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Comparison of caudal block, intravenous and suppository acetaminophen preemptive analgesia in pediatric inguinal herniotomy

Protocol summary

Study aim
Election the best analgesic method after inguinal hernia repair surgery in children
Design
Interventional study with a control group of parallel, randomized, double-blind Phase 2-3 using the table of random numbers that were performed on 159 patients
Settings and conduct
This double-blind study is performed on 159 children who are candidates for inguinal hernia repair surgery referred to Akbar Hospital in Mashhad. Patients and the analyzers will be blinded. patients will be divided into 3 groups based on analgesia methods.In the intervention groups, one group is given intravenous acetaminophen and the second is given acetaminophen suppository and the control group is subjected to caudal block and the evaluation of analgesia is performed according to the behavioral-FLACC criteria.
Participants/Inclusion and exclusion criteria
Children aged 6 months to 3 years are candidates for inguinal hernia repair surgery, no history of bupivacaine allergy, no local infection in the spine, no pilonidal cyst, no deformity or lesion in the spine, no history of allergies To acetaminophen, no history of liver problems, no history of heart disease
Intervention groups
Candidate children for inguinal hernia repair surgery who underwent general anesthesia by induction with 1 microgram / kg fentanyl, 3 to 5 mg / kg 1% propofol and 0.5 mg / kg atracurium, intubated, in the first intervention group after induction and before surgery, intravenous acetaminophen 12.5 mg / kg and in the second intervention group 15 mg / kg acetaminophen suppository and in the control group 0.25% bupivacaine block dose at a dose of 1 ml / kg is used, after surgery and extubation, the patient is transferred to recovery and the patient's pain is measured according to the behaivorial-FLACC criterion.
Main outcome variables
The amount of analgesia after surgery in recovery according to the behaivorial-FLACC criteria

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120911010811N2
Registration date: 2022-01-13, 1400/10/23
Registration timing: prospective

Last update: 2022-01-13, 1400/10/23
Update count: 0
Registration date
2022-01-13, 1400/10/23
Registrant information
Name
Alireza Sabzevari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2677
Email address
sabzevaria@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of caudal block, intravenous and suppository acetaminophen preemptive analgesia in pediatric inguinal herniotomy
Public title
Comparison of pediatric intravenous acetaminophen and acetaminophen suppository in hernia surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for inguinal hernia repair surgery Parents' consent based on children's participation in the study Participants are children from 6 months to 3 years
Exclusion criteria:
History of bupivacaine allergy Existence of local infection in the spine Presence of pilonidal cyst History of acetaminophen allergy History of liver problems History of heart disease
Age
From 6 months old to 3 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 159
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants are not aware of the intervention and the type of treatment received . Also, outcome assessors are unaware of how patients are grouped.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committe of Mashhad university of Medical Sciences
Street address
Ghoreyshi Building, Daneshgah street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-11-30, 1400/09/09
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.613

Health conditions studied

1

Description of health condition studied
Patients with inguinal hernia who are candidates for surgery
ICD-10 code
K40
ICD-10 code description
Inguinal hernia

Primary outcomes

1

Description
The amount of analgesia
Timepoint
After inguinal hernia surgery in recovery
Method of measurement
Based on the behaivorial-FLACC criteria

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Children who are candidates for inguinal hernia repair surgery, general anesthesia is performed with 1 mg / kg fentanyl, 3 to 5 mg / kg 1% propofol and 0.5 mg / kg atracurium, the patient is intubated After induction and before surgery, they are placed in a caudal block with 0.25% bupivacaine at a dose of 1 ml / kg. At the end of surgery and extubation, the patient is transferred to recovery and the patient's pain is measured according to the behaivorial-FLACC criterion.
Category
Treatment - Drugs

2

Description
Intervention group: Children who are candidates for inguinal hernia repair surgery: General anesthesia is performed with 1 mg / kg fentanyl, 3 to 5 mg / kg 1% propofol, and 0.5 mg / kg atracurium. The patient is intubated, after induction and before surgery, intravenous acetaminophen is prescribed at 12.5 mg / kg, after the end of surgery and extubation, transferred to recovery and the patient's pain is measured according to the behaivorial-FLACC criterion.
Category
Treatment - Drugs

3

Description
Intervention group: Children who are candidates for inguinal hernia repair surgery: General anesthesia is performed with 1 mg / kg fentanyl, 3 to 5 mg / kg 1% propofol, and 0.5 mg / kg atracurium. The patient is intubated, after induction and before surgery, acetaminophen suppositories are given at a dose of 15 mg / kg, after the end of surgery and extubation, transferred to recovery and the patient's pain is measured according to the behaivorial-FLACC criterion.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Hospital Allergy Clinic
Full name of responsible person
Alireza Sabzevari
Street address
Akbar Hospital, television square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3871 3803
Email
sabzevaria@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghoreishy), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Fax
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Sabzevari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Akbar Hospital, television Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3871 3803
Email
sabzevaria@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Sabzevari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Akbar Hospital, television Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3871 3803
Email
sabzevaria@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Sabzevari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Akbar Hospital, television Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3871 3803
Email
sabzevaria@mums.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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