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Preoperative oral midazolam sedation for pediatric outpatients in dental surgery: a randomized controlled study

Preoperative oral midazolam sedation for pediatric outpatients in dental surgery: a randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066686
Enrollment
Unknown
Registered
2022-12-13
Start date
2022-12-19
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

Separation anxiety

Interventions

Midazolam:Premedication of oral midazolam 0.5mg/kg in 30 minutes before the opening of vein with maximum dose of 15mg,with the volume of 10ml
Controll:Oral use of 10ml of 5% glucose solution 30 minutes before opening the vein

Sponsors

Peking university school and hospital of stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 10 Years

Inclusion criteria

Inclusion criteria: a. Children who plan to undergo tooth extraction at the maxillofacial surgery clinic b. Age 4 to 10 years old c. The expected operation time is less than 60 minutes d. Parents or legal guardians agree that children will join the study

Exclusion criteria

Exclusion criteria: a. Does not meet the conditions for elective surgery (such as recent history of upper respiratory tract infection, decompensation of severe systemic diseases period or other circumstances that the attending physician deems necessary to postpone the operation) b. Parents or legal guardians refuse to collect perioperative data of children c. Children with severe dental fear or mental retardation who cannot complete treatment under conscious sedation d. There are contraindications to the use of clinical anesthetic drugs (previous allergic history or suspected allergic history) e. Children with acute angle closure glaucoma or untreated children with open angle glaucoma

Design outcomes

Primary

MeasureTime frame
Separation anxiety score when children leave their parents;

Secondary

MeasureTime frame
Acceptance score of oral drugs;Acceptance score of venipuncture;HOUPT compliance score of children's oral treatment;Intraoperative memory score of children;Intraoperative drug use;Incidence of postoperative restlessness;Postoperative pain;Satisfaction score of operators and anesthesiologists;Preoperative dental anxiety score;

Countries

China

Contacts

Public ContactYang Xudong

Peking university school and hospital of stomatology

kqyangxudong@163.com010-82195287

Outcome results

None listed

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