A comparative evaluation of sedative effect of intravenous ketamine/midazolam with ketamine/dexmedetomidine combination in 2-6 years old uncooperative pediatric dental patient
Comparing the sedation effects of intravenous ketamine-midazolam and intravenous ketamine-dexmedetomidine combination in the dental treatment of non-cooperative children aged 2 to 6 years.
Design
Cross-over, double-blind, randomized clinical trial on 24 patients
Settings and conduct
This double-blind study will be conducted on 24 non-cooperative children referred to the pediatric dental fellowship department of the dental school who need at least two similar dental treatments. The patients will be randomly divided into two treatment groups, AB and BA. In group AB, drug regimen A (intravenous ketamine-midazolam) will be used in the first treatment session, and drug regimen B (intravenous ketamine-dexmedetomidine) will be used in the second session for sedation. In the BA group, the order of prescribing sedatives will be the opposite. All behavioral and physiological parameters of the patient will be recorded by the trained assistant during the different stages of the treatment.
Participants/Inclusion and exclusion criteria
Entry criteria:
non-cooperative children aged 2-6 years (completely negative based on Frankel scale classification)
The patient should be in ASA I group
The patient needs to perform at least 2 sessions of similar dental work and needs injections.
Exit criteria:
Do not have a systemic disease.
Do not be in ASA1, ASA2 groups.
Do not have contraindications to receive sedatives.
During sedation, they should not have symptoms of cold or respiratory tract obstruction.
Intervention groups
In order to control the pharmacological behavior of non-cooperative children during dental treatments, two medicinal groups of intravenous ketamine-midazolam and intravenous ketamine-dexmedetomidine will be used in comparison.
Main outcome variables
Success of dental treatment according to the Houpt criterion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230629058616N1
Registration date:2023-07-25, 1402/05/03
Registration timing:prospective
Last update:2023-07-25, 1402/05/03
Update count:0
Registration date
2023-07-25, 1402/05/03
Registrant information
Name
Masoud Seyedahadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4422 1555
Email address
drmasoud@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative evaluation of sedative effect of intravenous ketamine/midazolam with ketamine/dexmedetomidine combination in 2-6 years old uncooperative pediatric dental patient
Public title
Evaluation of sedative effect of ketamine/midazolam with ketamine/dexmedetomidine in dental uncooperative children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-cooperative children aged 2-6 years (completely negative based on the Frankel scale rating)
The patient should be in ASA I group.
The patient needs to perform at least 2 sessions of similar dental work and needs injection.
Exclusion criteria:
Do not have a systemic disease.
Do not be in ASA1, ASA2 groups.
.Do not have contraindications to receive sedatives.
During sedation, they should not have symptoms of cold or respiratory tract obstruction
Age
From 2 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Children selected to perform this clinical trial are randomly divided into two equal groups, in the first group (A) in one treatment session with the combination of intravenous ketamine/dexmedetomidine and in the next session with the combination of intravenous ketamine/midazolam under sedation. and in the second group (B) the order of prescribing the medicinal combination will be reversed.
Two dental treatment sessions should be designed in such a way that they are similar and comparable in terms of the type and duration of treatment.
The combination of studied drugs is also prepared by the anesthesiologist and prescribed to the patient during the treatment and according to the protocol.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the therapist are not aware of sedative medication regimen during dental procedures. The anesthesiologist and the care team will only be aware about that
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
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
The level of child's cooperation
Timepoint
Before dental treatment, during dental treatment and after dental treatment
Method of measurement
Observation and based on Houpt Behavioral Scale
2
Description
Heart Rate
Timepoint
Before dental treatment, during dental treatment and after dental treatment
Method of measurement
Pulse oximeter device
3
Description
Atrial oxygen saturation or Spo2
Timepoint
Before dental treatment, during dental treatment and after dental treatment
Method of measurement
Pulse oximeter device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group AB, combination of Dexmedetomidine (dose: 1μgr/kg) and ketamine (dose: 2 mg/kg) will be injected in the intervention phase and the first session of dental treatment for sedation induction. Propofol injection will continue (dose: 150μgr/kg/H) for sedation maintenance
Category
Treatment - Drugs
2
Description
Control group: In group BA, combination of Ketamine (dose: 2mgr/kg) and Midazolam (dose: 0.2 mg/kg) will be injected in the intervention phase and the first session of dental treatment for sedation induction.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Seyed Masoud Seyed Ahadi
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Daneshgah Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1471735576
Phone
+98 21 2217 5350
Email
dentit@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Masoud Fallahi Nezhad
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Daneshgah Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
+98 21 2243 9780
Phone
+98 21 2243 9780
Email
masoudfallah36@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Assistant of Shahid Beheshti University of Medical Sciences