Vascular AccessNCT04695054
Buzzy Plus EMLA Cream for Vascular Access in Children
A study testing Buzzy device plus EMLA cream and Only EMLA cream in people with Vascular Access, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Venepuncture and peripheral intravenous cannulation are commonly performed in children and may cause substantial pain and distress. The aim of this study is to evaluate the efficacy of the combination of EMLA cream and Buzzy device in pain and distress relief during venipuncture or peripheral vascular access in… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Vascular Access
- What is being tested?
- Buzzy device plus EMLA cream and Only EMLA cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2023to 1 Dec 2023
- Phase
- Interventional
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children between 4 and 12yrs of age needing venipuncture or peripheral vascular access
- children who have applied EMLA cream at least 60 minutes before the procedure
Who cannot join
- children with cognitive impairment
- children with skin lesion that does not allow the application of Buzzy device
- children diseases that cause hypersensibility to cold (i.e. Raynaud syndrome, sickle cell disease)
- children who have taken any analgesics in the 8 hours before enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Use of Buzzy and EMLA Cream for Vascular Access in Children. A Randomized Controlled Trial
Venepuncture and peripheral intravenous cannulation are commonly performed in children and may cause substantial pain and distress. The aim of this study is to evaluate the efficacy of the combination of EMLA cream and Buzzy device in pain and distress relief during venipuncture or peripheral vascular access in hospitalized children.
The study is an open randomized controlled study. Eligible children will be randomized to receive the application of EMLA cream 60 minutes before the needle procedure or the application of EMLA 60 minutes before the procedure and the use of Buzzy device during procedure.
The primary study outcome will be the mean distress score experienced by children at the moment of the procedure, evaluated with the CEMS scale. Secondary outcomes will be the mean distress score recorded by operators; the self-reported mean pain score; the mean pain score reported by parents and operators.
- Conditions
- Vascular Access
- Being tested
- Buzzy device plus EMLA cream, Only EMLA cream
- Keywords
- Children, Buzzy device, EMLA cream, Peripheral vascular access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy device plus EMLA creamDevice
EMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure
Only EMLA creamDrug
EMLA cream will be applied 60 minutes before the needle procedure
| Study group | Role | What they receive |
|---|---|---|
| Buzzy and EMLA Cream | Experimental | In the experimental group children will receive the application of EMLA cream 60 minutes before the needle procedure and the use of Buzzy device during the procedure. Receives: Device: Buzzy device plus EMLA cream |
| EMLA Cream | Active comparator | In the control group children will receive the application of EMLA cream 60 minutes before the needle procedure Receives: Drug: Only EMLA cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean distress evaluated by parents
Distress score will be recorded by parents through the use of the Children's Emotional Manifestation Scale (CEMS scale). The CEMS scale is an observational scale validated for recording procedural distress in children. It takes into consideration the following characteristics: facial expression, vocalization, activity, interaction, cooperation, with a score ranging from a minimum of 5 (no distress) to a maximum of 25 (serious distress)
Measured: Intraprocedural
Secondary outcomes (5)
Mean distress evaluated by operators
Distress score will be recorded through the use of the Children's Emotional Manifestation Scale (CEMS scale). The CEMS scale is an observational scale validated for recording procedural distress in children. It takes into consideration the following characteristics: facial expression, vocalization, activity, interaction, cooperation, with a score ranging from a minimum of 5 (no distress) to a maximum of 25 (serious distress)
Measured: intraprocedural
Mean pain score evaluated by children
Pain scores will be reported through the Faces Pain Scale Revised (FPS-R scale). The FPS-R algometric scale is appropriate for the detection of pain in children aged 4 to 12 years, as it includes both a series of smiley faces with an expression that changes according to increasing pain, and a numerical scale, for a pain scale ranging from zero (no pain) to 10 (severe pain).
Measured: Immediately after the procedure
Mean pain score evaluated by parents
Pain scores will be reported through the Faces Pain Scale Revised (FPS-R scale). It includes both a series of smiley faces with an expression that changes according to increasing pain, and a numerical scale, for a pain scale ranging from zero (no pain) to 10 (severe pain).
