Premedication by Clonidine Intranasal in Pediatric Surgery

Phase 3

• Conditions: Child Preschool
• Interventions: Drug: Clonidine; Other: Placebo

• Registration Number: NCT03725930
• Lead Sponsor: University Hospital, Lille

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-10-31
• Study Start: 2019-03-26
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-19
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clonidine	Clonidine	This arm will receive intra nasal Clonidine as a premedication before surgery
Placebo	Placebo	This arm will receive intra nasal Placebo as a premedication before surgery

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHRU Lille; 🇫🇷 Lille, Nord, France