Comparison of intra nasal lidocaine 10% & lidocaine 5% for headache relief in head trauma patients referring to emergency department
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This randomized double blind randomized clinical trial (RCT), eighty patients with head trauma had a complaints headache, provided that they did not have a Exclusion Criteria , in two groups of 40 A and B. After obtaining informed consent, group A received 5% Lidocaine Intra Nasal Spray and 10% Lidocaine Intra Nasal Spray for headache. Patients' satisfaction and possible side effects were recorded in the checklist for demographic information, vital signs, severity of headache (NRS) before the administration of the drug, and then at 5, 15, 30, and 1 hour after administration of the drug.
Participants/Inclusion and exclusion criteria
inclusion Criteria;Head trauma patients who do not have a Exclusion Criteria;Exclusion Criteria;Patients aged less than 18 years and over 60 years;Reduced level of consciousness;Instability of vital signs; Lidocaine sensitivity;Symptoms of the fracture of the skull base; Pregnancy and lactation; Bleeding and nasal congestion; Cold symptoms or sinusitis;History of seizure;Patients who have received medication within the last two hours during the current headache and are improving.
Intervention groups
Lidocaine 5% nasal spray was applied to group A and 10% nasal lidocaine spray spray was applied to group B.
Main outcome variables
Determine Comparison& the mean of severity of headache types in the lidocaine group of 10%& 5% lidocaine group at 0,5,15, 30,60 minutes after the start: Determining and comparing patients' satisfaction with treatment in the lidocaine group of 5% and 10%
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181103041539N1
Registration date:2018-12-23, 1397/10/02
Registration timing:registered_while_recruiting
Last update:2018-12-23, 1397/10/02
Update count:0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
Fatemeh Tabatabaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3833 5990
Email address
f.tabatabaei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intra nasal lidocaine 10% & lidocaine 5% for headache relief in head trauma patients referring to emergency department
Public title
Comparison of intra nasal lidocaine 10% & lidocaine 5% for headache relief in head trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with head trauma who do not have an Exclusion Criteria
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The sprays are sealed in two seals with the names A and B, and the mediator, in such a way as not to be aware of the drug type, prescribes a spray A or B according to a randomized table.
Blinding (investigator's opinion)
Double blinded
Blinding description
After reassuring the eligibility of the criteria for entering the study and obtaining the informed consent of the patient before receiving the drug, the vital signs of the drug during the current headache and the severity of headache were recorded by the Numeric pain scale for the headache by the assessor. After examination of the nasal cavity, if the nasal hole is open, 5% or 10% lidocaine sprays are injected into the nasal spray of a puff in each nasal cavity at the maximum depth by the trained nurse. Sprays are already in indistinguishable coverage and are numbered A and B in such a way that the mediator is not aware of the type of drug and are prescribed to the specimens identified by the accident pattern.
Placebo
Not 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
yazd,School of Medicine- Shahid Sadoughi University of Medical Sciences
City
yazd
Province
Yazd
Postal code
8915173149
Approval date
2017-02-15, 1395/11/27
Ethics committee reference number
IR.SSU.MEDICINE.REC.1395.347
Health conditions studied
1
Description of health condition studied
head trauma
ICD-10 code
R51
ICD-10 code description
Headache
Primary outcomes
1
Description
Headache score for patients
Timepoint
Headache score for patients with head trauma at 0, 5, 15, 30 and 60 minutes after medication administration
Method of measurement
numeric pain rating scale
Secondary outcomes
1
Description
Patient Satisfaction
Timepoint
After an hour of medication administration
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: Group A administered 5% lidocaine spray administered intranasal.
Category
Treatment - Drugs
2
Description
Control group: Group B administered 10% lidocaine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahnamoun hospital
Full name of responsible person
Fatemeh Tabatabaei
Street address
Farokhi Ave,Shahid Rahnamoun Hospital
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 8111
Fax
+98 35 3312 3005
Email
f.tabatabaei@ssu.ac.ir
2
Recruitment center
Name of recruitment center
Shahid sadoughi hospital
Full name of responsible person
Fatemeh tabatabaei
Street address
Safaeieh, Shahid sadoughi hospital
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
f.tabatabaei@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Sadoughi Blv
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
F.tabatabaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Tabatabaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No 20, Pasdaran Blv, 9 th
City
Yazd
Province
Yazd
Postal code
8916884120
Phone
+98 35 3833 5990
Email
F.tabatabaei@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Alireza Esmaeeli
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Paramedical University
City
Abarkooh
Province
Yazd
Postal code
8915173149
Phone
+98 35 3822 9264
Email
Alirezaesmaeili1@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Tabatabaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No.20, Pasdaran Blvd, 9 th
City
Yazd
Province
Yazd
Postal code
8916884120
Phone
+98 35 3833 5990
Email
f.tabatabaei@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available