Premedication by Clonidine Intranasal in Pediatric Surgery

University Hospital, Lille90 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Child Preschool

Interventions

ClonidineDRUG

clonidine intranasal premedication in preschool infants

PlaceboOTHER

Placebo intranasal premedication

Eligibility

Sex: ALLMin age: 1 YearMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CHRU Lille

Lille, Nord, France

Outcomes

Primary Outcomes

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

Acceptation of mask at the induction of anesthesia

Yes / No

Time frame: 1 hour after premedication

Agitation score after the extubation

Agitation score : 0 : Patient

Time frame: 15 min after extubation

Data from ClinicalTrials.gov

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