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

NCT05925283 | Unknown Phase 4

• 1 other identifier: SAHoWMU-CR2023-03-105
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• The degree of cooperation during inhalation anesthesia induction

  Induction Compliance Checklist range from 0 through 10,and lower scores indicate the higher degree of cooperation during inhalation anesthesia induction

  During inhalation anesthesia induction

Secondary Outcomes (6)

• Anxiety before induction of anesthesia

  Each 10 minutes during the forty minutes of preoperative period

• The level of sedation

  Each 10 minutes during the forty minutes of preoperative period

• Parental separation anxiety scale

  During the preoperative period

• Recovery times

  Within up to 30 minutes after child's first eye opening in the postoperative period

• Pediatric anesthesia emergence delirium

  Within up to 15-30 minutes after child's first eye opening in the postoperative period

Study Arms (3)

midazolam

PLACEBO COMPARATOR

Patients were assigned to receive oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.

Drug: Midazolam

esketamine

EXPERIMENTAL

Patients were assigned to receive intranasal esketamine 1mg/kg approximately 30-40 minutes before surgery using a computer-generated random number table.

Drug: Esketamine

midazolam and esketamine

EXPERIMENTAL

Patients were assigned to receive intranasal esketamine 0.6mg/kg and oral midazolam 0.3mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.

Drug: midazolam and esketamine

Interventions

Midazolam DRUG

oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.

Also known as: oral midazolam

midazolam

Esketamine DRUG

intranasal esketamine 1mg/kg approximately 30-40 mins before surgery using a computer-generated random number table.

Also known as: Intranasal esketamine

esketamine

midazolam and esketamine DRUG

oral midazolam 0.3mg/kg and intranasal esketamine 0.6mg/kg approximately 30-40 mins before surgery using a computer-generated random number table.

Also known as: combination with intranasal esketamine and oral midazolam

midazolam and esketamine

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Midazolam; Esketamine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Huacheng Liu

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• Xulin Zhang

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huacheng Liu

CONTACT

18957755138; huachengliu@163.com

Xulin Zhang

CONTACT

18583748800; 867237394@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 29, 2023
• Study Start: June 30, 2023
• Primary Completion: November 30, 2023
• Study Completion: March 30, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)