INTRANASAL CLONIDINE PREDICTION IN PEDIATRIC SURGERY: RANDOMIZED STUDY AGAINST PLACEBO

Phase 1

• Conditions: intra-nasal premedication instead of oral, intravenous or nopremedication.; MedDRA version: 20.0Level: PTClassification code 10042609Term: SurgerySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2017-003638-10-FR
• Lead Sponsor: CHRU LILLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-12
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- Age of 1 to 5 years,
- Weight from 10 to 25 kg
- Signature of informed consent
- ASA 1 or 2, (ANNEX 6)
- Scheduled minor surgery
- Affiliation to Social Security
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Failure to obtain consent,
- Participation in another clinical trial involving a drug,
- Known contraindications or hypersensitivity to clonidine, or to any of
the excipients,
- Upper airway infection within 3 weeks prior to inclusion,
- Intravenous Induction,
- History of cardiac arrhythmia, congenital heart disease,
- Mental retardation or psychoactive treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified