This double blind clinical trial aims to compare the effect of premedication with hydroxyzine and midazolam on side effects of sedation with intravenous ketamine administration in pediatric dentistry. Twenty 2-6 year-old children are selected among those presenting to dental school clinic using convenience sampling and are randomly divided into two groups (n=10). The parents are briefed about the procedure and written informed consent is obtained from them. The inclusion criteria are ASI class I, two to six years of age, definitely negative or negative Frankl behavioral rating scale and requiring at least two treatment sessions. The exclusion criteria are colds, tonsillar hypertrophy and obesity. In the first session, group one receives 1mg/kg hydroxyzine (protocol A) and group two receives 0.5mg midazolam syrup combined with 0.25mg atropine (protocol B). In the second session, this order is reversed and group one receives protocol B while group two receives protocol A. Upon noticing the signs/symptoms of sedation, patients receive a combination of 0.5mg/kg midazolam and 5mg/kg ketamine intravenously. Dental treatment is commenced 20-30 minutes after drug administration and local anesthesia is induced using 2% lidocaine with 1:80,000 epinephrine. Depth of sedation and children’s behavior are assessed by a blind examiner using Houpt sedation rating scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602291882N8
Registration date:2016-10-24, 1395/08/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-24, 1395/08/03
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
All costs of the project is paid by Dental Research Center, Research Institute of Dental Sciences, Dental School, Shahid Beheshti University of Medical Sciences Tehran, Iran.
Expected recruitment start date
2014-10-02, 1393/07/10
Expected recruitment end date
2015-03-16, 1393/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Midazolam and Hydroxyzine premedication on side effects of Ketamine Intravenous Sedation in Pediatric Dentistry
Public title
Effect of Midazolam and Hydroxyzine premedication on reduction of side effects of Ketamine sedation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Healthy 2-6 years old children؛ Uncooperative negative and definitely ranked as Frankel scale؛ having at least two sessions dental treatment Exclusion criteria: Cold and allergy؛Tonsils hypertrophy more than 50%؛ severe obesity
Age
From 2 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences,Tehran, Iran
Street address
Shahi Beheshti Dental School, Daneshjo Blvd, Evin
City
Tehran
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
21
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Organic anxiety disorder
Primary outcomes
1
Description
Drowsiness
Timepoint
1 hour, 2 hours after sedation and 6 hours after discharge
Method of measurement
Parents observation and report
2
Description
Nausea
Timepoint
1 hour, 2 hours after sedation and 6 hours after discharge
Method of measurement
Parents observation and report
3
Description
Dizziness
Timepoint
1 hour, 2 hours after sedation and 6 hours after discharge
Method of measurement
Parents observation and report
4
Description
Vomit
Timepoint
1 hour, 2 hours after sedation and 6 hours after discharge
Method of measurement
Parents observation and report
Secondary outcomes
1
Description
Conscious sedation
Timepoint
Every 15 minutes
Method of measurement
Houpt scale
2
Description
SpO2
Timepoint
Every 15 minutes
Method of measurement
pulse oxymeter
3
Description
Heart Rate
Timepoint
Every 15 minutes
Method of measurement
pulse oxymeter
Intervention groups
1
Description
Syrup of Hydroxyzine( Kharazmi Phrmaceutic Co., Iran) 1mg/kg as oral and premedication.
Category
Treatment - Drugs
2
Description
Midazolam syrup(Dales Pharmaceutic, England) 0.5 mg/kg+ Atropine(Caspian Pharmaceutic,Iran) 0.25 mg/kg, as oral and premedication.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Shahid Beheshti University of Medical Sciences,Tehran, Iran