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Comparison of sedative and analgesic effects of the different concentrations of alfentanil in children dental procedure

Comparison of sedative and analgesic effects of the different concentrations of alfentanil in children dental procedure

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043320
Enrollment
Unknown
Registered
2021-02-10
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Pediatric oral disease, general anesthesia, emergence agitation

Interventions

Group A:saline
Group B:The initial dose of alfentanil was 4 µ g / kg, the additional maintenance dose was 4 µ g / kg, and the additional dose was 4 µ g / kg 10 minutes before the end of the operation
GroupC:Infusion of alfentanil at a rate of 0.2µg/kg/min intravenously during the surgery
GroupD:Infusion of alfentanil at a rate of 0.4µg/kg/min intravenously during the surgery

Sponsors

Stomatological Hospital Affiliated to Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 2-7 years old, ASA grade I-II; 2. The subjects who planned to receive oral treatment under general anesthesia and the estimated operation time was 90min ~ 150min; 3. The family member or guardian shall be fully informed and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects with difficult intubation; 2. Oxygen dependent subjects; 3. Subjects with congenital heart disease; 4. Subjects with congenital lung disease; 5. Subjects with upper respiratory tract obstruction; 6. Subjects with high risk of aspiration; 7. Obese subjects (BMI > 30); 8. Subjects with drug allergy; 9. The family members are not able to use the mobile phone app to answer the questionnaire.

Design outcomes

Primary

MeasureTime frame
Emergence Agitation;recovery time;

Secondary

MeasureTime frame
pain scor;complications;

Countries

China

Contacts

Public ContactZhao Nan

Stomatological Hospital Affiliated to Chongqing Medical University

500586@hospital.cqmu.edu.cn+86 18523129117

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026