Premedication by Clonidine Intranasal in Pediatric Surgery (CLONIPREM)

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 Overview

• Status: Recruiting
• Conditions: Child Preschool
• Intervention / Treatment: Drug: Clonidine; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dina BERT, MD; Phone Number: +33 3 20 44 60 69; Email: dina.bert@chru-lille.fr

Study Locations

• France
  • Nord
    • Lille, Nord, France, 59000
      • Recruiting
      • CHRU Lille
      • Contact: Dina Bert, Dr.; Phone Number: +3320446269; Email: dina.bert@chru-lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Clonidine; This arm will receive intra nasal Clonidine as a premedication before surgery	Drug: Clonidine; clonidine intranasal premedication in preschool infants
Placebo Comparator: Placebo; This arm will receive intra nasal Placebo as a premedication before surgery	Other: Placebo; Placebo intranasal premedication

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Dina BERT, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: intranasal; premedication; clonidine; paediatric
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympatholytics; Clonidine
• Other Study ID Numbers: 2016_37; 2017-003638-10 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No