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Premedication by Clonidine Intranasal in Pediatric Surgery

NCT03725930 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-23

No results posted yet for this study

Summary

There are few studies using intra nasal way to dispense premedication in pediatrics.

This study will evaluate anxiolysis effect of Intranasal premedication with Clonidine vs Placebo.

Two groups, randomized,

Total of 150 patients (75 in each group) :

Involvement in study for one patient : 7 days Duration of study including inclusion and data analysis : 18 months (inclusion 12 months; data analysis 6 months)

Conditions

  • Child Preschool

Interventions

DRUG

Clonidine

clonidine intranasal premedication in preschool infants

OTHER

Placebo

Placebo intranasal premedication

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Dina BERT, MD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2021-11-24
Completion
2023-11-24

Countries

  • France

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 NCT03725930 on ClinicalTrials.gov