1. Home
  2. Approved trials
  3. » فارسی

Comparative study of prophylactic effect of injectable paracetamol and lidocaine on pain caused by intravenous injection of propofol in children 6 to 10 years

Protocol summary

Study aim
Determining and comparing the prophylactic effect of injectable paracetamol and lidocaine on intravenous propofol injection pain in children 6 to 10 years of age under general anesthesia.
Design
Clinical trial with control group, with parallel group, double-blind, randomized, on 90 patients. For randomization, block generation is used by Excel program.
Settings and conduct
This study will be conducted in pediatrics operation room of Isfahan Imam Hossein Hospital. The anesthesia technician who inject the drugs, the person who collect the data and the analyzer will not be informed about the groups of study. After preparation, one minute before propofol injection, we will inject intravenous Pracetamol in Intervention group 1, and we will inject Lidocaine in group 2 , also we will inject 2 cc normal saline in the control group and after 15 seconds propofol will be injected.
Participants/Inclusion and exclusion criteria
Inclusion criteria include children 6 to 10 years old who are candidates for surgery under general anesthesia with propofol. Exclusion criteria: Known liver; heart;neurological disease and a history of any metabolic disease and any drug reactions and drug allergies.
Intervention groups
Intervention group 1: one minute before Propofol injection, we will inject 1 milligram per kilogram Paractamol intravenously. Intervention group 2: one minute before Propofol injection, we will inject 1 milligram per kilogram Lidocaine intravenously. Control group: one minute before Propofol injection, we will inject 2 cc Normal saline intravenously.
Main outcome variables
Pain score, mean arterial pressure, heart rate and agitation rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210403050824N1
Registration date: 2021-07-11, 1400/04/20
Registration timing: prospective

Last update: 2021-07-11, 1400/04/20
Update count: 0
Registration date
2021-07-11, 1400/04/20
Registrant information
Name
ahmad Karimi hasan abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4274 3155
Email address
ahmadkarimi1886@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-21, 1400/04/30
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of prophylactic effect of injectable paracetamol and lidocaine on pain caused by intravenous injection of propofol in children 6 to 10 years
Public title
paracetamol and lidocaine in pain of intravenous propofol
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children 6 to 10 years general anesthesia with propofol ASA1,ASA2
Exclusion criteria:
Known liver disease Known heart disease Known neurological disease History of metabolic disease Drug reactions and allergies
Age
From 6 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence (blocking) is generated by the help of Excel software and blocks of six are used to equalize the three groups so that the intervention groups 1 and 2 or the control of each person included in the study, can be determined randomly and equally. The blocks of six are separated from the samples and placed in the block randomly by the Excel software of group A or B or C. At the end, it is determined which letter represents the intervention group 1 and 2 and which is for the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are prepared by someone outside the research team in the operating room. He equalize their volumes in ready-made syringes with a coating so that its contents are not known. Group codes are then written on the syringes. The anesthetist who inject the drug and the anesthesiologist who collect the data do not know the group's codes. Patients are also unaware of group assignments. The person who is doing the statistical analysis also does not know how the codes have been assigned to the study groups. After completing the analysis, the codes will be opened.
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
Isfahan University of Medical Science., Hezar Jarib Ave., Azadi Sq., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-10-17, 1399/07/26
Ethics committee reference number
IR.MUI.MED.REC.1399.634

Health conditions studied

1

Description of health condition studied
Pain induced by intravenous propofol injection.
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
Patient pain score at baseline and one minute after propofol injection.
Timepoint
At baseline when injecting propofol and one minute after injecting propofol
Method of measurement
Propofol injection pain score based on the patient's motor and verbal response

2

Description
Heart rate at baseline and one minute after propofol administration.
Timepoint
At baseline and one minute after propofol injection
Method of measurement
Saadat Standard monitoring

3

Description
Mean arterial pressure at baseline and one minute after propofol injection.
Timepoint
At baseline and one minute after propofol injection
Method of measurement
Saadat Standard monitoring

4

Description
Patient agitation during propofol injection.
Timepoint
At baseline and one minute after propofol injection
Method of measurement
Richmond Agitation scale

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: All patients have been taken to the operating room then after premedication with 0.1 milligram per kilogram of midazolam, intravenous cannula number 20 have been inserted in non-dominant dorsal veins and 10 cc per kilogram of Ringer's lactate serum will be infused . Then the arm will be held higher than body for one minute to drain the blood. The cuff of the sphygmomanometer will be closed on the same arm and inflates up to 20 mmHg above systolic blood pressure. Then 1 milligram per kilogram of Paracetamol will be injected intravenously and the cuff will be emptied after one minute. Finally 2 milligram per kilogram of Propofol is then injected over 15 seconds. During the intervention we will record the patient's vital signs, Heart Rate, Blood Pressure, and movements and speech rate one minute before injection of Propofol and in the first minute after injection in a questionnaire.
Category
Prevention

2

Description
The second intervention group: All patients have been taken to the operating room then after premedication with 0.1 milligram per kilogram of midazolam, intravenous cannula number 20 have been inserted in non-dominant dorsal veins and 10 cc per kilogram of Ringer's lactate serum will be infused . Then the arm will be held higher than body for one minute to drain the blood. The cuff of the sphygmomanometer will be closed on the same arm and inflates up to 20 mmHg above systolic blood pressure. Then 1 milligram per kilogram of lidocaine 1% will be injected intravenously and the cuff will be emptied after one minute. Finally 2 milligram per kilogram of Propofol is then injected over 15 seconds. During the intervention we will record the patient's vital signs, Heart Rate, Blood Pressure, and movements and speech rate one minute before injection of Propofol and in the first minute after injection in a questionnaire.
Category
Prevention

3

Description
The control group: All patients have been taken to the operating room then after premedication with 0.1 milligram per kilogram of midazolam, intravenous cannula number 20 have been inserted in non-dominant dorsal veins and 10 cc per kilogram of Ringer's lactate serum will be infused . Then the arm will be held higher than body for one minute to drain the blood. The cuff of the sphygmomanometer will be closed on the same arm and inflates up to 20 mmHg above systolic blood pressure. Then 2 cc of normal saline will be injected intravenously and the cuff will be emptied after one minute. Finally 2 milligram per kilogram of Propofol is then injected over 15 seconds. During the intervention we will record the patient's vital signs, Heart Rate, Blood Pressure, and movements and speech rate one minute before injection of Propofol and in the first minute after injection in a questionnaire.ed in a questionnaire.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Children's Hospital
Full name of responsible person
Sedigheh Shahhoseini
Street address
Isfahan Imam Hossein Hospital., Esteghlal Sq., Imam Khomeini st
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
emamhossein_hospital@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo
Street address
Isfahan University of Medical Science., Hezar Jarib st., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3386 6266
Email
research@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
Ahmad Karimi hasan abadi
Position
Intern student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 59,Yasaman Ave., Delgosha St., Najaf Abad
City
Najafabad
Province
Isfehan
Postal code
8517775899
Phone
+98 31 4274 3155
Fax
Email
ahmadkarimi1886@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sedigheh Shahhoseini
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No 6, Pasandidideh Al, East Allameh Amini St
City
Isfahan
Province
Isfehan
Postal code
8156674943
Phone
+98 31 3261 2181
Email
nasrin20ir@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sedigheh Shah Hoseni
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
No.6,Pasandideh Alley,East Allameh Amini St
City
Isfahan
Province
Isfehan
Postal code
8156674943
Phone
+98 31 3261 2181
Email
nasrin20ir@gmail.com

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
Loading...