-
Study aim
-
Oral premedication of midazolam, ketamine and dexmedetomidine in sedation and facilitation of separation of children from parents will be compared.
-
Design
-
Clinical trial with 3 parallel groups of intervention, double-blind, randomized by block method, phase 3 on 153 patients
-
Settings and conduct
-
In this double-blind randomized clinical trial study, eligible patients in Arak University of Medical Sciences affiliated hospitals, after obtaining informed consent, enter the study and are randomly divided into 3 groups by block method. The drug (midazolam or ketamine or dexmedetomidine) is given by the intern, who is unaware of the type of drug being prescribed, into syringe under the child's tongue to be swallowed with a short pause in the mouth. Sedation score, ease of separation and acceptance of anesthesia drug as well as blood pressure, heart rate, arterial oxygen saturation, time to get Aldrete score 8 and above as well as side effects (nausea and vomiting, hypotension, bradycardia) are recorded and studied.
-
Participants/Inclusion and exclusion criteria
-
Age 2 to 7 years
Weight between 10 and 30 kg
ASA I or II
Candidate for elective surgery except for fractures
Absence of any fracture operation
No history of allergies
Absence of liver, kidney and cardiopulmonary disorders
Lack of long-term use of anticonvulsant drugs, sleep disorders
Absence of speech or communication problems
Absence of gastrointestinal disorders (due to oral administration of drugs)
The duration of surgery is less than 120 minutes
Consent of parents and guardians of the child
-
Intervention groups
-
Eligible children are randomly divided into 3 intervention groups that will receive orally before the surgery, the first group: midazolam, the second group: ketamine and the third group: dexmedetomidine.
-
Main outcome variables
-
sedation score; Ease of separation score; Acceptance of drug Score - Each based on the relevant table