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Evaluation of efficacy and safety of different sedative methods in oral therapy of autistic children

Evaluation of efficacy and safety of different sedative methods in oral therapy of autistic children

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049458
Enrollment
Unknown
Registered
2021-08-02
Start date
2021-07-30
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Autism

Interventions

Experimental group1:The subjects were sedated by intramuscular injection of 0.20mg/kg midazolam
Experimental group2:The subjects were sedated by intramuscular injection of 0.24mg/kg midazolam
Experimental group3:The subjects were sedated by intramuscular injection of midazolam 0.20mg/kg combined with nasal spray of dexmedetomidine 2.0ug/kg

Sponsors

Shenzhen Children’s hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Autistic children aged 3 to 12 years(ASA grade I or II); 2. The preoperative Frankl treatment compliance scale score is 1 point, and the behavioral induction is invalid; 3. The risk of airway obstruction is small (tonsillar hypertrophy occupies less than 50% of the oropharynx); 4. The oral diseases are: deciduous tooth caries, pulpitis or periapical periodontitis (the total operation time is less than 60min).

Exclusion criteria

Exclusion criteria: 1. Allergic to the study drug; 2. Suffering from systemic diseases and organ dysfunction; 3. Suffering from respiratory infection or obstructive disease in the past week; 4. Refused to participate in the study, quit midway or lost contact during follow-up.

Design outcomes

Primary

MeasureTime frame
Ramsay sedation Scale score;Frankl treatment compliance evaluation Scale score;Houpt whole-process compliance rating scale;

Secondary

MeasureTime frame
heart rate;

Countries

China

Contacts

Public ContactYang Ge

Shenzhen Children’s hospital

Yanggelucky@163.com+86 18824252606

Outcome results

None listed

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