Measured: Immediately after the procedure
Mean pain score evaluated by operators
Pain scores will be reported through the Faces Pain Scale Revised (FPS-R scale). It includes both a series of smiley faces with an expression that changes according to increasing pain, and a numerical scale, for a pain scale ranging from zero (no pain) to 10 (severe pain).
Measured: Immediately after the procedure
Success at first attempt
Percentage of success of the procedure on the first attempt in the two groups
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Apr 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AccessStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara Strajn, Nurse, Principal investigator, Institute for Maternal and Child Health IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695054
- Sponsor's protocol ID
- RC 12/2019
- Status last verified
- Jun 2024
- First submitted
- 31 Dec 2020
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of Buzzy and EMLA Cream for Vascular Access in Children. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04695054
- Acronym / sponsor ID
- RC 12/2019
- Conditions
- Vascular Access
- Keywords
- Children, Buzzy device, EMLA cream, Peripheral vascular access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Jan 2021 (actual)
- 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.
Venepuncture and peripheral intravenous cannulation are commonly performed in children and may cause substantial pain and distress. The aim of this study is to evaluate the efficacy of the combination of EMLA cream and Buzzy device in pain and distress relief during venipuncture or peripheral vascular access in hospitalized children.
The study is an open randomized controlled study. Eligible children will be randomized to receive the application of EMLA cream 60 minutes before the needle procedure or the application of EMLA 60 minutes before the procedure and the use of Buzzy device during procedure.
The primary study outcome will be the mean distress score experienced by children at the moment of the procedure, evaluated with the CEMS scale. Secondary outcomes will be the mean distress score recorded by operators; the self-reported mean pain score; the mean pain score reported by parents and operators.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buzzy and EMLA Cream | Experimental | Device: Buzzy device plus EMLA creamIn the experimental group children will receive the application of EMLA cream 60 minutes before the needle procedure and the use of Buzzy device during the procedure. |
| EMLA Cream | Active comparator | Drug: Only EMLA creamIn the control group children will receive the application of EMLA cream 60 minutes before the needle procedure |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children between 4 and 12yrs of age needing venipuncture or peripheral vascular access
- children who have applied EMLA cream at least 60 minutes before the procedure
Key exclusion criteria (4 listed)
- children with cognitive impairment
- children with skin lesion that does not allow the application of Buzzy device
- children diseases that cause hypersensibility to cold (i.e. Raynaud syndrome, sickle cell disease)
- children who have taken any analgesics in the 8 hours before enrollment
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 |
|---|---|---|
| Buzzy device plus EMLA creamEMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure | Device | Buzzy and EMLA Cream |
| Only EMLA creamEMLA cream will be applied 60 minutes before the needle procedure | Drug | EMLA Cream |
Primary outcome
Mean distress evaluated by parents
Time frame: Intraprocedural
Distress score will be recorded by parents through the use of the Children's Emotional Manifestation Scale (CEMS scale). The CEMS scale is an observational scale validated for recording procedural distress in children. It takes into consideration the following characteristics: facial expression, vocalization, activity, interaction, cooperation, with a score ranging from a minimum of 5 (no distress) to a maximum of 25 (serious distress)
5 secondary outcomes
Mean distress evaluated by operators
Time frame: intraprocedural
Mean pain score evaluated by children
Time frame: Immediately after the procedure
Mean pain score evaluated by parents
Time frame: Immediately after the procedure
Mean pain score evaluated by operators
Time frame: Immediately after the procedure
Success at first attempt
Time frame: Intraprocedural
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 13 Jun 2024.
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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.
Tamara Strajn, Nurse principal investigator
Institute for Maternal and Child Health IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy device plus EMLA cream and Only EMLA cream in people with Vascular Access, run by IRCCS Burlo Garofolo at 1 site 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 2 inclusion and 4 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Mean distress evaluated by parents (time frame: Intraprocedural). 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 13 Jun 2024.