Pain ReliefPhase 3NCT02434731
Vibration and Cold for Pain Relief During Peripheral Intravenous Cannulation in Children With Intellectual Disability
A Phase 3 study testing Buzzy® device in people with Pain Relief, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Needle procedures are the most common and important source of pain and distress in children in the health care setting. Children with intellectual disability from any cause experience pain more frequently than healthy children. They often require venipuncture or IV cannulation for diagnostic or therapeutic procedures. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Pain Relief
- What is being tested?
- Buzzy® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2015to Jun 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4 to 17 years
- Presence of intellectual disability
- Need of peripheral IV line or venipuncture
- Informed consent signed by parents or legal guardians
Who cannot join
- Presence of abrasion, infection or break in skin in the area of Buzzy® placement
- Cold hypersensibility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Evaluate the Effectiveness of Vibration and External Cold (Buzzy Device) for Pain Relief During Venipuncture or Intravenous Cannulation in Children With Intellectual Disability.
Needle procedures are the most common and important source of pain and distress in children in the health care setting. Children with intellectual disability from any cause experience pain more frequently than healthy children. They often require venipuncture or IV cannulation for diagnostic or therapeutic procedures. Pain in this population is often unrecognised because these patients are frequently unable to self-report their pain. Now it's possible to measure pain in children with intellectual disability with specific pain scales, like NCCPC-PV (Non-Communicating Children's Pain Checklist, Post-operative Version).
The efficacy of a device combining vibration and cold for pain relief during venipuncture or IV cannulation has been recently reported in children. The device's actions are based on the Gate Control Theory, whereby cold and vibrations stimulate large fiber and inhibitory neurons to interrupt nociception. This non-pharmacologic technique for pain relief could be useful in this kind of patients in emergency department. To date, there is no study that validated Buzzy device for pain relief in children with intellectual disability.
The aim of this study is to test the effectiveness of Buzzy® (a device that provides cold and vibration), in reducing the pain during venipuncture or IV cannulation, in children with intellectual disability.
- Conditions
- Pain Relief
- Being tested
- Buzzy® device
- Keywords
- Procedural pain, Phlebotomy, Intellectual Disability, Child, Buzzy
- Medical subject headings
- Pain, Procedural, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy® deviceDevice
Buzzy® is a battery-powered device for venipuncture pain relief combining cold, vibration, and distraction.
| Study group | Role | What they receive |
|---|---|---|
| Buzzy® device | Experimental | The Buzzy® device will be applied just above the selected site of the venipuncture; a ice pack will be attached under the device; the device will be turned on and after 15 second the procedure will be carried out. Receives: Device: Buzzy® device |
| No intervention | No intervention | No intervention for pain relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (NCCPC-PV scale)
The pain during the procedure will be evaluated using the NCCPC-PV scale (Non-communicating Children's Pain Checklist - Postoperative Version) administered by a nurse
Measured: intraoperative
Secondary outcomes (3)
Success at first attempt
Percentage of success at first attempt
Measured: intraoperative
Number of attempts required
Total number of attempts required
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 posted5 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 71 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, ItalySilvana Schreiber, RN, Study director, IRCCS Burlo Garofolo, Trieste, ItalyGiorgio Cozzi, MD, Principal investigator, IRCCS Burlo Garofolo, Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434731
- Sponsor's protocol ID
- RC 20/13
- Status last verified
- Aug 2015
- First submitted
- 27 Apr 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schreiber S, Cozzi G, Rutigliano R, Assandro P, Tubaro M, Cortellazzo Wiel L, Ronfani L, Barbi E. Analgesia by cooling vibration during venipuncture in children with cognitive impairment. Acta Paediatr. 2016 Jan;105(1):e12-6. doi: 10.1111/apa.13224. Epub 2015 Nov 4.
PubMed 26401633
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Effectiveness of Vibration and External Cold (Buzzy Device) for Pain Relief During Venipuncture or Intravenous Cannulation in Children With Intellectual Disability.
- ClinicalTrials.gov ID
- NCT02434731
- Acronym / sponsor ID
- RC 20/13
- Conditions
- Pain Relief
- Keywords
- Procedural pain, Phlebotomy, Intellectual Disability, Child, Buzzy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 May 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 procedures are the most common and important source of pain and distress in children in the health care setting. Children with intellectual disability from any cause experience pain more frequently than healthy children. They often require venipuncture or IV cannulation for diagnostic or therapeutic procedures. Pain in this population is often unrecognised because these patients are frequently unable to self-report their pain. Now it's possible to measure pain in children with intellectual disability with specific pain scales, like NCCPC-PV (Non-Communicating Children's Pain Checklist, Post-operative Version).
The efficacy of a device combining vibration and cold for pain relief during venipuncture or IV cannulation has been recently reported in children. The device's actions are based on the Gate Control Theory, whereby cold and vibrations stimulate large fiber and inhibitory neurons to interrupt nociception. This non-pharmacologic technique for pain relief could be useful in this kind of patients in emergency department. To date, there is no study that validated Buzzy device for pain relief in children with intellectual disability.
The aim of this study is to test the effectiveness of Buzzy® (a device that provides cold and vibration), in reducing the pain during venipuncture or IV cannulation, in children with intellectual disability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buzzy® device | Experimental | Device: Buzzy® deviceThe Buzzy® device will be applied just above the selected site of the venipuncture; a ice pack will be attached under the device; the device will be turned on and after 15 second the procedure will be carried out. |
| No intervention | No intervention | –No intervention for pain relief |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 4 to 17 years
- Presence of intellectual disability
- Need of peripheral IV line or venipuncture
- Informed consent signed by parents or legal guardians
Key exclusion criteria (2 listed)
- Presence of abrasion, infection or break in skin in the area of Buzzy® placement
- Cold hypersensibility
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® deviceBuzzy® is a battery-powered device for venipuncture pain relief combining cold, vibration, and distraction. | Device | Buzzy® device |
Primary outcome
Pain score (NCCPC-PV scale)
Time frame: intraoperative
The pain during the procedure will be evaluated using the NCCPC-PV scale (Non-communicating Children's Pain Checklist - Postoperative Version) administered by a nurse
3 secondary outcomes
Success at first attempt
Time frame: intraoperative
Number of attempts required
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 6 Aug 2015.
- Derived from this study: PubMed 26401633Schreiber S, Cozzi G, Rutigliano R, Assandro P, Tubaro M, Cortellazzo Wiel L, Ronfani L, Barbi E. Analgesia by cooling vibration during venipuncture in children with cognitive impairment. Acta Paediatr. 2016 Jan;105(1):e12-6. doi: 10.1111/apa.13224. Epub 2015 Nov 4.
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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
Silvana Schreiber, RN study director
IRCCS Burlo Garofolo, Trieste, Italy
Giorgio Cozzi, MD principal investigator
IRCCS Burlo Garofolo, Trieste, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buzzy® device in people with Pain Relief, 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 4 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 6 Aug 2015. 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.
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?
Pain score (NCCPC-PV scale) (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02434731, which also lists 1 linked publication.
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 6 Aug 2015.