Premedication by Clonidine Intranasal in Pediatric Surgery

Overview

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)

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2023

Interventions

  • Drug: Clonidine
    • clonidine intranasal premedication in preschool infants
  • Other: Placebo
    • Placebo intranasal premedication

Arms, Groups and Cohorts

  • Active Comparator: Clonidine
    • This arm will receive intra nasal Clonidine as a premedication before surgery
  • Placebo Comparator: Placebo
    • This arm will receive intra nasal Placebo as a premedication before surgery

Clinical Trial Outcome Measures

Primary Measures

  • Anxiolysis score
    • Time Frame: at 30 minutes after premedication
    • Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative

Secondary Measures

  • Acceptation of mask at the induction of anesthesia
    • Time Frame: 1 hour after premedication
    • Yes / No
  • Agitation score after the extubation
    • Time Frame: 15 min after extubation
    • Agitation score : 0 : Patient

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dina BERT, MD, Principal Investigator, University Hospital, Lille
  • Overall Contact(s)
    • Dina BERT, MD, 3 20 44 60 69, dina.bert@chru-lille.fr

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