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The Effects of Oral Midazolam Solution on Preoperative Anxiety and Postoperative Agitation in Pediatric Patients Undergoing Total Extraperitoneal Procedure (TEP)

The Effects of Oral Midazolam Solution on Preoperative Anxiety and Postoperative Agitation in Pediatric Patients Undergoing Total Extraperitoneal Procedure (TEP)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124292
Enrollment
Unknown
Registered
2026-05-09
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

pediatric inguinal hernia

Interventions

Intervention group:Oral midazolam 30 minutes before surgery (0.5 mg/kg, maximum dose 15 mg, mixed in 5 mL apple juice) Routine care
Control group:Orally take 5ml of apple juice 30 minutes before surgery, routine care

Sponsors

Meishan City Peoples Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1.Aged 2 to 7 years old, meeting the elective surgical indications for laparoscopic totally extraperitoneal inguinal hernia repair (TEP); 2.ASA grade ?-?,with good basic physical condition and no severe organic dysfunction; 3.The children's guardians voluntarily participate in the study, sign the informed consent form, and are able to cooperate with the completion of relevant preoperative and postoperative assessments as well as follow-up; 4.There are no contraindications to the modified Yale Preoperative Anxiety Scale (m-YPAS) and the Pediatric Anesthesia Emergence Delirium (PAED) scale; emotional state scoring can be performed routinely.

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity to midazolam, benzodiazepines, or excipients such as apple juice used in the study; 2.Presence of central nervous system diseases, mental retardation, autism, or other conditions that affect emotional assessment; 3.Presence of severe underlying diseases including respiratory insufficiency, abnormal hepatic and renal function, cardiovascular diseases, etc; 4.Administration of sedative-hypnotics, anxiolytics, or other medications that may affect emotional status within 48 hours preoperatively; 5.On the day of surgery, acute infectious symptoms such as fever (body temperature = 38.5°C), cough, vomiting, etc; 6.The children's guardians cannot cooperate with data collection or follow-up, or there are other circumstances that affect the implementation of the study;

Design outcomes

Primary

MeasureTime frame
Modified Yale Preoperative Anxiety Scale (m-YPAS) Score;

Secondary

MeasureTime frame
Pediatric Anesthesia Emergence Delirium (PAED) Scale Score;

Countries

China

Contacts

Public ContactZhong Zheng

Meishan City Peoples Hospital

841528584@qq.com+86 28 3823 5337

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026