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The application of oral midazolam for preoperative sedation in the treatment of dental diseases in children with autism undergoing general anesthesia

The application of oral midazolam for preoperative sedation in the treatment of dental diseases in children with autism undergoing general anesthesia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114128
Enrollment
Unknown
Registered
2025-12-08
Start date
2025-03-13
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative anxiety of children

Interventions

Placebo control group:The same volume of 5% glucose and sodium chloride injection was administered orally 30 min before surgery.

Sponsors

Affiliated Stomatology Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Aged 2-14 years, with either gender; 2. ASA I-II grade; 3. BMI 18.5~23.9 kg/m^2; 4. Oral disease treatment was selected under general anesthesia, and the operation time was less than 3 h; 5. Suffered from autism.

Exclusion criteria

Exclusion criteria: 1. Allergic to the study drug; 2. Refused to take the study drug; 3. Combined with severe cardiopulmonary, liver and kidney dysfunction; 4. Combined with gastrointestinal dysfunction affecting drug absorption; 5. Take cytochrome P450 3A4 inhibitors (e.g., Clarithromycin) or inducers (e.g., Phenobarbital).

Design outcomes

Primary

MeasureTime frame
the modified Yale preoperative anxiety scores of children;Children's anxiety visual analog score from accompanied parents ;Separation anxiety scale scores of children separated from parents;Ramsay sedation score of children;

Secondary

MeasureTime frame
Mask acceptance score for children;Postoperative pain level score;Postoperative agitation score of the children;Recovery time, PACU stay time and postoperative observation time of the patients;Parental satisfaction;

Countries

China

Contacts

Public ContactZhaojun Qin

Affiliated Stomatology Hospital of Guangzhou Medical University

qin1172001@aliyun.com+86 158 7161 9516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026