Comparison of sedative effect of syrup of midazolam and injectable midazolam (as oral) on behavior of 3-6 years old uncooperative children in dentistry
The aim of this study is comparison of sedative effect of the syrup midazolam and injectable midazolam as oral on 3-6 years old uncooperative children under dental treatment.This double blind cross over clinical trial is done on 20 children 3-6 years old referred to dental school. The samples according to inclusion criteria: healthy children as ASA1 classification; uncooperative negative and definitely negative as Frankle scale and exclusion criteria: cold; allergy and tonsil hypertrophy are divided into two groups randomly. After obtaining informed written consent, orally and written instructions before conscious sedation, at first meeting the one group receive combination of 0.5 mg/kg syrup midazolam +1 mg/kg hydroxyzine (regimen A) and the other group receive combination of 0.5 mg/kg injectable midazolam with fruit juice as oral+ 1 mg/kg hydroxyzine (regimen B). In the second session, the first group receive regimen B and the second group B receives regimen A. Dental treatment starts by a pedodontist who is blind to type of regimen 20-30 minutes after drug administration and lidocaine 2% with adrenaline 1/100000 anesthesia. Sedation level and the child's behavior based on Houpt scale evaluates by a member of teamwork who does not aware of the type of regimen. Arterial blood oxygen saturation (SpO2) and heart rate (HR) by finger pulse oxymeter before administration, starting, every 15 minutes during the work, after work and discharge patients records in related form.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406171882N5
Registration date:2016-02-25, 1394/12/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-25, 1394/12/06
Registrant information
Name
Masoud Fallahinejad Ghajari
Name of organization / entity
Facualty of Dentistry, Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3010
Email address
masfalnegh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-07-06, 1392/04/15
Expected recruitment end date
2014-01-05, 1392/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sedative effect of syrup of midazolam and injectable midazolam (as oral) on behavior of 3-6 years old uncooperative children in dentistry
Public title
Effectiveness of oral and injectable midazolam on children behavior in dentistry
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Healthy 3-6 years old children as ASA1 classification؛ Uncooperative negative and definitely negative according to Frankle scale؛ Having at least two sessions of dental treatment
Exclusion criteria: Cold and allergy؛ Tonsils hypertrophy more than 50%; Severe obesity
Age
From 3 years old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Randomization is carried with the toss of a coin.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti Dental School, Daneshjo Blvd, Evin
City
Tehran
Postal code
Approval date
2013-09-04, 1392/06/13
Ethics committee reference number
19
Health conditions studied
1
Description of health condition studied
Fear and anxiety
ICD-10 code
F00-F01-F0
ICD-10 code description
Organic, including symptomatic, mental disorders
Primary outcomes
1
Description
Conscious sedation
Timepoint
Every 15 minutes
Method of measurement
Houpt scale
Secondary outcomes
1
Description
SpO2
Timepoint
Every 15 minutes
Method of measurement
pulse oximeter
2
Description
Heart Rate
Timepoint
Every 15 minutes
Method of measurement
pulse oximeter
Intervention groups
1
Description
0.5 mg/kg Syrup of Midazolam(Amsed, England) +1 mg/kg Hydroyzine(Abureyhan, Iran).
Waiting time for sedation 20 to 30 minute. Treatment time: 30 minute