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Evaluation of the effect of local anesthesia for dental treatment of children under general anesthesia on physiologic parameters of the patient and on recovery of the patients

Protocol summary

Study aim
Evaluation of the effect of local anesthesia for dental treatment of children under general anesthesia on physiologic parameters of patient and on recovery of the patients
Design
A clinical trial with a parallel intervention group, double-blind, randomized, random sampling method. 142 patients undergoing general anesthesia under dental treatment (71 patients with local anesthesia during treatment and 71 without it) will be included in the study. After treatment, physiological parameters are recorded in both groups. Also, the duration of postoperative recovery and postoperative pain is assessed by the Alderete criterion.
Settings and conduct
This study will be performed in the pediatric ward of Tehran Dental School. Seventy-one children in need of dental treatment under anesthesia will be injected with anesthesia, and another 71 will not inject with anesthesia. After treatment, clinical symptoms, pain, and recovery time will be recorded. The evaluator and participant in the study are not aware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion: Children who are medically in the ASA I or ASA II category. Children need anesthesia treatment according to the initial examination for dental treatment. Children need pulp therapy and dental veneers in the maxilla. Exclusion: The child or his / her parents are not satisfied with participating in the study. Children with certain medical conditions, such as any systemic disease such as heart disease, kidney disease, allergy to local anesthetics, etc.
Intervention groups
The intervention group included children who were candidates for general anesthesia undergoing dental treatments and underwent local anesthesia during treatment. The control group included children who were not under local anesthesia during treatment.
Main outcome variables
Physiological parameters, recovery time, and amount of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220425054651N1
Registration date: 2022-04-29, 1401/02/09
Registration timing: prospective

Last update: 2022-04-29, 1401/02/09
Update count: 0
Registration date
2022-04-29, 1401/02/09
Registrant information
Name
Mohammad Hassan Hamrah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4279 4500
Email address
hassanhamrah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-06-04, 1401/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of local anesthesia for dental treatment of children under general anesthesia on physiologic parameters of the patient and on recovery of the patients
Public title
The effect of local anesthesia for dental treatment of children on physiologic parameters of patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children who are medically in the ASA I or ASA II category. Children need anesthesia treatment according to the initial examination for dental treatment. Children need pulp therapy and dental veneers in the maxilla.
Exclusion criteria:
The child or his / her parents are not satisfied with participating in the study. Children with certain medical conditions, such as any systemic disease such as heart disease, kidney disease, allergy to local anesthetics, etc.
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 142
Randomization (investigator's opinion)
Randomized
Randomization description
Candidate children for general anesthesia undergoing dental treatment referred to Tehran Dental School will be randomly divided into two intervention groups (local anesthesia during dental treatment) and the control group (without local anesthesia during dental treatment) by the size 43 permutation block method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is two-way blind, and the outcome assessor, data analyst, and study participant are not aware of the type of intervention. The outcome researcher and evaluator are unaware of the randomization of patients to the two groups receiving local anesthesia and not receiving local anesthesia and do not intervene. Vials containing local anesthesia and vials without local anesthesia are prepared in advance by an operating room nurse who is not involved in collecting, analyzing, and evaluating the outcome.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central office of Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-10-30, 1400/08/08
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1400.159

Health conditions studied

1

Description of health condition studied
Dental root caries
ICD-10 code
K02.7
ICD-10 code description
Dental root caries

Primary outcomes

1

Description
Heart rate
Timepoint
Immediately after the start of pulpotomy treatment, at the moment of chamber pulp entry, at the end of coronary pulp removal, and the completion of pulpotomy treatment.
Method of measurement
Heart rate recorder

2

Description
Arterial blood pressure
Timepoint
Immediately after the start of pulpotomy treatment, at the moment of chamber pulp entry, at the end of coronary pulp removal, and the completion of pulpotomy treatment.
Method of measurement
Mercury barometer

3

Description
Arterial oxygen saturation level
Timepoint
Immediately after the start of pulpotomy treatment, at the moment of chamber pulp entry, at the end of coronary pulp removal, and at the completion of pulpotomy treatment.
Method of measurement
Arterial oxygen measuring device

4

Description
End-tidal CO۲
Timepoint
Immediately after the start of pulpotomy treatment, at the moment of chamber pulp entry, at the end of coronary pulp removal, and at the completion of pulpotomy treatment.
Method of measurement
End-tidal CO۲ recorder

5

Description
Recovery time
Timepoint
After surgery
Method of measurement
Time elapsed (minutes)

6

Description
The amount of pain
Timepoint
After recovery
Method of measurement
Alderete Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Children who need dental treatment under general anesthesia and receive local anesthetic lidocaine 2% epinephrine 1: 100,000 at 3 minutes before the start of treatment. They are then treated with a pulpotomy. Physiological parameters and recovery time, and patients' pain are measured and recorded during and after treatment.
Category
N/A

2

Description
Control group: Children who need dental treatment under general anesthesia. They are then treated with a pulpotomy. Physiological parameters and recovery time, and patients' pain are measured and recorded during and after treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Periodontics, School of Dentistry, Tehran University of Medical Sciences and Health Se
Full name of responsible person
Ali Baghalian
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St,Tehran-Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
abaghalian@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmadreza Shamshiri
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St,Tehran-Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
arshamshiri@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ali Baghalian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St,Tehran-Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
abaghalian@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Baghalian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St,Tehran-Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
abaghalian@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Baghalian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tehran University of Medical Sciences, North Karegar St,Tehran-Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Phone
+98 21 4279 4500
Email
abaghalian@sina.tums.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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