Using oral midazolam and intranasal esketamine to reduce anxiety in children before surgery

Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation

This study is testing if giving kids aged 2-6 a mix of oral midazolam and intranasal esketamine can help reduce their anxiety before surgery better than using just one of these medications alone.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 2 Years to 6 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University (Academic / other)
• Locations: 1 site (Wenzhou, Zhejiang)
• Trial ID: NCT05925283 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining oral midazolam with intranasal esketamine to alleviate preoperative anxiety in children aged 2-6 years. The study aims to determine if this combination provides better sedation outcomes compared to using each medication alone. Participants will be assessed using various scales to measure anxiety levels, sedation scores, and recovery times. The trial will involve children scheduled for lower abdominal and perineal surgeries with a short expected operation time.

Who should consider this trial

Good fit: Ideal candidates are children aged 2-6 years with ASA physical status I or II, scheduled for short lower abdominal or perineal surgeries.

Not a fit: Patients with gastrointestinal, cardiovascular, or endocrine dysfunction, or those with contraindications to the medications will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve preoperative sedation and reduce anxiety-related complications in pediatric patients.

How similar studies have performed: While the combination of these medications is being explored, the specific approach of using both oral midazolam and intranasal esketamine together is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. with American Society of Anesthesiologists (ASA) physical status I or II；
2. aged 2-6 years；
3. children with weight for age within the normal range
4. were scheduled lower abdominal and perineal surgery with an expected operation time shorter than 30 minutes.

Exclusion Criteria:

1. Children who had gastrointestinal,Cardiovascular or endocrine dysfunction;
2. contraindication to preoperative sedation or had a known allergy or hypersensitive reaction to either esketamine or midazolam;
3. with any nasal pathology,organ dysfunction;
4. recently respiratory infection, mental disorder;
5. other reasons that researchers hold it is not appropriate to participate in this trial.

Where this trial is running

Wenzhou, Zhejiang

• The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Huacheng Liu — Second Affiliated Hospital of Wenzhou Medical University
• Study coordinator: Huacheng Liu

Conditions Anxiety