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

NCT02519660 | Completed Phase 3

• 1 other identifier: RC 6/13
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 3

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.

Conditions

Procedural Pain Relief

Keywords

Ralydan; EMLA cream; Procedural pain; Phlebotomy; Child

Outcome Measures

Primary Outcomes (1)

• Success at the first attempt

  Percentage of success at first attempt

  Intraoperative

Secondary Outcomes (2)

• Pain score

  Intraoperative

• Adverse events

  Up to 15 minutes after the procedure

Study Arms (2)

Lidocaine/Tetracaine patch (Ralydan)

EXPERIMENTAL

Ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and tetracaine) through the skin. It is applied in the site of venipuncture 30 minutes before needle procedure

Drug: Lidocaine/Tetracaine patch

Lidocaine/Prilocaine cream (EMLA)

ACTIVE COMPARATOR

EMLA cream is an eutectic mixture of local anaesthetic (lidocaine, prilocaine). It is applied in the site of venipuncture 60 minutes before needle procedure

Drug: Lidocaine/Prilocaine cream

Interventions

Lidocaine/Tetracaine patch DRUG

Also known as: Ralydan

Lidocaine/Tetracaine patch (Ralydan)

Lidocaine/Prilocaine cream DRUG

Also known as: EMLA

Lidocaine/Prilocaine cream (EMLA)

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3 to 10 years
• Need for peripheral IV line or venipuncture
• Informed consent signed by parents or legal guardians

You may not qualify if:

• Need for emergency care
• Known allergy or sensitivity to local anesthetics

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (3)

Ospedale Pediatrico Pausilipon - Servizio di terapia del dolore e cure palliative

Napoli, Campania, 80121, Italy

Location

IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

Università degli studi di Padova - Centro Regionale Veneto di terapia del dolore e cure palliative pediatriche

Padua, Veneto, 35100, Italy

Location

MeSH Terms

Conditions

Pain, Procedural

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Egidio Barbi, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY CHAIR

• Elena Neri, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY DIRECTOR

• Giorgio Cozzi, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 11, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 28, 2016

Record last verified: 2016-03

Locations

IT (3)