Premedication by Clonidine Intranasal in Pediatric Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03725930

Acronym

CLONIPREM

Enrollment

Registered

2018-10-31

Start date

2019-03-26

Completion date

2023-11-24

Last updated

2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Preschool

Keywords

paediatric, premedication, clonidine, intranasal

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)

Interventions

DRUGClonidine

clonidine intranasal premedication in preschool infants

OTHERPlacebo

Placebo intranasal premedication

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 5 Years

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Acceptation of mask at the induction of anesthesia	1 hour after premedication	Yes / No
Agitation score after the extubation	15 min after extubation	Agitation score : 0 : Patient

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026