Premedication by Clonidine Intranasal in Pediatric Surgery
NCT ID: NCT03725930
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2019-03-26
2023-11-24
Brief Summary
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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)
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Clonidine
This arm will receive intra nasal Clonidine as a premedication before surgery
Clonidine
clonidine intranasal premedication in preschool infants
Placebo
This arm will receive intra nasal Placebo as a premedication before surgery
Placebo
Placebo intranasal premedication
Interventions
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Clonidine
clonidine intranasal premedication in preschool infants
Placebo
Placebo intranasal premedication
Eligibility Criteria
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Inclusion Criteria
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
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
1 Year
5 Years
ALL
Yes
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Dina BERT, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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CHRU Lille
Lille, Nord, France
Countries
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Other Identifiers
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2017-003638-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2016_37
Identifier Type: -
Identifier Source: org_study_id