Pediatric Dental Caries
Conditions
Interventions
Group A :Administer 0.25 mg/kg of midazolam oral solution before inhalational induction.
Group B :Administer 0.5 mg/kg of midazolam oral solution before inhalational induction.
Group C :Administer 0.75 mg/kg of midazolam oral solution before inhalational induction.
Sponsors
Third Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: (1) Children undergoing dental caries treatment under daytime general anesthesia; (2) Aged 2-6 years old; (3) ASA physical status classification ?-? (no severe cardiopulmonary disease or metabolic abnormality); (4) Body weight within the normal range for children of the same age (5th-95th percentile on the WHO growth curve); (5) Presence of preoperative anxiety (modified Yale Preoperative Anxiety Scale score >= 30); (6) Expected operation time of 30-120 minutes; (7) Guardians have signed the informed consent form and agreed to cooperate with postoperative follow-up.
Exclusion criteria
Exclusion criteria: (1) Obese children (BMI > 30); (2) Allergic to midazolam or excipients in its preparation. (3) Currently taking other medications. (4) Having active respiratory tract infections, at risk of difficult airway, or suffering from obstructive sleep apnea syndrome (OSA). (5) Special populations such as those with intellectual disability, cerebral hypoxia at birth, or autism. (6) Complicated with severe cardiopulmonary diseases, impaired liver and kidney function, or neurological disorders. (7) Acute angle-closure glaucoma or open-angle glaucoma that has not been effectively treated. (8) Congenital metabolic disorders, a history of or family history of malignant hyperthermia. (9) Having experienced severe behavioral abnormalities (such as delirium, aggressive behavior) after previous sedation/general anesthesia. (10) Guardians or children refuse to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the optimal dose of midazolam oral solution for reducing induction anxiety in children undergoing oral treatment under general anesthesia based on the assessment of cooperation during the induction period and the induction scores.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Yale Preoperative Anxiety Scale (mYPAS) score;The incidence of delirium during the emergence period from anesthesia;Length of stay in the recovery room;Time to meet the discharge criteria;Postoperative pain score ;Incidence of adverse events;Postoperative 1-day Behavioral Questionnaire (PHBQ) score; | — |
Countries
China
Contacts
Public ContactGao Zhenzhen
Third Affiliated Hospital of Air Force Medical University
Outcome results
None listed