Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children

NCT ID: NCT06417125

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-22
• Study Completion Date: 2025-10-21

Brief Summary

The goal of this clinical trial is to learn the effect of dexmedetomidine premedication in postoperative negative behavior changes in children compared to midazolam premedication. It will also learn about the effect of dexmedetomidine and midazolam in emergence delirium. The main questions are:

• Dose dexmedetomidine lower the incidence of postoperative negative behavior changes compared to midazolam?
• Dose dexmedetomidine lower the incidence of emergence delirium compared to midazolam? Researchers will compare dexmedetomidine to midazolam (a common pediatric premedication) to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium.

Participants will:

• Take intranasal dexmedetomidine or oral midazolam or placebo (a look-alike substance that contains no drug) premedication
• Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 3, 7, and 30

Detailed Description

Due to the fear of being separated from parents, fear of venipuncture, and facing unfamiliar operating room environment, children have different degrees of anxiety before surgery. Preoperative anxiety can lead to strong stress response and increase the incidence of emergence delirium. It can even cause psychological trauma and affect children's physical and mental health growth. The study showed that preoperative anxiety was positively correlated with the incidence of emergence delirium and postoperative negative behavior change, and emergence delirium was a risk factor for postoperative negative behavior in children.

Currently, midazolam is the most commonly used sedative drug to relieve preoperative anxiety in children. Midazolam has anterograde amnesia effect, reducing the occurrence of intraoperative awareness, and alleviating psychological trauma and memory of malignant stimulation in children. Dexmedetomidine is a highly selective α2 adrenergic agonist with anxiolytic, sedative, and analgesic properties. Our previous study found that preoperative administration of dexmedetomidine can reduce the incidence of emergence delirium in children compared with midazolam However, no clinical studies have directly compared the effects of dexmedetomidine and midazolam premedication on postoperative negative behavior change in children.

This prospective randomized controlled trial was conducted to compare the effects of dexmedetomidine and midazolam premedication on preoperative anxiety, the incidence of postoperative delirium, and postoperative negative behavior changes in children to provide a reference for optimizing clinical anesthesia medication regimens.

Conditions

Behavior Problem

Keywords

dexmedetomidine; midazolam; postoperative negative behavior change; emergence delirium; tonsillectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dexmedetomidine group

Participants were premedicated with intranasal dexmedetomidine 2 μg/kg and oral sweet solution 0.25 mL/kg.

Group Type: EXPERIMENTAL

Dexmedetomidine Hydrochloride

Intervention Type: DRUG

Patients were premedicated with intranasal dexmedetomidine 2 μg/kg in the holding area.

Glucose solution

Intervention Type: DRUG

Patients were premedicated with oral sweet solution 0.25 mL/kg in the holding area.

Midazolam group

Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral midazolam 0.5 mg/kg.

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

Patients were premedicated with oral midazolam 0.5 mg/kg in the holding area.

normal Saline

Intervention Type: DRUG

Patients were premedicated with normal saline 0.02 mL/kg in the holding area.

Placebo group

Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral sweet solution 0.25 mL/kg.

Group Type: PLACEBO_COMPARATOR

normal Saline

Intervention Type: DRUG

Patients were premedicated with normal saline 0.02 mL/kg in the holding area.

Glucose solution

Intervention Type: DRUG

Patients were premedicated with oral sweet solution 0.25 mL/kg in the holding area.

Interventions

Dexmedetomidine Hydrochloride

Patients were premedicated with intranasal dexmedetomidine 2 μg/kg in the holding area.

Intervention Type: DRUG

Midazolam

Patients were premedicated with oral midazolam 0.5 mg/kg in the holding area.

Intervention Type: DRUG

normal Saline

Patients were premedicated with normal saline 0.02 mL/kg in the holding area.

Intervention Type: DRUG

Glucose solution

Patients were premedicated with oral sweet solution 0.25 mL/kg in the holding area.

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine hydrochloride Injection; Midazolam oral solution

Eligibility Criteria

Inclusion Criteria

1. ASA physical status I or II;

2. Aged 2-5 years;

3. Scheduled for elective tonsillectomy and (or) adenoidectomy.

Exclusion Criteria

1. Parents refusing to allow their children to participate;

2. Intake of sedative or analgesic medication within 48 hours before surgery;

3. Developmental delay;

4. Psychosis;

5. Body mass index > 30 kg/m2;

6. Allergy to study drugs;

7. Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.;

8. Any other conditions that precluded study inclusion.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Maternity and Child Health Hospital

OTHER

Sponsor Role: collaborator

Fujian Children's Hospital

UNKNOWN

Sponsor Role: collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yao Yusheng

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaochun Zheng, MD

Role: STUDY_CHAIR

Fujian Provincial Hospital

Locations

Fujian Provincial Hospital

Fuzhou, Fujian, China

Countries

China

Other Identifiers

K2024-01-006

Identifier Type: -

Identifier Source: org_study_id