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The effects of midazolam oral solution on perioperative anxiety-related behaviors in children undergoing Tonsillectomy and Adenoidectomy

The effects of midazolam oral solution on perioperative anxiety-related behaviors in children undergoing Tonsillectomy and Adenoidectomy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083327
Enrollment
Unknown
Registered
2024-04-22
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Anxiety

Interventions

midazolam oral solution:Oral Midazolam Solution
10% glucose injection:Oral 10% glucose injection
Low dose midazolam oral solution:Oral 0.25mg/kg Midazolam Oral Solution
Medium dose Midazolam oral solution group:Oral 0.5mg/kg Midazolam Oral Solution
High dose Midazolam oral solution group:Oral 0.75mg/kg Midazolam Oral Solution

Sponsors

Dongguan Maternal and Child Health Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1.2-7 years old, regardless of gender 2.ASA Class I~II 3.Selective tonsillectomy and adenoidectomy with endoscopic radiofrequency ablation under general anesthesia

Exclusion criteria

Exclusion criteria: 1.Allergy to midazolam 2.Family history of previous allergy to inhalation anesthetics or malignant hyperthermia 3. History of heart and lung diseases or recent upper respiratory tract infection 4.Growth retardation, mental retardation, hearing impairment or mental illness 5.BMI =28 kg/m^2 6.Severe obstructive sleep apnea 7.Participation in other intervention studies or refusal of informed consent

Design outcomes

Primary

MeasureTime frame
Incidence of anxiety before anesthesia induction;

Secondary

MeasureTime frame
Incidence of anxiety in children separated from their families;Acceptance of mask;Restlessness during recovery from general anesthesia;Incidence rate of family anxiety when separated from children;Sedation degree;Satisfaction of medical staff and family members;

Countries

China

Contacts

Public ContactYongcheng Li

Dongguan Maternal and Child Health Hospital

596235592@qq.com+86 135 8093 2866

Outcome results

None listed

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