A Clinical Trial to Compare Oral Midazolam and Oral Promethazine Effect as Premedication on Sedation among Uncooperative Children undergoing dental procedures
Aim: Comparing oral midazolam and oral promethazine premedication on child's cooperation before ketamin/Midazolam IV administration in pediatric dentistry.
Material and Method: This unicenter cross-over randomized double blind clinical trial is carried out on 6 children aged 2-6 years referred to the fellowship unit of dental school due to their fear and multiple dental needs. Patients’ selection is based on the following main inclusion criteria: being ASA I or II classification and scored 1 in Frankl Behavior scale and exclusion criteria: no systemic contraindications for sedation; nasal obstruction; respiratory infection; mouth opening limitation; macroglossia; tonsillar hypertrophy. Each patient is scheduled for two subsequent visits to receive one of the two premedications before IV sedation. Each patient will be considered as his/her control (self-control) and patients will randomly be assigns to either intervention group 1 (oral Midazolam as premed in 1st visit and oral Promethazine in 2nd visit) and intervention group 2 (oral Promethazine as the premed in 1st visit and oral Midazolam in 2nd visit) through random number table. Being 6 hours NPO is instructed before sedation. IV Ketamin/Midazolam will be administered half an hour after premedication and following dental treatment will be done. Vital signs will be controlled every 15 minutes as a base before drug administration. Patient’s cooperation for IV sedation is measured using HOUPT scale. Drugs side effects including nausea and vomiting , dizziness and sleepiness will be recorded at the end of sedation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120516106N3
Registration date:2017-10-29, 1396/08/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-29, 1396/08/07
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
Dental Research Center, Research Institute of Dental Sciences, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical Trial to Compare Oral Midazolam and Oral Promethazine Effect as Premedication on Sedation among Uncooperative Children undergoing dental procedures
Public title
Oral Midazolam Vs Oral Promethazine Premedication Effect on Dental Sedation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: uncooperative children aged 2-6 years; completely negative Frankle behavioral scale; ASA I or II for systemic health; two teeth requiring the same treatment in two separate sessions
Exclusion Criteria: any systemic disease with contraindication for sedation or premedication ;nasal obstruction;respiratory infection; mouth opening limitation; macroglossia; tonsillar hypertrophy
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:
26
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 in Biomedical Research, Research Institute of Dental Sciences, Shahid Beheshti Univ
Street address
Ethics committee Office, 5th floor, Research Institute for Dental Sciences, Dental school, Shahid Beheshti University of Medical Sciences, Daneshjoo blvd, Evin
City
Tehran
Postal code
1983663113
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
IR.SBMU.RIDS.REC.21
Health conditions studied
1
Description of health condition studied
dental anxiety and management
ICD-10 code
F00-F99
ICD-10 code description
Mental and behavioural disorders
Primary outcomes
1
Description
Patient's Cooperation for Sedation
Timepoint
At the IV Administration step
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Nausea and vomitting
Timepoint
After the end of treatment and sedation
Method of measurement
Questionair
2
Description
Sleeepiness
Timepoint
After the end of treatment and sedation
Method of measurement
Questionair
3
Description
Dizziness
Timepoint
After the end of treatment and sedation
Method of measurement
Questionair
Intervention groups
1
Description
Intervention group 1 :In 1st session oral Midazolam suspension premedication (0.5mg/kg) is administered half an hour before IV Ketamin (2mg/kg) and IV Midazolam (0.5 mg/kg). Then in 2nd session oral Promethazine (1 mg/kg) is administered half an hour before IV Ketamin (2mg/kg) and IV Midazolam (0.5 mg/kg) administration.
Category
Treatment - Drugs
2
Description
Intervention group 2 : In 1st session oral Promethazine suspension premedication (0.5mg/kg) is administered half an hour before IV Ketamin (2mg/kg) and IV Midazolam (0.5 mg/kg). Then in 2nd session oral Midazolam (1 mg/kg) is administered half an hour before IV Ketamin (2mg/kg) and IV Midazolam (0.5 mg/kg) administration.
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, Shahid Beheshti Medical University,Daneshjoo Blvd, Evin, Chamran Highway
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 Chancellor of Research, 5th Floor, Shahid Beheshti University of Medical Sciences, Daneshjoo blvd, Evin, Chamran Highway
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Position
Professor
Other areas of specialty/work
Street address
Vice Chancellor of Research Offic, 5th Floor, Shahid Beheshti University of Medical Sciences, Daneshjoo blvd, Evin, Chamran Highway
City
Tehran
Postal code
1983963113
Phone
+98 21 2243 9780
Fax
Email
zarghi@sbmu.ac.ir
Web page address
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 of Pediatric Dentistry, Dental School, Shahid Beheshti University of Medical Sciences, Daneshjoo blvd, Evin, Chamran High way
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
Dept of Pediatric Dentistry
Full name of responsible person
Ghassem Ansari
Position
Professor
Other areas of specialty/work
Street address
Dept of Pediatric Dentistry, Dental School, Shahid Beheshti University of Medical Sciences, Daneshjoo blvd, Evin, Chamran High way
City
Tehran
Postal code
1983963113
Phone
+98 21 2225 5958
Fax
+98 21 2225 5537
Email
drgansari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)