Intravenous InjectionsDOLVAXNCT03220555
Efficacy of the Buzzy® Device on the Prevention of Health Care Induced Pediatric Pain in a Vaccination Center
A study testing Buzzy® device and EMLAPATCH (lidocaine, prilocaine) in people with Intravenous Injections and Vaccination, run by Nantes University Hospital at 3 sites in France.
Trial summary
In vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in pediatric patients. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Intravenous Injections, Vaccination
- What is being tested?
- Buzzy® device and EMLAPATCH (lidocaine, prilocaine)
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Oct 2017to 14 Sep 2018
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any child who:
- requires a venipuncture or a vaccination in a vaccination center
- is 4 to 15 years old
- is affiliated to the public social security
- speaks French or is assisted by an translator in the language of the child
- has given his oral consent and whose parents have given it
Who cannot join
- Any child who:
- suffers from sickle cell anemia
- has a contraindication to use lidocaine patch
- requires a Bacille de Calmette et Guérin (BCG) vaccine or tuberculin test
- takes part in another research
- has already participated to this study for another nursing care.
Show all 10Show fewer
- refused to participate or whose parents refused
- has neurological or psychiatric disorders
- has a nerve damage or an abrasion of the skin in terms of puncture or injection area.
- under trusteeship or guardianship (unaccompanied foreign minors).
Trial locations and contacts
3 sites in 1 country.
France3 sites
La Roche sur Yon University Hospital
La Roche-sur-Yon, 85925
Le Mans University Hospital
Le Mans, 72037
Nantes University Hospital
Nantes, 44093
About this study
Official title: Efficacy of a Cold, Vibration, and Distraction Based Medical Device on the Prevention of Health Care Induced Pediatric Pain: a Comparative, Controlled, Randomized and Multicentric Study
In vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in pediatric patients. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses.
The topical anesthetic cream (lidocaine, prilocaine) and the non-pharmacological (distraction and relaxation) interventions which are usually used for prevention of procedural pain impose certain constraints on families and on vaccination centers.
Read more
A distraction and local anesthesia (cold and vibration) based medical device (Buzzy®) could overcome these constraints and could be an interesting alternative for healthcare management in vaccination centers and, in a broader perspective, in other medical services.
Research on this device has been scarce to date. Three of them have shown an efficacy of Buzzy® in comparison to the absence of prevention of vaccination and venipuncture induced pain. An ongoing study will assess the Buzzy® device in comparison to a topical anesthetic cream, but will be set in an emergency department context. To date, no study has compared Buzzy® to topical anesthetic cream on healthy children in a vaccination center.
The research team has formulated the following hypothesis: the Buzzy® device will allow to get a not lower or an equivalent level of pain compared to the level of pain obtained with the usual topical anesthetic cream. The aim of this study is to evaluate the efficacy of the device Buzzy® on vaccination and venipuncture induced pain in a vaccination center.
- Conditions
- Intravenous Injections, Vaccination
- Being tested
- Buzzy® device, EMLAPATCH (lidocaine, prilocaine)
- Keywords
- Buzzy, anesthetic cream, pediatric, pain, venipuncture, vaccination, vibration, cold, distraction, vaccination center
- Medical subject headings
- Pain, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy® deviceDevice
Just before the vaccination or venipuncture the device will be applied on the selected site during 30 seconds and then it will be moved 5 cm above the selected site to make the injection or the puncture. The child will choose if he wants to use the cooling system.
EMLAPATCH (lidocaine, prilocaine)Drug
The patch will be applied during 1 hour to 1 hour and half before the vaccination or venipuncture, on the selected site. After 1 hour to 1 hour and half, it will be removed and the injection or the puncture will be made on the selected site.
| Study group | Role | What they receive |
|---|---|---|
| Buzzy® device | Experimental | Just before the vaccination or venipuncture the device will be applied on the selected site during 30 seconds and then it will be moved 5 cm above the selected site to make the injection or the puncture. The child will choose if he wants to use the cooling system. Receives: Device: Buzzy® device |
| EMLAPATCH (lidocaine, prilocaine) | Active comparator | The patch will be applied during 1 hour to 1 hour and half before the vaccination or venipuncture, on the selected site. After 1 hour to 1 hour and half, it will be removed and the injection or the puncture will be made on the selected site. Receives: Drug: EMLAPATCH (lidocaine, prilocaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faces Pain Scale revised (FPS-r) for children
Pain will be assessed by child using the FPS-r. FPS-r is a tool which has been validated and has been shown to be reliable in intercultural children and adolescents population (4 to 17 years).
Measured: Day 0
Secondary outcomes (2)
Faces Pain Scale revised (FPS-r) for parents
Pain will be assessed by a parent using the FPS-r. FPS-r is a tool which has been validated and has been shown to be reliable in intercultural children and adolescents population (4 to 17 years).
