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

NCT06417125 | Completed Phase 4 DMC

• 1 other identifier: K2024-01-006
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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

Conditions

Behavior Problem

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative negative behavior changes

  Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

  Day 7 postoperatively

Secondary Outcomes (11)

• Incidence of postoperative negative behavior changes

  Day 1 postoperatively

• Incidence of postoperative negative behavior changes

  Day 3 postoperatively

• Incidence of postoperative negative behavior changes

  Day 30 postoperatively

• Incidence of emergence delirium

  Within 30 min after extubation

• Preoperative anxiety

  Before the intervention in holding area

Study Arms (3)

Dexmedetomidine group

EXPERIMENTAL

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

Drug: Dexmedetomidine Hydrochloride; Drug: Glucose solution

Midazolam group

ACTIVE COMPARATOR

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

Drug: Midazolam; Drug: normal Saline

Placebo group

PLACEBO COMPARATOR

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

Drug: normal Saline; Drug: Glucose solution

Interventions

Glucose solution DRUG

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

Dexmedetomidine group; Placebo group

Dexmedetomidine Hydrochloride DRUG

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

Also known as: Dexmedetomidine hydrochloride Injection

Dexmedetomidine group

Midazolam DRUG

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

Also known as: Midazolam oral solution

Midazolam group

normal Saline DRUG

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

Midazolam group; Placebo group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status I or II;
• Aged 2-5 years;
• Scheduled for elective tonsillectomy and (or) adenoidectomy.

You may not qualify if:

• Parents refusing to allow their children to participate;
• Intake of sedative or analgesic medication within 48 hours before surgery;
• Developmental delay;
• Psychosis;
• Body mass index \> 30 kg/m2;
• Allergy to study drugs;
• 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.;

Sponsors & Collaborators

• Fujian Children's Hospital: collaborator
• Fujian Maternity and Child Health Hospital: collaborator
• Fujian Provincial Hospital: lead

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Mental Disorders; Emergence Delirium

Interventions

Dexmedetomidine; Midazolam; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Xiaochun Zheng, MD

  Fujian Provincial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 16, 2024
• Study Start: May 22, 2024
• Primary Completion: September 22, 2025
• Study Completion: October 21, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: We would like to share our individual deidentified participant data beginning three months following the publication of the main results.
• Access Criteria: All the individual participant data collected during the trial, the study protocol, the statistical analysis plan, and the clinical study report can be accessed with approval from the corresponding author.

Locations

CN (1)