A Comparison of 2 Oral Sedation Regimens: Hydroxyzine-Midazolam and Hydroxyzine -Meperidine with oral Hydroxyzine-submucosal Meperidine in Dental Sedation of uncooperative 2-6 years of age children
Aim: To compare efficacy and safety of 3 sedation regimens . Study design: Randomized, double blind with controls. Study population: 2-6 years of age uncooperative dental patients, refering to Mofeed Educational hospital and Shaheed Beheshti Dental school. Inclusion criteria: Uncooperative behavior (Frankl 1and 2); Age between 2-6; Health status ASA I. Exclusion criteria: History of allergic reaction to drugs that are using in this study; sleep apnea.
Sample size: 78. Interventions: Group A: Hydroxyzine-Midazolam; Group B: Hydroxyzine-Meperidine.
both A and B are administered via Oral route.
Group C: Oral Hydroxyzine-Submucosal Meperidine.
The patient will be monitored for physiologic parameters every 15 minutes for Heart rate, Blood Pressure, Respiratory rate and SPo2 (Oxygen saturation).
Behavior will be rated according to HOUPT scale at the end of appointment, which evaluates the degree of sleep, movement and crying. Outcomes: Safety (physiologic parameters) and Efficacy (HOUPT scale).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101181861N2
Registration date:2011-04-30, 1390/02/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-30, 1390/02/10
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
The approved research budget
Expected recruitment start date
2010-05-24, 1389/03/03
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of 2 Oral Sedation Regimens: Hydroxyzine-Midazolam and Hydroxyzine -Meperidine with oral Hydroxyzine-submucosal Meperidine in Dental Sedation of uncooperative 2-6 years of age children
Public title
Comparison of Meperidine versus Midazolam Sedation in Uncooperative children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 2-6 years; Behavior: Negative or completely negative according to Frankl rating scale; Health status: ASA I; should have at least 3 consecutive similar treatment sessions. Exclusion criteria: history of allergic reactions to Benzodiazepines or any other drug used in the study; Previous complications with general anesthesia in patient or family; Hyper trophic adenoids in a manner that occupied more than 50% of pharyngeal space (Brodsky 2+>); Sleep apnea.
Age
From 2 years old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
78
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
Research Center of Dental Sciences, Shahid Beheshti University of Medical Sciences
Street address
4th floor, Dental School, Daneshjoo Boulevard, Evin
City
Tehran
Postal code
19832
Approval date
2011-03-13, 1389/12/22
Ethics committee reference number
8910/م.ک.ا/..
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F93.1
ICD-10 code description
Phobic anxiety disorder of childhood
Primary outcomes
1
Description
Sleepness
Timepoint
Once(at the beginning of the treatment)
Method of measurement
Observation
2
Description
Movement
Timepoint
During the process of treatment
Method of measurement
Observation
3
Description
Crying
Timepoint
During the process of treatment
Method of measurement
Observation
4
Description
Overall behavior
Timepoint
During the process of treatment
Method of measurement
Observation
5
Description
Fear of Dentistry
Timepoint
Before treatment and after the final session
Method of measurement
questionnaire
6
Description
Recovery time
Timepoint
After treatment completion
Method of measurement
Observation
7
Description
Respiratory Rate
Timepoint
At the beggining of the study and then every 15 minutes
Method of measurement
Monitoring
8
Description
Blood Pressure
Timepoint
At the beggining of the study and then every 15 minutes
Method of measurement
Monitoring
9
Description
Oxygen Saturation
Timepoint
At the beggining of the study and then every 15 minutes
Method of measurement
Monitoring
Secondary outcomes
1
Description
Adverse reactions
Timepoint
During and after treatment
Method of measurement
Observation
Intervention groups
1
Description
InterventionGroup B (Midazolam-Hydroxyzine): in this group, Hydroxyzine is administered with a dose of 1mg/kg at first, after 30 minutes Midazolam (0.5 mg/kg in mixture with the same volume of 10% sugar syrup) will be administered to the patient by cup and under the supervision of anesthesiologist. In the case of uncooperation, the drug will be poured in the lower buccal vestibule by a syringe.Treatment will begin after 30 minutes.
Category
Treatment - Drugs
2
Description
Intervention group C (Oral Meperidine-Hydroxyzine): in this group both meperidine (2mg/kg) and hydroxyzine (1mg/kg) are administered simultaneousnessly 1 hour before treatment
Category
Treatment - Drugs
3
Description
Control Group (submucosal injection of meperidine-Hydroxyzine): in this group, Hydroxyzine (1mg/kg) is administered one hour before treatment. After 30 minutes of hydroxyzine administration, meperidine (1mg/kg) will be injected slowly in upper vestible between canine and first molar (11) at the opposite site of dental. The main treatment will be begun in half an hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Dental School
Full name of responsible person
Dr Toomarian
Street address
Daneshjoo Blvd, Evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Research Center, Shahid Beheshti Dental School
Full name of responsible person
DR Lida Toomarian
Street address
Evin, Daneshjoo Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Research Center, Shahid Beheshti Dental School
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 Dental school
Full name of responsible person
Ms Asgari
Position
Secretory of Investigation and Research Department
Other areas of specialty/work
Street address
Department of Research in Dental Sciences, Dental School, Daneshjoo blvd, Evin
City
Tehran
Postal code
19432
Phone
+98 21 2240 3010
Fax
Email
Iceberg2008@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Katayoun Salem
Position
Assistant Professor
Other areas of specialty/work
Street address
Dental School, Imam Blvd
City
Rasht
Postal code
19871
Phone
+98 13 1322 0060
Fax
Email
k_salem@gums.ac.ir , katayoun.salem@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Katayoun Salem
Position
Assistant Professor
Other areas of specialty/work
Street address
Dental school, Imam Blvd.
City
Rasht
Postal code
14871
Phone
+98 13 1323 0776
Fax
Email
k_salem@gums.ac.ir , katayoun.salem@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)