CLONIPREM: Premedication by Clonidine Intranasal in Pediatric Surgery

• Sponsor: University Hospital, Lille (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03725930
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 56.2
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Child Preschool	Drug: Clonidine; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Premedication by Clonidine Intranasal in Pediatric Surgery
• Actual Study Start Date: Mar 26, 2019
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Anxiolysis score [at 30 minutes after premedication]

   Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative

Secondary Outcome Measures

1. Acceptation of mask at the induction of anesthesia [1 hour after premedication]

   Yes / No

2. Agitation score after the extubation [15 min after extubation]

   Agitation score : 0 : Patient

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU Lille	Lille	Nord	France	59000

Sponsors and Collaborators

• University Hospital, Lille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT03725930
• Other Study ID Numbers: 2016_37; 2017-003638-10
• First Posted: Oct 31, 2018
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Lille: paediatric; premedication; clonidine; intranasal
• Additional relevant MeSH terms: Clonidine

Study Results

No Results Posted as of Aug 19, 2022