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

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ClinicalTrials.gov Identifier: NCT02519660
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : March 28, 2016
Sponsor:
Information provided by (Responsible Party):
Ronfani Luca, IRCCS Burlo Garofolo

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.


Condition or disease Intervention/treatment Phase
Procedural Pain Relief Drug: Lidocaine/Tetracaine patch Drug: Lidocaine/Prilocaine cream Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Lidocaine/Tetracaine Patch (Ralydan) vs Lidocaine/Prilocaine Cream (EMLA) for Needle Related Procedures in Children: a Multicenter, Randomized Controlled Trial
Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Lidocaine/Tetracaine patch (Ralydan)
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
Other Name: Ralydan

Active Comparator: Lidocaine/Prilocaine cream (EMLA)
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
Other Name: EMLA




Primary Outcome Measures :
  1. Success at the first attempt [ Time Frame: Intraoperative ]
    Percentage of success at first attempt


Secondary Outcome Measures :
  1. Pain score [ Time Frame: Intraoperative ]
    The pain during the procedure will be evaluate using pain rating scale appropriate for age

  2. Adverse events [ Time Frame: Up to 15 minutes after the procedure ]
    The number and the type of adverse events will be recorded



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519660


Locations
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Italy
Ospedale Pediatrico Pausilipon - Servizio di terapia del dolore e cure palliative
Napoli, Campania, Italy, 80121
IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Università degli studi di Padova - Centro Regionale Veneto di terapia del dolore e cure palliative pediatriche
Padova, Veneto, Italy, 35100
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
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Study Chair: Egidio Barbi, MD IRCCS Burlo Garofolo, Trieste, Italy
Study Director: Elena Neri, MD IRCCS Burlo Garofolo, Trieste, Italy
Principal Investigator: Giorgio Cozzi, MD IRCCS Burlo Garofolo, Trieste, Italy
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Responsible Party: Ronfani Luca, MD, PhD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT02519660    
Other Study ID Numbers: RC 6/13
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016
Keywords provided by Ronfani Luca, IRCCS Burlo Garofolo:
Ralydan
EMLA cream
Procedural pain
Phlebotomy
Child
Additional relevant MeSH terms:
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Pain, Procedural
Pain
Neurologic Manifestations
Lidocaine
Tetracaine
Prilocaine
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined