Randomization and blinding
ADVERSE EVENT
For random grouping, a computerized random number generator was used. When parents or guardians provided written informed consent for their children to participate in this study, the computer software randomly generated a code (pre-defined code group) and participants were divided into two groups using these codes. The randomization codes were kept in sealed envelopes in order and held by the anesthesiologist. On the day of treatment, the anesthesiologist and nurse opened the envelope and prepared the study drugs according to the allocated group.Only the anesthesiologist and nurse involved in sedative administration had information concerning the sedative administered to each participant. If any adverse event occurred, clinical intervention was immediately implemented. The participants, their parents/guardians, the pediatric dentist and nurse involved in dental treatment, observer, data collector, and statistical analyst were unaware of each participant’s group assignment.