Needle Procedures Success Rate After Application of Ralydan vs EMLA in Children
Information source: IRCCS Burlo Garofolo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Procedural Pain Relief
Intervention: Lidocaine/Tetracaine patch (Drug); Lidocaine/Prilocaine cream (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: IRCCS Burlo Garofolo Official(s) and/or principal investigator(s): Egidio Barbi, MD, Study Chair, Affiliation: IRCCS Burlo Garofolo, Trieste, Italy Elena Neri, MD, Study Director, Affiliation: IRCCS Burlo Garofolo, Trieste, Italy Giorgio Cozzi, MD, Principal Investigator, Affiliation: IRCCS Burlo Garofolo, Trieste, Italy
Overall contact: Giorgio Cozzi, MD, Phone: +390403785338, Email: giorgiocozzi@gmail.com
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.
Clinical Details
Official title: Lidocaine/Tetracaine Patch (Ralydan) vs Lidocaine/Prilocaine Cream (EMLA) for Needle Related Procedures in Children: a Multicenter, Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Success at the first attempt
Secondary outcome: Pain scoreAdverse events
Eligibility
Minimum age: 3 Years.
Maximum age: 10 Years.
Gender(s): Both.
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
Locations and Contacts
Giorgio Cozzi, MD, Phone: +390403785338, Email: giorgiocozzi@gmail.com
Ospedale Pediatrico Pausilipon - Servizio di terapia del dolore e cure palliative, Napoli, Campania 80121, Italy; Recruiting Fabio Borrometi, MD, Email: fabioborrometi@fastwebnet.it
IRCCS Burlo Garofolo, Trieste, Friuli Venezia Giulia 34137, Italy; Recruiting Giorgio Cozzi, MD, Phone: 390403785338, Email: giorgiocozzi@gmail.com
Università degli studi di Padova - Centro Regionale Veneto di terapia del dolore e cure palliative pediatriche, Padova, Veneto 35100, Italy; Recruiting Franca Benini, MD, Email: benini@pediatria.unipd.it
Additional Information
Starting date: April 2015
Last updated: August 10, 2015
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