Procedural Pain ReliefPhase 3NCT02519660
Needle Procedures Success Rate After Application of Ralydan vs EMLA in Children
A Phase 3 study testing Lidocaine/Tetracaine patch and Lidocaine/Prilocaine cream in people with Procedural Pain Relief, run by IRCCS Burlo Garofolo at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Procedural Pain Relief
- What is being tested?
- Lidocaine/Tetracaine patch and Lidocaine/Prilocaine cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 3 sitesItaly
- Study dates
- Apr 2015to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3 to 10 years
- Need for peripheral IV line or venipuncture
- Informed consent signed by parents or legal guardians
Who cannot join
- Need for emergency care
- Known allergy or sensitivity to local anesthetics
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale Pediatrico Pausilipon - Servizio di terapia del dolore e cure palliative
Naples, Campania, 80121
Università degli studi di Padova - Centro Regionale Veneto di terapia del dolore e cure palliative pediatriche
Padova, Veneto, 35100
IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, 34137
About this study
Official title: Lidocaine/Tetracaine Patch (Ralydan) vs Lidocaine/Prilocaine Cream (EMLA) for Needle Related Procedures in Children: a Multicenter, Randomized Controlled Trial
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.
Read more
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
- Being tested
- Lidocaine/Tetracaine patch, Lidocaine/Prilocaine cream
- Keywords
- Ralydan, EMLA cream, Procedural pain, Phlebotomy, Child
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine/Tetracaine patchDrug
Also called Ralydan
Lidocaine/Prilocaine creamDrug
Also called EMLA
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Lidocaine/Prilocaine cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success at the first attempt
Percentage of success at first attempt
Measured: Intraoperative
Secondary outcomes (2)
Pain score
The pain during the procedure will be evaluate using pain rating scale appropriate for age
Measured: Intraoperative
Adverse events
The number and the type of adverse events will be recorded
Measured: Up to 15 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural Pain ReliefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronfani Luca, IRCCS Burlo Garofolo
- Investigators
- Egidio Barbi, MD, Study chair, IRCCS Burlo Garofolo, Trieste, ItalyElena Neri, MD, Study director, IRCCS Burlo Garofolo, Trieste, ItalyGiorgio Cozzi, MD, Principal investigator, IRCCS Burlo Garofolo, Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519660
- Sponsor's protocol ID
- RC 6/13
- Status last verified
- Mar 2016
- First submitted
- 7 Aug 2015
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine/Tetracaine Patch (Ralydan) vs Lidocaine/Prilocaine Cream (EMLA) for Needle Related Procedures in Children: a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02519660
- Acronym / sponsor ID
- RC 6/13
- Conditions
- Procedural Pain Relief
- Keywords
- Ralydan, EMLA cream, Procedural pain, Phlebotomy, Child
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine/Tetracaine patch (Ralydan) | Experimental | Drug: Lidocaine/Tetracaine patchRalydan 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 |
| Lidocaine/Prilocaine cream (EMLA) | Active comparator | Drug: Lidocaine/Prilocaine creamEMLA cream is an eutectic mixture of local anaesthetic (lidocaine, prilocaine). It is applied in the site of venipuncture 60 minutes before needle procedure |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 3 to 10 years
- Need for peripheral IV line or venipuncture
- Informed consent signed by parents or legal guardians
Key exclusion criteria (2 listed)
- Need for emergency care
- Known allergy or sensitivity to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine/Tetracaine patchAlso: Ralydan | Drug | Lidocaine/Tetracaine patch (Ralydan) |
| Lidocaine/Prilocaine creamAlso: EMLA | Drug | Lidocaine/Prilocaine cream (EMLA) |
Primary outcome
Success at the first attempt
Time frame: Intraoperative
Percentage of success at first attempt
2 secondary outcomes
Pain score
Time frame: Intraoperative
Adverse events
Time frame: Up to 15 minutes after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egidio Barbi, MD study chair
IRCCS Burlo Garofolo, Trieste, Italy
Elena Neri, MD study director
IRCCS Burlo Garofolo, Trieste, Italy
Giorgio Cozzi, MD principal investigator
IRCCS Burlo Garofolo, Trieste, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine/Tetracaine patch and Lidocaine/Prilocaine cream in people with Procedural Pain Relief, run by IRCCS Burlo Garofolo at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success at the first attempt (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.