Interventions
The participants were randomly assigned to two groups the dexmedetomidine- midazolam (DM) group received 2 µg/kg intranasal dexmedetomidine (maximum 100 mcg) combined with 0.5 mg/kg oral midazolam (maximum 20.0 mg). The midazolam (M) group received 0.5 mg/kg oral midazolam (maximum 20.0 mg) combined with intranasal normal saline. The dexmedetomidine used in this trial was free of preservatives, with a concentration of 0.1 mg/mL: (You Bi Tuo; Yangzi River Pharmaceutical, Jiangsu, CHN, China). Undiluted dexmedetomidine was drawn into a 1 mL tuberculin syringe and administered using a nebulizer (MAD300, Wolf Tory Medical, Salt Lake City, ST, United States). For oral midazolam, an intravenous formulation (5 mg/mL; Nhwa Pharma Corporation, Jiangsu, CHN, China) was mixed with fruit juice using a volumetric ratio of 1:2.Before dental sedation, an anesthesiologist assessed each participant’s general condition, confirmed whether they met the inclusion criteria, and administered the sedation in accordance with the participant’s weight and randomization status. The anesthesiologist initially sprayed either the appropriate dexmedetomidine dose (for DM group), or an equal volume of normal saline (for M group), into both nostrils of each participant at a uniform rate. To maximize intranasal drug absorption, participants were encouraged to maintain the supine position for 1–2 min. After 10 min the anesthesiologist administered oral midazolam fruit drink for participants in the M and DM groups at a predetermined dose.Ramsay scale score[RSS]
Evaluation scales