Premedication by Clonidine Intranasal in Pediatric Surgery (CLONIPREM)

University Hospital, Lille

Status and phase: Enrolling; Phase 3

Conditions: Child Preschool

Treatments: Drug: Clonidine; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03725930

2016_37

2017-003638-10 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment: 90 estimated patients

Sex: All

Ages: 1 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Clonidine

Active Comparator group

Description:

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

Treatment:

Drug: Clonidine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo