Pretreatment with lidocaine can reduce propofol injection pain. The aim of the present study was to assess and compare the efficiency of lidocaine 0.4% and 2% in reducing the incidence and severity of propofol injection pain.
The inclusion criteria were 4-8-years-old children, ASA class I and II, and candidates for elective surgery.
The exclusion criteria were contraindication to use propofol or lidocaine, patients with thrombophlebitis, and analgesics administration 24 hours prior to the operation.
This was a prospective clinical trial on children 4-8 years old candidates for elective surgery in Dr Sheikh Hospital. 100 children's werein this study, they were injected with lidocaine solutions 2% and 4% befor propofol injection. Imئثdiately after propofol injection ,patient's pain evaluation based on VSD (verbal descriptor scale) and NRS (Numeric Rating Scale) using patient's verbal reaction and behavior namely fretting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111208143N1
Registration date:2013-10-26, 1392/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-26, 1392/08/04
Registrant information
Name
Ehsanolah Ghorbanian
Name of organization / entity
Department of Anesthesiology , Faculty of Medicine, Mashhad Unevercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2612
Email address
ghorbaniane891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Researchers and Vice Chancellor for Mashhad Uneversity of Medical Sciences
Expected recruitment start date
2012-10-13, 1391/07/22
Expected recruitment end date
2013-04-11, 1392/01/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Lidocaine volume and concentration on preventing incidence and severity of propofol injection pain
Public title
Effect of Lidocaine on preventing propofol injection pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : 4-8-years-old childrencandidates for elective surgery; American Society of Anesthesia class I and II
exclusion criteria : contraindication to use propofol or lidocaine; patients with thrombophlebitis; analgesics administration 24 hours prior to the operation.
Age
From 4 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
zakaria bulding, between al shahidi and shahid javan square , fakouri aven.zip code9177899191
City
Mashhad
Postal code
9177899191
Approval date
2012-10-13, 1391/07/22
Ethics committee reference number
910155
Health conditions studied
1
Description of health condition studied
injection pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
pain
Timepoint
Immediately
Method of measurement
VSD (verbal descriptor scale) and NRS (Numeric Rating Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Increasing the volume and decreasing drug fixed-dose lidocaine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr sheikh hospital
Full name of responsible person
Dr Alireza Sabzevari
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad Uneversity of Medical Sciences
Full name of responsible person
Dr Alireza Sabzevari
Street address
Department of Anesthesiology ,Emam Reza Hospital
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad Uneversity 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
Mashhad Uneversity of Medical Sciences
Full name of responsible person
Dr Alireza Sabzevari
Position
Anesthesist and Pediatric Anesthesia Fellowship
Other areas of specialty/work
Street address
Emem Reza Hospital
City
Mashhad
Postal code
Phone
+98 80 22712
Fax
Email
sabzevaria@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology
Full name of responsible person
Dr AlirezaSabzevari
Position
Anesthesist and Pediatric Anesthesia Fellowship
Other areas of specialty/work
Street address
Emem Reza Hospital
City
Mashhad
Postal code
Phone
+98 80 22712
Fax
Email
sabzevaria@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiology , Mashhad Uneversity of Medical Siences
Full name of responsible person
Dr Ehsanolah Ghorbanian
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
00
Fax
Email
ghorbaniane891@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)