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Application of oral midazolam preoperative sedation in the treatment of oral diseases in special children under general anesthesia

Anesthesiology

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067158
Enrollment
Unknown
Registered
2022-12-28
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

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) Age range from 2 to 14 years old, with either gender; (2) ASA 1~2 grade; (3) BMI 18.5~23.9 kg/m2; (4) Oral disease treatment was selected under general anesthesia, and the operation time was less than 3 h; (5) Suffered from autism, cerebral palsy, ADHD or intellectual disability; (6) Oral diseases include caries and chronic periodontitis.

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;Mask acceptance score for children;Postoperative agitation score of the children;

Secondary

MeasureTime frame
Children's anxiety visual analog score from accompanied parents ;Separation anxiety scale scores of children separated from parents;Recovery time, PACU stay time and postoperative observation time of the patients;Ramsay sedation score of children;

Countries

CHINA

Contacts

Public ContactQIN ZHAOJUN
qin1172001@aliyun.com15871619516

Outcome results

None listed

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