Evaluation of preventive effect of injection paracetamol and lidocaine in reducing pain caused by intravenous injection of propofol in children aged 4 to 6 years
Comparison of preventive effect of injection paracetamol and lidocaine in reducing pain caused by intravenous injection of propofol in children aged 4 to 6 years
Design
A randomized, Triple-blinding clinical trial, with the parallel groups, Phase 3 on 90 patients
Settings and conduct
In this randomized three-blind randomized clinical trial study, 90 children candidate for inguinal surgery under general anesthesia with propofol presented at Imam Hossein Hospital in Isfahan will be included in the study and will be randomly divided into 3 groups. One minute before anesthesia with propofol, patients in the first group will receive paracetamol, in the second group lidocaine and in the third group normal saline. Then the agitation score, pain score and hemodynamic parameters of the patients will be evaluated and compared between the three groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include children 4-6 years, having the American Association of Anesthesiologists (ASA) I and II, candidate for surgery under general anesthesia with propofol. Exclusion criteria include having underlying diseases (including liver, cardiovascular, neurological, metabolic disease, dermatitis), and having drug allergies.
Intervention groups
Intervention group 1: Patients in this group are injected with 1 mg / kg intravenous paracetamol one minute before propofol administration. Intervention group 2: Patients in this group are injected with 1% lidocaine 1 mg / kg one minute before propofol administration. Control group: Patients in this group are injected with 2 cc of normal saline one minute before propofol administration.
Evaluation of preventive effect of injection paracetamol and lidocaine in reducing pain caused by intravenous injection of propofol in children aged 4 to 6 years
Public title
Evaluation of preventive effect of injection paracetamol and lidocaine in reducing pain caused by intravenous injection of propofol in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 4-6 years
Has the American Association of Anesthesiologists (ASA) One and Two
Candidate for inguinal surgery under general anesthesia with propofol
Exclusion criteria:
Has underlying diseases (including liver, cardiovascular, neurological, metabolic disease, dermatitis)
Having drug allergies
Age
From 4 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 90 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into three groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the three study groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, paracetamol, lidocaine, and placebo are prepared by the pharmacist and placed in coded packages, and delivered daily to an anesthesiologist, who prescribes them without knowing the type of each drug. Also, the person recording the patient's clinical information and the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.MUI.MED.REC.1399.1155
Health conditions studied
1
Description of health condition studied
Inguinal surgery
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Pain score
Timepoint
During injection of propofol
Method of measurement
Behavioral scale derived from the Face, Leg, Activity, Cry, Consolability (FLACC)
2
Description
Agitation score
Timepoint
During injection of propofol
Method of measurement
According to Richmond criteria
3
Description
Mean Arterial Pressure
Timepoint
Before and one minute after the intervention
Method of measurement
Monitoring device
4
Description
Hear rate
Timepoint
Before and one minute after the intervention
Method of measurement
Monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group are injected with 1 mg / kg intravenous paracetamol one minute before propofol administration.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in this group are injected with 1% lidocaine 1 mg / kg one minute before propofol administration.
Category
Treatment - Drugs
3
Description
Control group: Patients in this group are injected with 2 cc of normal saline one minute before propofol administration.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital in Isfahan
Full name of responsible person
Sedighe Shah-Hosseini
Street address
Imam Khomeini street
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
nasrin20ir@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sedigheh Shah-Hosseini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
nasrin90ir@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sedigheh Shah-Hosseini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
nasrin90ir@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Setareh Rafiean
Position
General Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology; Al-Zahra Hospital; Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
rafiean@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD