Premedication by Clonidine Intranasal in Pediatric Surgery | NCT03725930

Studies
Premedication by Clonidine Intranasal in Pediatric Surgery

NCT03725930

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Dec 23, 2025Actual

Enrollment

90Actual

Phase

Phase 3

Conditions

Child Preschool

Interventions

Clonidine
Placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-003638-10	EudraCT Number

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2019Actual

Primary Completion Date

Nov 24, 2021Actual

Completion Date

Nov 24, 2023Actual

First Submitted Date

Oct 29, 2018

First Submission Date that Met QC Criteria

Oct 30, 2018

First Posted Date

Oct 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Clonidine	Drug	clonidine intranasal premedication in preschool infants	Clonidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anxiolysis score	Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative	at 30 minutes after premedication

Secondary Outcomes

Measure	Description	Time Frame
Acceptation of mask at the induction of anesthesia	Yes / No	1 hour after premedication
Agitation score after the extubation	Agitation score : 0 : Patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Airway infection within 3 weeks before inclusion
Intravenous induction of anesthesia
Antecedent of arrhythmia or congenital heart disease
Mental disorder or current psychoactive medication

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dina BERT, MD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Lille		Lille	Nord	59000	France

Intervention Browse Module

MeSH Terms

ID	Term
D003000	Clonidine

Ancestor Terms

ID	Term
D048288	Imidazolines
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

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Browse Branches

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