NCT03725930

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 26, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2023

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

October 29, 2018

Last Update Submit

December 16, 2025

Conditions

Child Preschool

Keywords

paediatricpremedicationclonidineintranasal

Outcome Measures

Primary Outcomes (1)

  • Anxiolysis score

    Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative

    at 30 minutes after premedication

Secondary Outcomes (2)

  • Acceptation of mask at the induction of anesthesia

    1 hour after premedication

  • Agitation score after the extubation

    15 min after extubation

Study Arms (2)

Clonidine

ACTIVE COMPARATOR

This arm will receive intra nasal Clonidine as a premedication before surgery

Drug: Clonidine

Placebo

PLACEBO COMPARATOR

This arm will receive intra nasal Placebo as a premedication before surgery

Other: Placebo

Interventions

ClonidineDRUG

clonidine intranasal premedication in preschool infants

Clonidine
PlaceboOTHER

Placebo intranasal premedication

Placebo

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child from 1 to 5 years
  • Weight between 10 to 25 kgs
  • Scheduled minor surgery
  • Oral and written information and consent given by main investigator to both of the parents or legal(s) representative(s).
  • ASA score 1 or 2
  • Patient with social care insurance

You may not qualify if:

  • Refusal of one of the parental authority or legal representing
  • Concomitant participation to a clinical trial with use of a drug
  • Known hypersensitivity or contraindication to Clonidine or one of its excipients
  • Intravenous induction of anesthesia
  • Antecedent of arrhythmia or congenital heart disease
  • Mental disorder or current psychoactive medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Lille

Lille, Nord, 59000, France

Location

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dina BERT, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2018

First Posted

October 31, 2018

Study Start

March 26, 2019

Primary Completion

November 24, 2021

Study Completion

November 24, 2023

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

FR(1)