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Unknown statusPhase 4

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

NCT05925283 · Second Affiliated Hospital of Wenzhou Medical University

Closed to entry
Status
Not accepting participants
Phase 4
Phase
126
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Children are prone to anxiety and even fear before surgery, and such adverse emotions may not only lead to poor induction of anesthesia, but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children. There are many ways to relieve pediatric anxiety, including preoperative medication, games, and cartoons. Preoperative medication is the most commonly used method to relieve pediatric anxiety.The most commonly used pediatric preoperative sedation drugs are midazolam and esketamine.However, oral midazolam may not produce a sedative effect in 20-40% of patients. A good preoperative anxiety-reducing effect was seen in only 60-80% of cases.Therefore, this trial investigates whether the intranasal combination of esketamine with oral midazolam can produce better results than each of the two drugs alone. This will provide a reference for the selection of safe, reliable and appropriate preoperative sedation methods for pediatric patients and provide evidence-based support for comfort care.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • The degree of cooperation during inhalation anesthesia induction

    Measured over During inhalation anesthesia induction

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

2 Years to 6 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
The Second Affiliated Hospital of Wenzhou Medical UniversityWenzhouZhejiangChina

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05925283 on ClinicalTrials.gov →

Last updated in the registry 2023-06-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits