The study aimed to evaluate the safety and effectiveness of pharmaceutical composition Ketamine, Midazolam and Atropine and compare the sedative effect of oral administration of this compound with intramuscular in the referent uncooperative children who need a dental treatment at emergency department. A crossover clinical trial was conducted on 31 uncooperative children aged 1-4, who required dentistry with local anesthesia and were definitely negative based on the Frankel scale. Cases (First group) were randomly given ketamine (10 mg/kg) and midazolam (0.2 mg/kg) and atropine (0.02 mg/kg) orally in a visit. While they (The second group) were given Ketamine (6 mg/kg), Midazolam (0.05 mg/kg) and Atropine (0.02 mg/kg) through the intramuscular route in second visit. Both the researchers and patients are unaware of the research process. A computer programming is used to randomly select patients of two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030926983N1
Registration date:2016-05-28, 1395/03/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-28, 1395/03/08
Registrant information
Name
Nilgoon Pasdar
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11321995926
Email address
nilgoonpasdar@gmail.com
Recruitment status
Recruitment complete
Funding source
ُVice chancellor for research of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral administration versus intramuscular Ketamine, Midazolam, Atropine combination on sedation in pediatric dentistry
Public title
Comparison of oral administration versus intramuscular Ketamine, Midazolam, Atropine combination on sedation in pediatric dentistry
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Uncooperative children were confirmed by two pediatric dentists ranked as definitely negative the Frankel scale who referred for dental treatment under local anesthesia, requiring at least two dental visits for two similar dental treatments.
Exclusion criteria: Having systemic disease, medical contradictions
Age
From 1 year old to 4 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
31
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
Arabi. St. Yaman. St. Chamran Highway, Tehran
City
Tehran
Postal code
Approval date
2011-07-06, 1390/04/15
Ethics committee reference number
9017
Health conditions studied
1
Description of health condition studied
Dental
ICD-10 code
K02.8
ICD-10 code description
Other dental caries
Primary outcomes
1
Description
Ocular response
Timepoint
Every one hour
Method of measurement
Eyes closed or nystagmus present, eyes open or no nystagmus
2
Description
Response to voice
Timepoint
Every one hour
Method of measurement
None-incoherent
3
Description
Response to touch
Timepoint
Every one hour
Method of measurement
Not arousable, sleepy, awake
4
Description
Sedation
Timepoint
Every one hour
Method of measurement
Ocular response, response to voice and touch
Secondary outcomes
empty
Intervention groups
1
Description
Children in control group receive cocktail of 10 mg/kg Ketamine, 0.2 mg/kg Midazolam and 0.02 mg/kg Atropine orally.
Category
Treatment - Drugs
2
Description
In intervention group, each child receive an injection cocktail of 6 mg/kg Ketamine, 0.05 mg/kg Midazolam and 0.02 mg/kg Atropine through the gluteal region at their first dental session.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Pediatric Hospital
Full name of responsible person
Dr Ghasem Ansari
Street address
Shariati Ave, District 3, Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
The Department of Pediatric Dentistry of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ghasem Ansari
Street address
Shariati Ave, District 3, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ghasem Ansari
Street address
Arabi. St. Yaman. St. Chamran Highway, Tehran
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 for 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
Babol University of Medical Sciences
Full name of responsible person
Neda Amani
Position
Surgical Tecnologist
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganj Afrouz St. Babol, Iran
City
Babol
Postal code
Phone
+98 11 3219 9592
Fax
Email
neda_amani69@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nilgoon Pasdar
Position
Dentist
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganj Afrouz St. Babol, Iran
City
Babol
Postal code
Phone
+98 11 3219 9592
Fax
Email
nilgoonpasdar@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)