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Comparison of efficacy and safety of "Midazolam Syrup" versus" PO Midazolam " in dental treatment of uncooperative 4-6 years old patients.

Protocol summary

Summary
Dental fear and behavior management problems are the main barriers of noncompliance with dentistry.The prevalence is about 5-20% and 14% respectively In such patients who can not cooperate with dentist, sedation by the means of Pharmacological domain is an alternative. Among sedative drugs in pediatric dentistry, Midazolam due to its safety and appropriate efficacy has gained considerable attention.The purpose of present study is : 1/ to compare the safety and efficacy of Midazolam syrup with PO Midazolam(as an Iranian drug formulation with lower drug price) and 2/ To determine Dental fear, General anxiety and different aspects of child's personality as well as the relationship between above mentioned factors and sedative response. Method and material: 82 uncooperative children (Frankl 1,2) aged 4 to 6 years will randomly receive one of drug prescriptions blindly. Children with hypertrophic tonsils /adenoids (Brodsky>2), more than 24kg, History of allergy to Benzodiazepines, Sleep apnea will be excluded. The behavior will be appraised according to North Carolina Behavior rating score. Dental fear, General anxiety and different aspects of child's personality will be assessed by means of CFSS-DS, SDQ and Conner's parental rating scale, which are completed by mothers.Dental treatment will be initiated 30 minutes after drug administration. Physiological parameters will be evaluated before and during the course of treatment every 15 minutes. These parameters are include SPO2, Heart rate, Respiratory rate and Blood pressure. Child's behavior will be evaluated by means of North Carolina Behavior rating score during injection, cavity preparation and restoration by one practitioner.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201302031861N4
Registration date: 2013-02-08, 1391/11/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-02-08, 1391/11/20
Registrant information
Name
Katayoun Salem
Name of organization / entity
Tehran Azad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2258 0966
Email address
nastaranegar@gmail.com
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Guilan University of Medical Sciences and Main Researcher's personal expense.
Expected recruitment start date
2013-01-02, 1391/10/13
Expected recruitment end date
2013-05-03, 1392/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of "Midazolam Syrup" versus" PO Midazolam " in dental treatment of uncooperative 4-6 years old patients.
Public title
Evaluation of Midazolam Efficacy and Safety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Uncooperative behavior (Frankl 1,2); age 4 to 6 years; ASA I Exclusion criteria: Hypertrophic tonsils /adenoids (Brodsky>2); weight >24 kg; History of allergy to Benzodiazepines; Sleep apnea; history of common cold/ Respiratory disease during the past two weeks.
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences, Deputy of Research and Technology
Street address
Gaz Square, West Shahid Beheshti blvd, Opposite Sepah Bank
City
Rasht
Postal code
41938-93345
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
3910354611

Health conditions studied

1

Description of health condition studied
Anxiety, Uncooperation in Pediatric Dental Treatment
ICD-10 code
F93.1
ICD-10 code description
Phobic anxiety disorder of childhood

Primary outcomes

1

Description
Sedation
Timepoint
Sedation: At the time of injection, cavity preparation and restoration
Method of measurement
By the means of North Carolina Behavior Rting Scale

2

Description
Physiological parameters(Systoic and diastolic Blood pressure), Heart rate, Respiratory rate, SPO2
Timepoint
Before drug administration, at the onset of treatment, and then every 15 minutes
Method of measurement
Blood pressure:Digital blood pressure cuff,Heart rate: pulse oximeter, Respiratory rate: counting the breathing movements of thorax, SPO2: Pulseoximeter

Secondary outcomes

1

Description
Dental fear, General Anxiety, Child's personality (different aspects)
Timepoint
Before treatment
Method of measurement
Questionnaires: CFSS-DS, SDQ, Conner's parental rating scale

Intervention groups

1

Description
Intervention: PO midazolam 2.5 mg/ml Control: mdazolam surup Amsed 2.5 mg/ml
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Guilan Dental Polyclinic
Full name of responsible person
Sara Ataee, Dental nurse,
Street address
Imam blvd, Opposite Pardis Hotel, Polyclinic of Dental School
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences, Deputy of Research and Technology
Full name of responsible person
Ms Komaiee
Street address
Gaz Sq. West Shahid Beheshti blvd, Opposite Sepah Bank, Deputy of Research
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences, Deputy of Research and Technology
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan Dental School
Full name of responsible person
Katayoun Salem
Position
Assistant professor, member of Dental Research center
Other areas of specialty/work
Street address
Rasht, Lakan Site, Lakan road, After Police station, Guilan University Complex, Dental School
City
Rasht
Postal code
Phone
+98 13 1326 3605
Fax
Email
k_salem@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan Dental School
Full name of responsible person
Katayoun salem
Position
Assistant Professor
Other areas of specialty/work
Street address
Rasht, lakan Site, Dental School
City
Rasht
Postal code
Phone
+98 13 1326 3605
Fax
Email
k_salem@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan Dental school
Full name of responsible person
Katayoun Salem
Position
ssitant professor, Member of research center
Other areas of specialty/work
Street address
Rasht, Lakan site, Dental School
City
Rasht
Postal code
Phone
+98 13 1326 3605
Fax
Email
k_salem@gums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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