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Effects of oral midazolam and intranasal dexmedetomidine on preoperative sedation and postoperative rehabilitation in pediatric outpatients undergoing dental caries surgery

Effects of oral midazolam and intranasal dexmedetomidine on preoperative sedation and postoperative rehabilitation in pediatric outpatients undergoing dental caries surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079369
Enrollment
Unknown
Registered
2024-01-02
Start date
2024-01-03
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

pediatric anesthesia

Interventions

oral midazolam (Group M):The pediatric patients will be given 0.75mg/kg midazolam oral solution (the maximum dose was 15mg) and 0.3ml normal saline intranasal drops
intranasal dexmedetomidine(Group D):The pediatric patients will receive 5ml normal saline orally and 2ug/kg dexmedetomidine original injection intranasally drop (given with 1ml OT needle).
oral midazolam combied with intranasal dexmedetomidine (Group MD):The pediatric patients will be given 0.5mg/kg midazolam oral solution and 1ug/kg dexmedetomidine injection intranasal drops

Sponsors

Shanxi Provincial Children’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: (1) Pediatric patients undergoing ambulatory dental caries surgery under general anesthesia (2) either sex (3) Ages 2-7 years old (4) ASA I-II

Exclusion criteria

Exclusion criteria: (1)BMI25 (2) patients who have some factors that affect the communication between researchers and children, such as mental retardation, deaf-mutes and so on (3) patients who have systemic diseases such as the respiratory system, cardiovascular system, nervous system, endocrine system or digestive system etal. (4) children with poor surgical or anesthesia experience (5) children with an allergy history

Design outcomes

Primary

MeasureTime frame
the modified Observer's Assessment of Alertness/Sedation,m-OAA/S;Post Hospitalization Behavior Questionnaire for Ambulatory Surgery,PHBQ-AS);

Secondary

MeasureTime frame
parental separation anxiety scale,PSAS;Mask Acceptance Scale,MAS;postanesthesia emergence delirium,PAED;

Countries

China

Contacts

Public ContactWeizhi Zhang

Shanxi Provincial Children’s Hospital

47592894@qq.com+86 152 3415 5563

Outcome results

None listed

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