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CompletedNCT03725930CLONIPREMUpdated Dec 23, 2025

Premedication by Clonidine Intranasal in Pediatric Surgery

A Phase 3 interventional study of Clonidine and Placebo in Child Preschool, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 1 Year to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by University Hospital, Lille · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
1 Year to 5 Years
Sex
All
01

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)

02

Conditions studied

  • Child Preschool

Keywords

  • paediatric
  • premedication
  • clonidine
  • intranasal
03

In context

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Refusal of one of the parental authority or legal representing
  2. Concomitant participation to a clinical trial with use of a drug
  3. Known hypersensitivity or contraindication to Clonidine or one of its excipients
  4. Airway infection within 3 weeks before inclusion
  5. Intravenous induction of anesthesia
  6. Antecedent of arrhythmia or congenital heart disease
  7. Mental disorder or current psychoactive medication
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Clonidine

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

    Drug: Clonidine

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • DrugClonidine

    clonidine intranasal premedication in preschool infants

  • OtherPlacebo

    Placebo intranasal premedication

06

What researchers measure

Primary outcomes

  1. Anxiolysis score

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

    Time frame: at 30 minutes after premedication

Secondary outcomes

  1. Acceptation of mask at the induction of anesthesia

    Yes / No

    Time frame: 1 hour after premedication

  2. Agitation score after the extubation

    Agitation score : 0 : Patient

    Time frame: 15 min after extubation

07

Study locations

1 site
  • CHRU Lille
    Lille, Nord 59000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03725930
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Oct 31, 2018
Start date
Mar 26, 2019
Primary completion
Nov 24, 2021
Completion
Nov 24, 2023
Last update
Dec 23, 2025

Study contacts

Dina BERT, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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