Ralydan vs EMLA in venous punture and incannulation procedure

Phase 1

• Conditions: Procedures for venipuncture and venous incannulation in pediatric patients; MedDRA version: 17.0Level: PTClassification code 10059445Term: VenipunctureSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-001751-23-IT
• Lead Sponsor: IRCCS Burlo Garofolo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-26
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

- Children aged 3 to 10 years
- The need to perform venipuncture or venous incannulation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 320
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

- Subjects who need urgent care
- Subjects with known hypersensitivity to local anesthetics
- Subjects enrolled in other studies for venipuncture / cannulation

Study & Design

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