Premedication by Clonidine Intranasal in Pediatric Surgery

  • STATUS
    Recruiting
  • End date
    Dec 19, 2023
  • participants needed
    90
  • sponsor
    University Hospital, Lille
Updated on 19 March 2021

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)

Details
Condition preschool child
Treatment Placebo, clonidine
Clinical Study IdentifierNCT03725930
SponsorUniversity Hospital, Lille
Last Modified on19 March 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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