Needle Procedures Success Rate After Application of Ralydan vs EMLA in Children

Lidocaine/Tetracaine Patch (Ralydan) vs Lidocaine/Prilocaine Cream (EMLA) for Needle Related Procedures in Children: a Multicenter, Randomized Controlled Trial

Needle-related procedures are among the most common sources of pain and distress for children in the health care setting. More than 50% of children reported pain during these procedures. The necessity for pain management during these procedures is well established. Topical anesthesia has been shown to be effective in managing needle-related pain. Eutectic mixture of local anaesthetic (EMLA) cream is the topical anesthetic most used. The application of this mixture of lidocaine and prilocaine reduce pain during needle procedures in children. To be effective EMLA cream must be applied for at least 60 minutes before needle procedure. This is the major limitation for its use in emergency settings.

Ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and tetracaine) through the skin. There is evidence of pain relief after 30 minutes from its application. Only one randomized controlled trial compared the two topical anaesthetics in children during venipuncture and showed that Ralydan patch led to superior analgesia than EMLA cream, even if in this study the two anaesthetics were applied only for 35 minutes before needle procedure. No differences were found in success rate of the procedure and vein visibility. In adult patients, Ralydan and EMLA were equally effective in pain relief after 60 minutes from application.

To the best of the investigators' knowledge there is no published study that compared needle procedure success rate in children and pain relief effectiveness of lidocaine/tetracaine patch and lidocaine/prilocaine cream, at time of their maximum analgesic effect.

The aim of this study is to compare Ralydan patch and EMLA cream at time of their maximum analgesic effect (30 minutes vs 60 minutes), regard to needle procedure success rate at the first attempt and pain relief in children.

Study Overview

• Status: Completed
• Conditions: Procedural Pain Relief
• Intervention / Treatment: Drug: Lidocaine/Tetracaine patch; Drug: Lidocaine/Prilocaine cream

• Study Type: Interventional
• Enrollment (Actual): 339
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Campania
    • Napoli, Campania, Italy, 80121
      • Ospedale Pediatrico Pausilipon - Servizio di terapia del dolore e cure palliative
  • Friuli Venezia Giulia
    • Trieste, Friuli Venezia Giulia, Italy, 34137
      • IRCCS Burlo Garofolo
  • Veneto
    • Padova, Veneto, Italy, 35100
      • Università degli studi di Padova - Centro Regionale Veneto di terapia del dolore e cure palliative pediatriche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 3 to 10 years
• Need for peripheral IV line or venipuncture
• Informed consent signed by parents or legal guardians

Exclusion Criteria:

• Need for emergency care
• Known allergy or sensitivity to local anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lidocaine/Tetracaine patch (Ralydan); Ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and tetracaine) through the skin. It is applied in the site of venipuncture 30 minutes before needle procedure	Drug: Lidocaine/Tetracaine patch; Other Names: Ralydan
ACTIVE_COMPARATOR: Lidocaine/Prilocaine cream (EMLA); EMLA cream is an eutectic mixture of local anaesthetic (lidocaine, prilocaine). It is applied in the site of venipuncture 60 minutes before needle procedure	Drug: Lidocaine/Prilocaine cream; Other Names: EMLA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success at the first attempt	Percentage of success at first attempt	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	The number and the type of adverse events will be recorded	Up to 15 minutes after the procedure
Pain score	The pain during the procedure will be evaluate using pain rating scale appropriate for age	Intraoperative

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Elena Neri, MD, IRCCS Burlo Garofolo, Trieste, Italy

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: August 7, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (ESTIMATE): August 11, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): March 28, 2016
• Last Update Submitted That Met QC Criteria: March 25, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Child; Procedural pain; Phlebotomy; EMLA cream; Ralydan
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics, Combined; Lidocaine; Prilocaine; Lidocaine, Prilocaine Drug Combination; Tetracaine
• Other Study ID Numbers: RC 6/13