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

NCT02519660 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2016-03-28

No results posted yet for this study

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

DRUG

Lidocaine/Tetracaine patch

DRUG

Lidocaine/Prilocaine cream

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Egidio Barbi, MD · IRCCS Burlo Garofolo, Trieste, Italy

  • Elena Neri, MD · IRCCS Burlo Garofolo, Trieste, Italy

  • Giorgio Cozzi, MD · IRCCS Burlo Garofolo, Trieste, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02519660 on ClinicalTrials.gov