Evaluation of the sedative effect of different sedation methods in children's dental treatment

A double-blinded randomized controlled trial of oral midazolam vs intranasal dexmedetomidine plus oral midazolam for outpatient pediatric sedation

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100042300

Enrollment

Unknown

Registered

2021-01-17

Start date

2021-01-20

Completion date

Unknown

Last updated

2021-06-14

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

Conditions

Dental anxiety

Interventions

Group M:oral midazolam

group DM:combination of intranasal dexmedetomidine (2µg/kg) and oral midazolam (0.5mg/kg, maximum 20.0 mg)

Eligibility

Sex/Gender

All

Age

3 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children with dental anxiety were enrolled in the trial only if they were under twelve years old within the normal range of weight, with ASA physical status I or II and more than two teeth needed dental treatment.

Exclusion criteria

Exclusion criteria: Exclusion criteria includes a known medical history of neurological or cognitive alterations, allergy to study drugs, arrhythmia, heart disease or organ dysfunction, any treatment with sedatives; suffered from a respiratory infection or obstructive disease in the past week; and those who refused to participate or withdraw from the research.

Design outcomes

Primary

Measure	Time frame
Frankl scale;Ramsay sedation score;Houpt scale;	—

Secondary

Measure	Time frame
adverse events;	—

Countries

China

Contacts

Public ContactNie Juan

Shenzhen Children's Hospital

13518289033@163.com+86 13518289033

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026