Protocol summary

Study aim
Determining the difference in sedation effect of midazolam and intranasal ketamine in preoperative pediatric hernioraf surgery at Bouali Hospital in Sari in 1399-1400
Design
Random Allocation Clinical Trial with Parallel, Double-Blind, Randomized Phase 3 Groups on 36 Patients Random Allocation is used for randomization
Settings and conduct
Children one to six years old undergoing herniorafi surgery in Buali Hospital, Sari. The method of administration is midazolam (0.5 mg / kg) or ketamine (5 mg / kg)The researcher, who has no information about the type of drug, is given intranasally to the child half an hour before the procedure in the pre-treatment room, due to the double-blindness.
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Age 1 to 6 years, physical condition according to the American Society of Anesthesia 1 or 2 (ASA PA), having informed consent of parents to participate in the study, patients who have a negative history of taking sedatives or analgesics in the past 24 hours, Patients with normal liver enzymes. , Patients who are normal in terms of psychological diseases, have food and drug allergies. Exclusion criteria: Allergy to any of the drugs used in premedication or during surgery, having any hemodynamic disorders, those with respiratory problems during surgery and airway disease The upper extremities are irritated like a cold. , Parental dissatisfaction.
Intervention groups
Group of midazolam (0.5 mg / kg) intranasal and other group of ketamine (5 mg / kg) intranasal
Main outcome variables
Degree of children's relaxation, behavioral assessment, their heart rate, ease of separation from parents and their satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210904052371N2
Registration date: 2021-10-26, 1400/08/04
Registration timing: registered_while_recruiting

Last update: 2021-10-26, 1400/08/04
Update count: 0
Registration date
2021-10-26, 1400/08/04
Registrant information
Name
Goli Aezi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 9875
Email address
gaezi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-17, 1400/07/25
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison sedation effect of intranasal ketamine and midazolam in premedication of child herniorrhaphy surgery
Public title
The comparison sedation effect of intranasal ketamine and midazolam in premedication of child herniorrhaphy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 1 to 6 years Physical condition according to the American Society of Anesthesia 1 or 2 (ASA PA) Having the informed consent of the parents to participate in the study Patients who have a history of sedative or analgesic use in the past 24 hours Patients with normal liver enzymes Patients who are normal in terms of psychological diseases They have no food or medicine allergies
Exclusion criteria:
Allergy to any of the drugs used in premedication or during surgery Having any hemodynamic disorders People who have respiratory problems during surgery and irritable upper airway disease such as colds Parental dissatisfaction
Age
From 1 year old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment process is blockade and the Random Allocation software used to block 6 blocks of 6 has been created. Both drugs are colorless and the nurse in charge of preparing the drugs in syringes A and B fills in the anesthesia assistant according to the randomization block. Random letters A and B are injected into the child without knowing the type of medicine, and also the person who performs sedation and analgesia and evaluates the child's behavior is completely unaware of the type of medicine. Then the person doing the sedation and pain assessment and assessing the child's behavior was also completely unaware of the type of medication.
Blinding (investigator's opinion)
Double blinded
Blinding description
For bilateral blindness, patients are divided into two groups of 18 people. Half an hour before the procedure, one group of midazolam (0.5 mg / kg) intranasal and the other group of ketamine (5 mg / kg) intranasal in the syringe without the name of the drug is prescribed. Becomes. The degree of sedation, behavioral assessment, heart rate, ease of separation from parents and their satisfaction are reviewed and recorded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Approval date
2021-09-29, 1400/07/07
Ethics committee reference number
IR.MAZUMS.REC.1400.475

Health conditions studied

1

Description of health condition studied
The degree of sedation of the drug
ICD-10 code
Y47
ICD-10 code description
Sedatives, hypnotics and antianxiety drugs

Primary outcomes

1

Description
relaxation
Timepoint
The beginning of anesthesia until the end of anesthesia
Method of measurement
Ramsay Sedation Scale

2

Description
Behavioral evaluation
Timepoint
The beginning of anesthesia until the end of anesthesia
Method of measurement
Visual Analogue Scale

3

Description
heart beat
Timepoint
The beginning of anesthesia until the end of anesthesia
Method of measurement
monitor

4

Description
Ease of separation from parents
Timepoint
The beginning of anesthesia until the end of anesthesia
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
nausea and vomiting
Timepoint
End of Anesthesia Tick hours after anesthesia
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
Intervention group: Midazolam (0.5 mg / kg) is given intranasally to a child half an hour before the procedure in a pre-treatment room by a researcher who has no knowledge of the type of drug due to bilateral blindness.
Category
Treatment - Drugs

2

Description
Intervention group:Ketamine (5mg / kg) is given intranasally to a child half an hour before the procedure in a pre-treatment room by a researcher who has no knowledge of the type of drug due to bilateral blindness.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Bu Ali Sina Hospital
Full name of responsible person
Hamid Reza Efati
Street address
Pasdaran Boulevard, Bu Ali Sina Hospital
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
HamidRezaEfati5@gmail.com
Web page address
Https://www.mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saedi
Street address
Moalem Ave
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
m.saedi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hamidreza Efati
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani St., Imam Khomeini Hospital, Sari
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
hamidrezaefati5@gmail.com
Web page address
https://www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Goli Azzi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani St. Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
Gaezi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Goli Aezi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani St., Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
Gaezi@mazums.ac.ir
Web page address
https://www.mazums.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
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
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