MedTrace Logo

Intranasal Remimazolam for Premedication in Pediatric Patient

NCT04720963 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-09-08

No results posted yet for this study

Summary

Anesthetic inhalation induction could be one of the most stressful experiences for children during the perioperative period, with almost 50% of them showing anxiety. It is an essential challenge for pediatric anesthesiologists on how to decrease anxiety for children in the operating room (OR) environment and to facilitate a smooth induction of anesthesia. Various factors like parental separation, unfamiliar surroundings, fear of physicians and needle injections can increase their preoperative anxiety. The researchers conducted the current study to investigate whether intranasal remimazolam can reduce anxiety in children before surgery.

Conditions

  • Sedative; Anxiety Disorder

Interventions

DRUG

Remimazolam

intranasal remimazolam

OTHER

Distilled water for injection

intranasal distilled water for injection

DRUG

Dexmedetomidine

Intranasal dexmedetomidine

Sponsors & Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Huacheng Liu · Second Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-07
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • China

Study Locations

More Related Trials

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 NCT04720963 on ClinicalTrials.gov