A randomized placebo-controlled clinical trial will be done among patients with acute headache in emergency department. Patients with history of lidocaine allergy, skull base fracture, GCS<15, and patients younger than 14yo and patients who received a medication in recent two hours will be excluded. Patients will be divided in two groups randomly .After checking the patients vital signs and taking the demographic data, patients will rate their pain on a 10-centimeter visual analogue scale(VAS) prior to drug administration and at 1, 5, 15 and 30 minutes after the initial dose. Medication is one puff of 10% lidocaine spray or normal saline spray(placebo) intranasally. Then the data will be analyzed between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010712050N1
Registration date:2013-02-13, 1391/11/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-13, 1391/11/25
Registrant information
Name
Mohamadali Jafari Nodushan
Name of organization / entity
Shahid Sadoughi University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1828 4313
Email address
malijafari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2012-12-05, 1391/09/15
Expected recruitment end date
2013-04-20, 1392/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intranasal lidocaine effect for headache relief in patients at emergency department
Public title
Intranasal lidocaine effect for headache relief in patients at emergency department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with headache. Exclusion criteria: 1. History of lidocaine allergy; 2. Skull base fracture; 3. GCS<15; 4. Patients younger than 14yo; 5. Patients who received a medication in recent two hours; 6. Vital Sign instability.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Shahid Bahonar Squar
City
Yazd
Postal code
Approval date
2012-02-18, 1390/11/29
Ethics committee reference number
P/17/1/148517
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
3
Description of health condition studied
headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Pain
Timepoint
prior to and at 1, 5, 15 and 30 minutes after intervention
Method of measurement
Numeric Pain Intensity Scale
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: one puff of 10% lidocaine spray in each nasal cavity
Category
Treatment - Drugs
2
Description
control group: one puff of normal saline spray in each nasal cavity
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid doctor Rahnamoon hospital
Full name of responsible person
Mohamadali jafari, Emergency medicine specialist
Street address
Shahid doctor Rahnamoon hospital, Farrokhi street
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research, Shahid Sadoughi University of medical sciences
Full name of responsible person
Dr Hasan Mozaffari
Street address
Deputy of research, Shahid Sadoughi University of medical science, Shahid Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Shahid Sadoughi 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
Shahid Sadoughi University of medical sciences
Full name of responsible person
Mohamadali Jafari
Position
Physician/Emergency medicine specialist
Other areas of specialty/work
Street address
Shahid Sadoughi University of medical sciences, Shahid Bahonar square
City
Yazd
Postal code
Phone
+98 35 1828 4313
Fax
+98 35 1822 4100
Email
ali_jafari_25@yahoo.com ; malijafari@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of medical sciences
Full name of responsible person
Ali Mellat
Position
Neurologist
Other areas of specialty/work
Street address
Shahid Sadoughi University of medical sciences, Shahid Bahonar squre
City
Yazd
Postal code
Phone
+98 35 1724 0171
Fax
+98 35 1822 4100
Email
ali_mellat@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of medical sciences
Full name of responsible person
Mohamadali Jafari
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Shahid Sadoughi University of medical sciences, Shahid Bahonar squre
City
Yazd
Postal code
Phone
+98 35 1828 4313
Fax
+98 35 1822 4100
Email
ali_jafari_25@yahoo.com ; malijafari@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)