FindTrial
Sign In

Ralydan vs EMLA in venous punture and incannulation procedure

Comparative evaluation of the effectiveness of EMLA vs. Ralydan in the procedures for venipuncture and venous cannulation. Randomized controlled trial.. - Ralydan vs EMLA

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-001751-23-IT
Enrollment
320
Registered
2014-08-26
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedures for venipuncture and venous incannulation in pediatric patients MedDRA version: 17.0 Level: PT Classification code 10059445 Term: Venipuncture System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Ralydan 70 Mg/70 Mg Product Name: Ralydan 70 Mg/70 Mg Pharmaceutical Form: Transdermal patch Trade Name: EMLA 2,5% + 2,5% Product Name: EMLA 2,5% + 2,5% Pharmaceutical Form: Cream

Sponsors

IRCCS Burlo Garofolo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Compare the efficacy of EMLA vs. Ralydan in procedures for venipuncture or venous incannulation when the two devices have achieved the effect of anesthetic (EMLA for 60 min and 30 min for Ralydan).;Secondary Objective: Number of attempts needed to perform the procedure of venipuncture and incannulation;Primary end point(s): Success of the procedure at first attempt in relation to the anesthetic used (EMLA vs. Ralydan);Timepoint(s) of evaluation of this end point: 30 or 60 minutes—

Secondary

MeasureTime frame
Secondary end point(s): 1. The effectiveness of the two local anesthetics in reducing pain, assessed by administering VAS scale or Wong-Backer scale, depending on the age of the patient. 2. Effectiveness of the two local anesthetics in reducing pain according to evaluation by the medical staff with the VAS scale. 3. Number of attempts needed to carry out the procedure;Timepoint(s) of evaluation of this end point: 30 or 60 minutes—

Countries

Italy

Contacts

Public ContactAlessandra Maestro

IRCCS Burlo Garofolo

alessandra.maestro@burlo.trieste.it00390403785417

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026