NCT02519660

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 339 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Lidocaine/Tetracaine patch
DRUG	Lidocaine/Prilocaine cream

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-08-11
• Last updated: 2016-03-28

Locations

3 sites across 1 country: Italy