Premedication by Clonidine Intranasal in Pediatric Surgery (CLONIPREM)

U

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

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

Trial contacts and locations

0

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Central trial contact

Dina BERT, MD

Data sourced from clinicaltrials.gov

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