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Evaluation of the sedative effect and safety of midazolam oral solution before general anesthesia for tonsillectomy and adenoidectomy in children

Evaluation of the sedative effect and safety of midazolam oral solution before general anesthesia for tonsillectomy and adenoidectomy in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111904
Enrollment
Unknown
Registered
2025-11-07
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Chronic tonsillitis

Interventions

Control group:30 minutes before general anesthesia, 0.5mg/kg of 5% glucose solution was orally administered in the pre-anesthesia room.
Experimental Group:30 minutes before general anesthesia, 0.5 mg/kg of midazolam oral solution was taken orally in the pre-anesthesia room.

Sponsors

Mianyang 404 Hospital (The First People's Hospital Of Mianyang)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 3 to 10 years old who are scheduled to undergo tonsillectomy and adenoidectomy under general anesthesia. 2. American Society of Anesthesiology (ASA) grade I-II. 3. BMI 15 to 18 kg/m^2. 4. Children who can cooperate and correctly understand Chinese and express their intentions. 5. The guardians of the children agree to the experimental protocol and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. The guardian of the patient did not consent to the experimental study. 2. The ASA classification is greater than grade II. 3. Children with abnormal mental state. 4. Children with diseases of the circulatory system, respiratory system, and nervous system. 5. Children who have used sedative drugs previously or before the operation. 6. Children who are allergic to the drugs used in this study, such as midazolam oral solution and glucose solution. 7. Children with acute angle-closure glaucoma or open-angle glaucoma that has not been effectively treated.

Design outcomes

Primary

MeasureTime frame
The Ramsay sedation score of the patient 30 minutes after taking the medication;

Secondary

MeasureTime frame
The m-YPAS score of the child when separated from his parents before anesthesia;The ICC score of the patient during the anesthesia induction period;The score for the child's acceptance of the medication during administration;The PAED score of the patient;

Countries

China

Contacts

Public ContactWang Jiao

Mianyang 404 Hospital (The First People's Hospital of Mianyang)

972628456@qq.com+86 158 0848 0267

Outcome results

None listed

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