Premedication by Clonidine Intranasal in Pediatric Surgery

Child Preschool Clinical Trial

— CLONIPREM  

Official title:

Premedication by Clonidine Intranasal in Pediatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03725930
• Other study ID #: 2016_37
• Secondary ID: 2017-003638-10
• Status: Recruiting
• Phase: Phase 3
• Start date: March 26, 2019
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: University Hospital, Lille
• Contact: Dina BERT, MD
• Phone: 3 20 44 60 69
• Email: dina.bert[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Preschool

Intervention

Drug:
• Clonidine
clonidine intranasal premedication in preschool infants

Other:
• Placebo
Placebo intranasal premedication

Locations

Country	Name	City	State
France	CHRU Lille	Lille	Nord

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiolysis score	Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative	at 30 minutes after premedication
Secondary	Acceptation of mask at the induction of anesthesia	Yes / No	1 hour after premedication
Secondary	Agitation score after the extubation	Agitation score : 0 : Patient	15 min after extubation