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A comparative evaluation of pregabalin and midazolam premedication effect on children candidates for dental treatment under general anesthesia

Protocol summary

Study aim
Determining: abundance of anxiety reduction in vein -segregation abundance of a sedative degree before entering the operating room distribution of housing after work until discharge anesthesia complications during recovery average duration of recovery Comparison of the indicators in two groups
Design
Clinical trial, with control group with parallel groups, three -way blind, phase 3, on 70 patients, was used to randomly.
Settings and conduct
This study is a kind of prospective clinical trial of the Three Exercises and the people involved in the study (Dentist/Parent Parent/Parent/Information Registrar) are unaware of which child received medication. The children studied from clients are selected to one of the private dental clinics in Isfahan. Among those who have studied the criterion, they will be out of study, who have a few or or exit criteria.In this study70 children are intervented , the child is 2-6 years old
Participants/Inclusion and exclusion criteria
Inclusion criteria: The child is in the ASA1 or ASA2 group,The child is ranked 1 or 2 in terms of cooperation Criterion Criterion: Failure to cooperate with parenting,The history of epilepsy and any systemic disease of uncontrolled disease,The child has neuropathy pain,Take a benzodiazepine or painkiller or painkillers, The child has a mental or physical disabilities, The child takes the anticoagulant medication, The child has a history of gastrointestinal problems and liver problems, The child has an anesthesia for anesthesia, The child has a history of seizures, a child with teeth that need to be removed
Intervention groups
Children recipients of pregabalin drug as a pre -medication before receiving dental treatment under general anesthesia
Main outcome variables
Pre -pharmaceutical type, nausea and vomiting, heart rate, blood pressure, recovery time, eye opening time, separation anxiety, relaxation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210419051016N4
Registration date: 2023-07-21, 1402/04/30
Registration timing: retrospective

Last update: 2023-07-21, 1402/04/30
Update count: 0
Registration date
2023-07-21, 1402/04/30
Registrant information
Name
Maryam Hajiahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3266 2236
Email address
dr.maryamhajiahmadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative evaluation of pregabalin and midazolam premedication effect on children candidates for dental treatment under general anesthesia
Public title
A comparative evaluation of pregabalin and midazolam premedication effect on children candidates for dental treatment under general anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The child is in the ASA1 or ASA2 group (systemic disease can be confusing). The child is ranked 1 or 2 in terms of cooperation.
Exclusion criteria:
The lack of cooperation of parenting The history of epilepsy and any systemic disease of uncontrolled disease The child has neuropathy pain. Take a benzodiazepine or painkiller or painkillers (taking these drugs can affect the drug). The child has a mental or physical disabilities. The child takes the anticoagulant medication. The child has a history of gastrointestinal problems and liver problems. The child has an anesthesia for anesthesia. The child has a history of seizures. a child with teeth that need to be removed
Age
From 2 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Easy sampling method is used to divide children into two groups of testing and control. To each child is randomly given a number and through the random numbers table, people are divided into two groups
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study is a kind of prospective clinical trial of the Three Exercises and the people involved in the study (Dentist/Parent Parent/Parent/Information Registrar) are unaware of which child received medication. It does.
Placebo
Not 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
Hazarjarib St
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.MUI.RESEARCH.REC.1402.088

Health conditions studied

1

Description of health condition studied
Examining the effect of pregabalin and midazolam as premedication in children candidates for dental treatment under general anesthesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
heart rate
Timepoint
Before work, after piping during work every 30minutes
Method of measurement
With the help of monitor in the operating room

2

Description
blood pressure
Timepoint
Before work, after piping during work every 30minutes
Method of measurement
Blood barometer

3

Description
Recovery duration
Timepoint
When entering recovery until clearance
Method of measurement
watch

4

Description
Time opening eyes
Timepoint
At the end of work
Method of measurement
watch

5

Description
separation anxiety
Timepoint
When separation
Method of measurement
parental separation anxiety scale

6

Description
sedation
Timepoint
start of work
Method of measurement
Sedation score

7

Description
nausea and vomiting
Timepoint
After the child's consciousness
Method of measurement
Nominal variable

8

Description
Pre -medicine type
Timepoint
Before work
Method of measurement
Type of medicine

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the experimental group, the syrup is 100 mg/5ml pregabalin (Sobhan Company, Iran) and is given 5mg/kg as a single dose of half an hour before the vein.
Category
Rehabilitation

2

Description
Control group: Control Group: For the witness group, the Oral Midazolam (Exir Company, Iran) is used as 0.75mg/kg with a volume of 15ml, which is given to the child half an hour before work.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Roozbeh Dental Clinic, Arbab Street, Isfahan, Iran
Full name of responsible person
Dr. Maryam Haji Ahmadi
Street address
School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 338 8334
Email
elaheasna75@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam HajiAhmadi
Street address
School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 338 8334
Email
elaheasna75@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Dr. Maryam HajiAhmadi
Position
Assistant Professor, University faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 118 9573
Email
dr.maryamhajiahmadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam HajiAhmadi
Position
Assistant Professor, University faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 118 9573
Email
dr.maryamhajiahmadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam HajiAhmadi
Position
Assistant Professor, University faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry of Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 118 9573
Email
elaheasna75@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data obtained from patients related to the results of the study are shared after non -identification
When the data will become available and for how long
Access to the study results of 6 months to one year after printing results
To whom data/document is available
The data obtained from the study will be available for academic individuals related to medical sciences.
Under which criteria data/document could be used
Perform additional analysis on the results subject to the permission of the original project executive
From where data/document is obtainable
Email Address: Dr.Maryamhajiahmadi@gmail.com
What processes are involved for a request to access data/document
The applicant must submit his application by email with the main executor of the project
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