Measured: Day 0
Differential cost of the two strategies compared to the differential pain
Differential cost of the two strategies compared to the differential pain, self-reported by children with the FPS-r. Cost assessment of the two strategies will be made by a micro-costing analysis. The parameters analyzed will be : the strategy used (Buzzy® device or EMLAPATCH), the nurses' time and the time spent by child in the vaccination center. This parameters will be aggregated and will be presented in the form of a cost-effectiveness differential ratio and acceptability curves.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start4 Oct 2017
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
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 Intravenous InjectionsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lescop Katia, IDE, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220555
- Sponsor's protocol ID
- RC17_0035
- Acronym
- DOLVAX
- Status last verified
- Sep 2021
- First submitted
- 12 Jul 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lescop K, Joret I, Delbos P, Briend-Godet V, Blanchi S, Brechet C, Galivel-Voisine A, Coudol S, Volteau C, Riche VP, Cartron E. The effectiveness of the BuzzyⓇ device to reduce or prevent pain in children undergoing needle-related procedures: The results from a prospective, open-label, randomised, non-inferiority study. Int J Nurs Stud. 2021 Jan;113:103803. doi: 10.1016/j.ijnurstu.2020.103803. Epub 2020 Oct 19.
PubMed 33212328
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Cold, Vibration, and Distraction Based Medical Device on the Prevention of Health Care Induced Pediatric Pain: a Comparative, Controlled, Randomized and Multicentric Study
- ClinicalTrials.gov ID
- NCT03220555
- Acronym / sponsor ID
- DOLVAX / RC17_0035
- Conditions
- Intravenous Injections, Vaccination
- Keywords
- Buzzy, anesthetic cream, pediatric, pain, venipuncture, vaccination, vibration, cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 18 Jul 2017 (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.
In vaccination centers, venipunctures and vaccinations are sources of pain and anxiety in pediatric patients. Prior painful experiences can reduce the acceptance of later health care, hence making it more difficult for both patients and nurses.
The topical anesthetic cream (lidocaine, prilocaine) and the non-pharmacological (distraction and relaxation) interventions which are usually used for prevention of procedural pain impose certain constraints on families and on vaccination centers.
A distraction and local anesthesia (cold and vibration) based medical device (Buzzy®) could overcome these constraints and could be an interesting alternative for healthcare management in vaccination centers and, in a broader perspective, in other medical services.
Research on this device has been scarce to date. Three of them have shown an efficacy of Buzzy® in comparison to the absence of prevention of vaccination and venipuncture induced pain. An ongoing study will assess the Buzzy® device in comparison to a topical anesthetic cream, but will be set in an emergency department context. To date, no study has compared Buzzy® to topical anesthetic cream on healthy children in a vaccination center.
The research team has formulated the following hypothesis: the Buzzy® device will allow to get a not lower or an equivalent level of pain compared to the level of pain obtained with the usual topical anesthetic cream. The aim of this study is to evaluate the efficacy of the device Buzzy® on vaccination and venipuncture induced pain in a vaccination center.
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® deviceJust before the vaccination or venipuncture the device will be applied on the selected site during 30 seconds and then it will be moved 5 cm above the selected site to make the injection or the puncture. The child will choose if he wants to use the cooling system. |
| EMLAPATCH (lidocaine, prilocaine) | Active comparator | Drug: EMLAPATCH (lidocaine, prilocaine)The patch will be applied during 1 hour to 1 hour and half before the vaccination or venipuncture, on the selected site. After 1 hour to 1 hour and half, it will be removed and the injection or the puncture will be made on the selected site. |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- requires a venipuncture or a vaccination in a vaccination center
- is 4 to 15 years old
- is affiliated to the public social security
- speaks French or is assisted by an translator in the language of the child
- has given his oral consent and whose parents have given it
Key exclusion criteria (10 listed)
- suffers from sickle cell anemia
- has a contraindication to use lidocaine patch
- requires a Bacille de Calmette et Guérin (BCG) vaccine or tuberculin test
- takes part in another research
- has already participated to this study for another nursing care.
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® deviceJust before the vaccination or venipuncture the device will be applied on the selected site during 30 seconds and then it will be moved 5 cm above the selected site to make the injection or the puncture. The child will choose if he wants to use the cooling system. | Device | Buzzy® device |
| EMLAPATCH (lidocaine, prilocaine)The patch will be applied during 1 hour to 1 hour and half before the vaccination or venipuncture, on the selected site. After 1 hour to 1 hour and half, it will be removed and the injection or the puncture will be made on the selected site. | Drug | EMLAPATCH (lidocaine, prilocaine) |
Primary outcome
Faces Pain Scale revised (FPS-r) for children
Time frame: Day 0
Pain will be assessed by child using the FPS-r. FPS-r is a tool which has been validated and has been shown to be reliable in intercultural children and adolescents population (4 to 17 years).
2 secondary outcomes
Faces Pain Scale revised (FPS-r) for parents
Time frame: Day 0
Differential cost of the two strategies compared to the differential pain
Time frame: Day 0
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 14 Sep 2026.
- Results publication: PubMed 33212328Lescop K, Joret I, Delbos P, Briend-Godet V, Blanchi S, Brechet C, Galivel-Voisine A, Coudol S, Volteau C, Riche VP, Cartron E. The effectiveness of the BuzzyⓇ device to reduce or prevent pain in children undergoing needle-related procedures: The results from a prospective, open-label, randomised, non-inferiority study. Int J Nurs Stud. 2021 Jan;113:103803. doi: 10.1016/j.ijnurstu.2020.103803. Epub 2020 Oct 19.
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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.
Lescop Katia, IDE principal investigator
Nantes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy® device and EMLAPATCH (lidocaine, prilocaine) in people with Intravenous Injections and Vaccination, run by Nantes University Hospital at 3 sites in France.
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 6 inclusion and 10 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 14 Sep 2026. 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 France. 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?
Faces Pain Scale revised (FPS-r) for children (time frame: Day 0). 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 NCT03220555, 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 14 Sep 2026.