Clinical trial NCT02519660: Needle Procedures Success Rate After Application of Ralydan vs EMLA in Children
Official title: Lidocaine/Tetracaine Patch (Ralydan) vs Lidocaine/Prilocaine Cream (EMLA) for Needle Related Procedures in Children: a Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Procedural Pain Relief
Keywords: Ralydan
EMLA cream
Procedural pain
Phlebotomy
Child
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 339
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Success at the first attempt
timeFrame: Intraoperative
Secondary outcomes:
measure: Pain score
timeFrame: Intraoperative
measure: Adverse events
timeFrame: Up to 15 minutes after the procedure
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Ospedale Pediatrico Pausilipon - Servizio di terapia del dolore e cure palliative
state: Campania
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
city: Padova
country: Italy
facility: Università degli studi di Padova - Centro Regionale Veneto di terapia del dolore e cure palliative pediatriche
state: Veneto
Study officials:
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Egidio Barbi, MD
role: STUDY_CHAIR
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Elena Neri, MD
role: STUDY_DIRECTOR
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Giorgio Cozzi, MD
role: PRINCIPAL_INVESTIGATOR
References: