responsible person
Dr Hassan Barzegari
Position
Emergency Medicine Specialist /Assistant Professor
Other areas of specialty/work
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 1374 3079
Fax
Email
h_b1979@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jondishapur Univercity Of Medical Sciences
Full name of responsible person
Dr. Hassan Barzegari
Position
Emergency Medicine Specialist /Assistant Professor
Other areas of specialty/work
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 1374 3079
Fax
Email
h_b1979@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)