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

IRCCS Burlo Garofolo

Status and phase: Completed; Phase 3

Conditions: Procedural Pain Relief

Treatments: Drug: Lidocaine/Tetracaine patch; Drug: Lidocaine/Prilocaine cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02519660

RC 6/13

Details and patient eligibility

About

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.

Enrollment: 339 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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339 participants in 2 patient groups

Lidocaine/Tetracaine patch (Ralydan)

Experimental group

Description:

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

Treatment:

Drug: Lidocaine/Tetracaine patch

Lidocaine/Prilocaine cream (EMLA)

Active Comparator group

Description:

EMLA cream is an eutectic mixture of local anaesthetic (lidocaine, prilocaine). It is applied in the site of venipuncture 60 minutes before needle procedure

Treatment:

Drug: Lidocaine/Prilocaine cream