Premedication by Clonidine Intranasal in Pediatric Surgery
Overview
- Phase
- Phase 3
- Intervention
- Clonidine
- Conditions
- Child Preschool
- Sponsor
- University Hospital, Lille
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Anxiolysis score
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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)
Investigators
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
Arms & Interventions
Clonidine
This arm will receive intra nasal Clonidine as a premedication before surgery
Intervention: Clonidine
Placebo
This arm will receive intra nasal Placebo as a premedication before surgery
Intervention: Placebo
Outcomes
Primary Outcomes
Anxiolysis score
Time Frame: at 30 minutes after premedication
Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative
Secondary Outcomes
- Agitation score after the extubation(15 min after extubation)
- Acceptation of mask at the induction of anesthesia(1 hour after premedication)