Sedative level of IV administration of Fentanyl/Ketamine cocktail with IV administration of Fentanyl/Midazolam cocktail in uncooperative pediatric patients
Design
Randomized controlled double blind clinical trial, Phase 3 on 30 patients
Group I: get FAM in 1st visit and FAK in 2nd,
Group II: get FAK in 1st visit and FAM in
Sample sized is adopted from earlier similar studies.
Settings and conduct
Informed consent was obtained from parents while ethics approval was sought from the Ethics committee of the university. Children of 2 to 6 years were selected from those referred to the Dental School Shahid Beheshti University of Medical Sciences. Cases are schedules for treatment at Hospital Dentistry fellowship Clinic of this school. Patients are randomly divided into two groups, Group I: will receive FAK at 1st sedation session and FAM at 2nd while Group II: receives FAM at 1st and FAK at 2nd sedation session.
Operator and evaluators are blind to the injective drug contents.
Participants/Inclusion and exclusion criteria
inclusion criteria: uncooperative pediatric patients of 2 to 6 years of age (definitely negative in Frankl scale) confirmed by two pedodontists needing two treatment sessions with administration of local anesthesia. Only patients in ASA are included.
exclusion criteria: patients with systemic disease, common cold, any contraindication of drug use or sedation, Allergy.
Intervention groups
Intervention group: FAM is administered at a session
Control group: FAK is administered at other session
Main outcome variables
determination of the effect of FAK in sedating these children
determination of effect of FAM in sedating these children
determining the potential changes in BP, RR, SPO2, PR in each session.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140106016106N7
Registration date:2020-11-30, 1399/09/10
Registration timing:retrospective
Last update:2020-11-30, 1399/09/10
Update count:0
Registration date
2020-11-30, 1399/09/10
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
Expected recruitment start date
2019-04-08, 1398/01/19
Expected recruitment end date
2020-12-17, 1399/09/27
Actual recruitment start date
2019-04-08, 1398/01/19
Actual recruitment end date
2020-03-31, 1399/01/12
Trial completion date
2020-05-03, 1399/02/14
Scientific title
Comparison of sedative effect of intravenous Ketamin/Fentanyl with Midazolam/Fentanyl on 2-6 years old uncooperative pediatric dental patients
Public title
Evaluation of sedative effect of ketamine/fentanyl and midazolam/fentanyl on dental uncooperative children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 2 to 6 years
Patients needing at least 2 similar dental treatment sessions
،treating each tooth requires local Anesthesia.
pediatric patients in ASA I
Uncooperative child definitely negative (in Frankl scale)
Exclusion criteria:
Patients with any Systemic disease
Patients having common cold at treating session
any contraindication for the use of drugs
any contraindication for the use of sedation
Drug Allergy
Age
From 2 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Child aged 2-6 years with two similar dental treatment needs in one jaw. Both sexes will be accepted for inclusion.
Actual sample size reached:
25
More than 1 sample in each individual
Actual sample size in each individual:
2
Carious primary molars with pulpal involvement in both sides of a jaw are selected with similar size cavities needing similar treatments and consuming relatively close times.
Randomization (investigator's opinion)
Randomized
Randomization description
In order to Assess the sequence effect on patient's behavior, all participats will randomly be assigned into one of the two groups, with group I receiving experimental drug combination (Fentanyl Atropin Midazolam) at the first visit and Control drug combination (Ketamine Atropine Fentanyl ) at the second visit while the second group will receive the Control drug combination (Ketamine Atropine Fentanyl ) at the first visit and experimental drug combination (Fentanyl Atropin Midazolam) at the second visit in opposite order.
A table of randomization of numbers will be used for allocation of samples for the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Preparation of experimental and control drugs into previously coded syringes are performed by the anesthesiologist in charge. In this line the operator (researcher) and the two judging evaluators do not have any clue of the content of the syringes.
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
Street address
Dental Research Institute, Dental School , Shahid Beheshti University of Medical Sciences, Students Blvd ,Evin ,Chamran High Way
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.SBMU.DRC.REC.1398.220
Health conditions studied
1
Description of health condition studied
Uncooperative Pediatric Dental patient
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Induced sufficient sedation for delivering dental treatment
Timepoint
baseline, at IV sedation, every 15 min afterwards, at discharge
Method of measurement
Recording data in prepared forms in addition to a questionnaire
Secondary outcomes
1
Description
Adverse effects of the sedative drugs used
Timepoint
at discharge and 24 hours later
Method of measurement
Questionnaire and by phone
Intervention groups
1
Description
Intervention group: Receiving the drug combination of Fentanyl1-2 µg/kg micrograms , Midazolam 0.2 mg/kg , Atropine 0.1 mg/kg IV in one of the two randomize assigned and scheduled visits using an IV line while all vital signs are checked and recorded at start and in every 15 minute intervals.
Category
Treatment - Drugs
2
Description
Control group: Receiving the drug combination of Fentanyle1 to 2 µg/kg , Midazolam 0.2 mg/kg , Atropine 0.1 mg/kg in one of the two randomly assigned scheduled visits by randomization table using an IV line while all vital signs are checked and recorded at start and in every 15 minute intervals during treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatric Dentistry, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ghassem Ansari
Street address
Dental School, Shahid Beheshti University of Medical Sciences, Students Blvd, Evin,
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 9421
Fax
+98 21 2240 3897
Email
drgansari@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
3rd Floor, Next to Taleghani Hospital, Evin, Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9780
Fax
+98 21 2243 9781
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ghassem Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Department of Pediatric Dentistry, Dental School, Shahid Beheshti University of Medical Sciences, Students Blvd, Evin,
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 9421
Email
drgansari@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ghassem Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Dept of Pediatric Dentistry, Dental School, Shahid Beheshti University of Medical Sciences, Students Blvd, Evin, Chamran High Way
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 9421
Email
drgansari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Sara Shafiee
Position
Fellowship resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 20, #1 Kamraniyeh Bldg, West Lavasani cross, Kamraniyeh Cross
City
Tehran
Province
Tehran
Postal code
1998653141
Phone
+98 21 2265 1556
Email
shafieeinsta@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Raw Data for Fentanyl Ketamine Project
When the data will become available and for how long
A year and half after publication
To whom data/document is available
Future Fellowship Residents
Under which criteria data/document could be used
Taking a view as well as cotrolling the accuracy
From where data/document is obtainable
Dr Ghassem Ansari
What processes are involved for a request to access data/document
Presenting a request to the Vice chancelor for research at Shahid Beheshti University of Medical Sciences