Our purpose of this study is to compare the efficacy, safety and side effects of oral midazolam and intrabuccal ketamine in the sedation of children who required oral procedures, in order to provide a safe and appropriate way of doing this.
In this study, children with oral procedure referring to the emergency department are divided into two groups using randomized blocking method. oral midazolam at a dose of 0.5 mg/ kg or intrabuccal ketamine at a dose of 3 mg/ kg is used for children sedation. Ramsay sedation scale was used for assessment of sedation level. A score of four is considered as adequately sedated. If it does not reach this level after 20 minutes, one half of the dose of the initial drug is repeated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children between 6 months and 12 years of age require oral procedures, which parents have the consent to participate in this study.
Exclusion criteria: known contraindications to the use of study drugs and having lung and neuromuscular disease.
Intervention groups
The intervention group received a single dose of ketamine intrabuccal (3 mg/kg) and the control group receives a single dose of oral midazolam (5 mg/kg).
Main outcome variables
The main outcome of the study is the efficacy and safety of Intrabuccal Ketamine for sedation in patients requiring the oral procedure.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038549N7
Registration date:2018-09-22, 1397/06/31
Registration timing:registered_while_recruiting
Last update:2018-09-22, 1397/06/31
Update count:0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Farhad Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 8804
Email address
drfarhadheydari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-31, 1397/05/09
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of intrabuccal ketamine and oral midazolam for sedation in children with oral procedures
Public title
Efficacy of intrabuccal ketamine for sedation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Required oral procedures
Take informed consent
Exclusion criteria:
Sensitivity to benzodiazepines
Low blood pressure
Having a lung disease
Having Nervous-Muscular Disorders
Known contraindications to study drug
Age
From 6 months old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization with Table of random numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
The drugs are prepared and packaged by a pharmacist who is not aware of the study and are divided into two groups A and B.A package containing ketamine and the other containing Midazolam. Individuals randomly receive one package. Except for a nurse who prescribes the drug, no other person, such as a doctor, researchers, parents of children, data collectors, outcome assessors, and data analysts are all kept blinded to the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences