Addition of fentanyl to Ketamin-Midazolam-based intravenous sedation for 2-6 years old uncooperative dental patients
Design
Randomized cross over triple blind clinical trial
Settings and conduct
32 children referred to the pedodontics department of Shahid Beheshti University of Medical Sciences at the dental school between the ages of 2 and 6 years with the criteria mentioned for clinical trial will be selected. The medications are prepared by an anesthetist and administered by an anesthetic technician without notice of clinician and of the selected drug type. A randomized computerized list for allocation of patients is used in two groups of 1 or 2 drug regimens to eliminate the Carry over effect. Blood pressure cuff, pulsed oximeter, chest lid probes are used. Oxygen and Nitrous Oxide administered through a nasal cannula at a total rate of 3 liters per minute.
Participants/Inclusion and exclusion criteria
2 to 6 years old non-cooperative children (definitely negative at Frankl's scale) that at least two pediatric dentist have evaluated their lack of co-operation; patients do not have any systemic disease, contraindication in drug usage, mouth opening limitation, macroglossia and tonsilar hypertrophy . patients need at least 2 same treatment session with local anesthetics.patient do not have any respiratory infection and nasal obstruction in treatment session.
Intervention groups
Intervention group 1: In 1st session intravenous sedation with Ketamin, Midazolam. In 2nd session intravenous sedation with Fentanyl, Ketamin and Midazolam.
Intervention group 2: In 1st session intravenous sedation with Fentanyl, Ketamin, Midazolam. In 2nd session intravenous sedation with Ketamin and Midazolam.
Main outcome variables
O2 saturation; Heart rate; Respiratory rate; Blood pressure; Sleepiness, motion, cry and overall behavior according to Houpt sedation scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140106016106N5
Registration date:2018-08-05, 1397/05/14
Registration timing:retrospective
Last update:2018-08-05, 1397/05/14
Update count:0
Registration date
2018-08-05, 1397/05/14
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
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-24, 1396/12/05
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-04-25, 1397/02/05
Trial completion date
empty
Scientific title
Effect of Fentanyl addition to Ketamin, Midazolam mixture in intravenous sedation of 2 to 6 years old uncooperative children
Public title
"Sedation with Fentanyl & Ketamin in pediatric dentistry"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
2 to 6 year old non-cooperative children (definitely negative at Frankl's scale) that at least two pediatric dentist have evaluated their lack of co-operation
At least 2 same treatment sessions with local anesthetics are required
The patient is in the ASA I group.
Exclusion criteria:
Patients with systemic diseases
Any contraindication in drug use
Any contraindication in sedation
Age
From 2 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient randomly receives intravenously Midazolam and Ketamine in a session and in other session Fentanyl, Ketamine and Midazolam.
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient's parents are acquainted with the research method and informed consent is obtained.
Patient,clinician and person that records behavioral effects.
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
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
Province
Tehran
Postal code
1983663113
Approval date
2017-08-07, 1396/05/16
Ethics committee reference number
IR.SBMU.RIDS.REC.1396.469
Health conditions studied
1
Description of health condition studied
Intravenous sedation in dentistry
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
O2 Saturation of blood
Timepoint
Recording O2 saturation at the baseline, anesthesia injection, 15 and 30 minutes after the start of treatment and at discharge of the patient
Method of measurement
Alborz Saadat hospital monitoring device
2
Description
Heart rate
Timepoint
Recording Heart rate at the baseline, anesthesia injection, 15 and 30 minutes after the start of treatment and at discharge of the patient
Method of measurement
Alborz Saadat hospital monitoring device
3
Description
Blood pressure
Timepoint
Recording Blood pressure at the baseline, anesthesia injection, 15 and 30 minutes after the start of treatment and at discharge of the patient
Method of measurement
Alborz Saadat hospital monitoring device
4
Description
Respiratory rate
Timepoint
Recording respiratory rate at the baseline, anesthesia injection, 15 and 30 minutes after the start of treatment and at discharge of the patient
Method of measurement
Alborz Saadat hospital monitoring device
5
Description
Sleepiness scale
Timepoint
Anesthesia injection, 15 and 30 minutes after the start of treatment
Method of measurement
Houpt sedation scale
6
Description
Crying scale
Timepoint
Anesthesia injection, 15 and 30 minutes after the start of treatment
Method of measurement
Houpt sedation scale
7
Description
Motion scale
Timepoint
Anesthesia injection, 15 and 30 minutes after the start of treatment
Method of measurement
Houpt sedation scale
8
Description
Overall behavior
Timepoint
Anesthesia injection, 15 and 30 minutes after the start of treatment
Method of measurement
Houpt sedation scale
Secondary outcomes
1
Description
Parents' opinion about sedation session
Timepoint
24 hours after treatment
Method of measurement
Questionaire
2
Description
Clinician opinion about treatment session
Timepoint
At the end of treatment session
Method of measurement
Questionaire
Intervention groups
1
Description
Intervention group 1: In 1st session oral Midazolam suspension premedication (0.5 mg/kg) is administered half an hour before IV Ketamin (up to 2 mg/kg), 1 mg Midazolam and 0.1 mg Atropin injection. Then in 2nd session oral Midazolam suspension premedication (0.5 mg/kg) is administered half an hour before IV Fentanyl ( up to 1 mcg/kg), Midazolam 1 mg, Atropin 0.1 mg, Ketamin (up to 2 mg/kg) injection.
Category
Treatment - Drugs
2
Description
Intervention group 2: in 1st session oral Midazolam suspension premedication (0.5 mg/kg) is administered half an hour before IV Fentanyl ( up to 1 mcg/kg), Midazolam 1 mg, Atropin 0.1 mg and Ketamin (up to2mg/kg) injection. Then in 2nd session oral Midazolam suspension premedication (0.5 mg/kg) is administered half an hour before IV Ketamin (up to 2 mg/kg), 1 mg Midazolam and 0.1 mg Atropin injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ghassem Ansari
Street address
Dental School, Student's Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 9421
Fax
+98 21 2225 5537
Email
drgansari@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9787
Fax
+98 21 2243 9981
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
Ghassem Ansari
Position
PhD, Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Students Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2225 5958
Fax
+98 21 2225 5537
Email
drgansari@yahoo.com
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
PhD, Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Students Blvd, Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2225 5958
Fax
+98 21 2225 5537
Email
drgansari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical University
Full name of responsible person
Ghassem Ansari
Position
PhD, Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Dental School, Students Blvd, Evin
City
Tehran
Province
Tehran
Postal code
19863
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)
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Drug dose used and data results
When the data will become available and for how long
Accessibility 6 month after issuing results
To whom data/document is available
Researchers in medical or dental universities
Under which criteria data/document could be used
Statistical analysis and the use of data with the exact mention of the source is indispensable.
From where data/document is obtainable
Aii Rashidian, DDS, MS
Email: A_rashidian@dentaliau.ac.ir
Address: 1945883919, 8 unit, n 492, Pasdaran Ave., Tehran
What processes are involved for a request to access data/document