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Validation study on extrapolation of adult data on intranasally administered dexmedetomidine to the pediatric population

Validation study on extrapolation of adult data on intranasally administered dexmedetomidine to the pediatric population

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081244
Enrollment
Unknown
Registered
2024-02-27
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Simple vascular / lymphatic vessel malformation

Interventions

Group 3-6 years:Including children aged 3-6 years old, the anesthesiologist and family members work together to adjust the child's position so that the child is in a supine position with his head tilt
Group 7-12 years:Including children aged 7-12 years old, the anesthesiologist and family members work together to adjust the child's position so that the child is in a supine position with his head ti
Group 13-18 years:Including children aged 13-18 years old, the anesthesiologist and family members work together to adjust the child's position so that the child is in a supine position with his head

Sponsors

Guangzhou Medical University Affiliated Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Children with simple vascular/lymphatic malformations classified according to the International Society for the Study of Vascular Malformations (Milwaukee, WI) standard classification and requiring interventional surgery under general anesthesia; 2.Age 3-18 years old; The American Society of Anesthesiologists (ASA) assessment level is level I-III;

Exclusion criteria

Exclusion criteria: 1. Premature infants or children with severe growth and development delay; 2. Have a history of allergy or hypersensitivity to dexmedetomidine; 3. Severe heart, liver, and kidney dysfunction; 4. Have used dexmedetomidine or any other sedative within one week; 5. Active respiratory symptoms, runny nose, vascular malformation and other symptoms in or near the nasal cavity that may affect nasal drug absorption; 6. Nose bleeding, history of sinus surgery and severe nasal septum deviation;

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters;

Secondary

MeasureTime frame
Time to wake up ;Incidence of adverse events;

Countries

China

Contacts

Public ContactBilian Li

Guangzhou Women and Children's Medical Center

13570226780@126.com+86 135 7022 6780

Outcome results

None listed

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