Comparison of anesthetic effects of lidocaine injected with jet injecor with lidocaine injected with needele and sirynge in lumbar puncture in patients admitted to Shariati and Imam Khomeini Hospital
Objective: To evaluate effectiveness of needle free injection of lidocaine via Jet injectore device to induce analgesia in lumbar puncture.
Inclusion criteria: All of patients who are candidate for lumbar puncture and are above 18 years old and also sign consent form enrolled in the study.
Exclusion criteria: unwilling of patients to participate in the study and also relative or absolute contraindication of lumbar puncture such as; in site infection, coagulative disorders, ICP rising and etc. are main exclusion criteria of the study.
Study population: All patients who come to emergency department of Shariati and Imam Khomeni Hospitals and are candidate for lumbar puncture.
Sample size: Considering of confidence interval 99%, power 90% we need to 22 patients in each group of the study. Standard deviation for patients= 5.5 ± 3.2 and controls= 2.5 ± 1.9.
Interventions: This is a single blinded clinical trial and patients randomly assigned to case or control groups. In cases, patients receive o.5 cc lidocainte 2% via Jet injector and in controls they receive 3- 4 cc lidocane 2% via syringe to introduce local analgesia. Physician performs lumbar puncture after inducing of analgesia lumbar. In both groups pain level of patients after inducing analgesia and performing lumbar puncture evaluate with Numerical Rating Scale by investigators.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407048872N4
Registration date:2014-07-24, 1393/05/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-24, 1393/05/02
Registrant information
Name
Morteza Saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2719
Email address
m_saeedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-07-21, 1393/04/30
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anesthetic effects of lidocaine injected with jet injecor with lidocaine injected with needele and sirynge in lumbar puncture in patients admitted to Shariati and Imam Khomeini Hospital
Public title
local anesthetic effect of lidocaine in lumbar puncture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age > 18; clinical indication of lumbar puncture. Exclusion criteria: in site infection; coagulative disorders; ICP rising; decrease level of consciousness; mass lesion in brain CT scan; lidocaine sensitivity; moderate to severe pain; uncooperative patients; unwilling to participation; severe renal and hepatic disfunction.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not 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
Qods street, keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-04-08, 1393/01/19
Ethics committee reference number
37/130/د/93
Health conditions studied
1
Description of health condition studied
local anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
pain evaluation
Timepoint
After local anesthesia, After performing lumbar puncture
Method of measurement
Neumeric Rating Scale
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
After termination of Procedure
Method of measurement
beck questionary
2
Description
Physician satisfaction
Timepoint
After termination of procedure
Method of measurement
Beck questionarry
Intervention groups
1
Description
In intervention group, each patient receives o.5 cc lidocaine 2% via Jet injector. The device hold 0.5 cm above the skin of injection site and then lidocaine inject to induce of analgesia.
Category
Treatment - Devices
2
Description
In controls 3- 4 cc lidocaine 2% inject via syringe in lumbar puncture site. The rest of procedure will done in both group as routine and completely similar.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Morteza Saeedi
Street address
North Amirabad street
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Majid Hajimaghsoudi
Street address
East Bagherkhan street, Chamran highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh Basti
Street address
Building No 1, North entrance door of Tehran University, Poursina sreet, Qods street, Enghelab street
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
Dr Majid H ajimaghsoudi
Position
assistant professor/ Emergeny Medicine specialist
Other areas of specialty/work
Street address
Imam Khomeini Hospital, East Bagherkhan street, Chamran highway
City
Tehran
Postal code
1411713135
Phone
+98 21 6990 4848
Fax
+98 21 8863 3039
Email
hajimaghsoudi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Morteza Saeedi
Position
Assistant professor/ Emergency Medicine specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2719
Fax
+98 21 8863 3039
Email
m_saeedi@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
Morteza Saeedi
Position
Assistant professor/ Emergency Medicine specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2719
Fax
+98 21 8863 3039
Email
m_saeedi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)