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

NCT ID: NCT02519660

Last Updated: 2016-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-12-31

Brief Summary

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.

Conditions

Procedural Pain Relief

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Lidocaine/Tetracaine patch

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Lidocaine/Prilocaine cream

Intervention Type: DRUG

Interventions

Lidocaine/Tetracaine patch

Intervention Type: DRUG

Lidocaine/Prilocaine cream

Intervention Type: DRUG

Other Intervention Names

Ralydan; EMLA

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Ronfani Luca

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Egidio Barbi, MD

Role: STUDY_CHAIR

IRCCS Burlo Garofolo, Trieste, Italy

Elena Neri, MD

Role: STUDY_DIRECTOR

IRCCS Burlo Garofolo, Trieste, Italy

Giorgio Cozzi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Burlo Garofolo, Trieste, Italy

Locations

Ospedale Pediatrico Pausilipon - Servizio di terapia del dolore e cure palliative

Napoli, Campania, Italy

IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, Italy

Università degli studi di Padova - Centro Regionale Veneto di terapia del dolore e cure palliative pediatriche

Padua, Veneto, Italy

Countries

Italy

Other Identifiers

RC 6/13

Identifier Type: -

Identifier Source: org_study_id