Objectives: This study aimed to compare the efficacy of premedication with melatonin and oral midazolam in pediatric dental patients.
Design: This non-randomized double blind clinical trial was conducted on 23 uncooperative 2-6 years old with completely negative Frankel behavioral rating scale. Cases in ASA I were included who had no signs of any cold or flu. Children in group I received 0.5mg/kg melatonin orally one hour before the IV induction while group II received 0.5mg/kg oral midazolam 30 minutes prior to the IV induction procedures in their first session. Each child acted as self control receiving the other premedication drug. Sedation was scored using Houpt sedation rating scale. Physiological parameters of blood pressure, heart rate and SPO2 were recorded at start of treatment and in 15 minute intervals in addition to potential side effects including dizziness, nausea, vomiting and sleepiness at 1 and 6 hours of the treatment end. Parental satisfaction rate was recorded beside that of the clinician. This Study is at phase II.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101616106N2
Registration date:2016-12-27, 1395/10/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-27, 1395/10/07
Registrant information
Name
Ghassem Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 5958
Email address
drgansari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
zarghi@sbmu.ac.ir
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of premedication with melatonin versus oral midazolam in pediartic patients
Public title
Efficacy of premedication with melatonin versus oral midazolam in pediartic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Uncooperative chidren aged 2-6 years, completely negative Frankel behavioral scale approved by two pediatric dentists, ASA I for systemic health with at least two teeth requiring treatments like pulpotomy, restoration, stainless steel crown or extraction for two separate dental visits. Exclusion criteria: Any systemic disease with contraindications for sedation or premedication, cold symptoms, nasal obstruction, respiratory infection, limited neck movement, macroglossia, tonsillar hypertrophy, micrognathia, mouth opening limitation, not being able to remain NPO and having less than two teeth requiring the same treatment.
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:
23
Randomization (investigator's opinion)
Not 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
Ethics Committee in Biomedical Research, Research Institute of Dental Sciences Shahid Beheshti Unive
Street address
Office of Ethics, Research Institute for Dental Sciences, 5th floor,Dental school, Shahid Beheshti University of Medical Sciences, Student blvd, Evin
City
Tehran
Postal code
1983663113
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
ir.sbmu.rids.rec.1395.209
Health conditions studied
1
Description of health condition studied
dental anxiety and management
ICD-10 code
V
ICD-10 code description
Mental and behavioural disorders
Primary outcomes
1
Description
sedation
Timepoint
At the IV Administration step
Method of measurement
Houpt scale
Secondary outcomes
1
Description
evaluation of recovery process and medication side effects
Timepoint
After the treatment ends and IV sedation reversed
Method of measurement
Observation and asking parents
Intervention groups
1
Description
"Intervention group: Oral Melatonin tablet of 3 mg was grounded and added to 1cc of sweetened drinking water before being administered an hour prior to the actual IV sedation episode."
Category
Treatment - Drugs
2
Description
"Control group: Oral Midazolam Vial of 5mg was added to 1cc sweetened drinking water before being administered half an hour prior to the actual IV sedation episode."
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghassem Ansari
Street address
Department of Pediatric Dentistry
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Office of Vice Dean of Research, Floor 5, Shahid Beheshti University of Medical Sciences, Student Blvd, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Office of Vice Chancellor of Research, Floor 5, Shahid Beheshti University of Medical Sciences, Student Blvd, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Position
Professor
Other areas of specialty/work
Street address
Vice Chancellor for Research
City
Tehran
Postal code
1983963113
Phone
+98 21 2243 9780
Fax
Email
zarghi@sbmu.ac.ir
Web page address
www.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghassem Ansari
Position
Professor
Other areas of specialty/work
Street address
Dept Pediatric Dentistry
City
Tehran
Postal code
1983963113
Phone
+98 21 2225 5958
Fax
Email
drgansari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghassem Ansari
Position
Professor
Other areas of specialty/work
Street address
Dept of Pediatric Dentistry
City
Tehran
Postal code
1983963113
Phone
+98 21 2225 5958
Fax
Email
drgansari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)