Procedural Pain Relief Clinical Trial
Official title:
Lidocaine/Tetracaine Patch (Ralydan) vs Lidocaine/Prilocaine Cream (EMLA) for Needle Related Procedures in Children: a Multicenter, Randomized Controlled Trial
| Verified date | March 2016 |
| Source | IRCCS Burlo Garofolo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 339 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Years to 10 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Italy | Ospedale Pediatrico Pausilipon - Servizio di terapia del dolore e cure palliative | Napoli | Campania |
| Italy | Università degli studi di Padova - Centro Regionale Veneto di terapia del dolore e cure palliative pediatriche | Padova | Veneto |
| Italy | IRCCS Burlo Garofolo | Trieste | Friuli Venezia Giulia |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS Burlo Garofolo |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Success at the first attempt | Percentage of success at first attempt | Intraoperative | No |
| Secondary | Pain score | The pain during the procedure will be evaluate using pain rating scale appropriate for age | Intraoperative | No |
| Secondary | Adverse events | The number and the type of adverse events will be recorded | Up to 15 minutes after the procedure | Yes |