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

NCT06417125 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2025-12-22

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine Hydrochloride

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

DRUG

Midazolam

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

DRUG

normal Saline

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

DRUG

Glucose solution

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

Sponsors & Collaborators

  • Fujian Maternity and Child Health Hospital

    collaborator OTHER

  • Fujian Children's Hospital

    collaborator UNKNOWN

  • Fujian Provincial Hospital

    lead OTHER

Principal Investigators

  • Xiaochun Zheng, MD · Fujian Provincial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-22
Primary Completion
2025-09-22
Completion
2025-10-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06417125 on ClinicalTrials.gov