CompletedPhase 3

Premedication by Clonidine Intranasal in Pediatric Surgery

France90 participantsStarted 2019-03-26

Plain-language 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)

Who can participate

Age range1 Year – 5 Years

SexALL

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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

What they're measuring

Anxiolysis score

Timeframe: at 30 minutes after premedication

Trial details

NCT IDNCT03725930

SponsorUniversity Hospital, Lille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-24

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