Efficacy of the Buzzy® Device on the Prevention of Health Care Induced Pediatric Pain in a Vaccination Center

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-04

Study Completion Date

2018-09-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief

NCT01394250

Pain Anxiety

COMPLETED PHASE2

A Test of the Effectiveness of a Device and Distraction for Pediatric Immunization Pain

NCT01152489

Procedural Pain

COMPLETED PHASE2/PHASE3

Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in in Children

NCT05857033

Anesthesia, Local

UNKNOWN NA

Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

NCT00919100

Pain

COMPLETED NA

Comparing Buzzy Device With Emla Cream in Needle Related Pain

NCT05354739

Procedural Pain

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intravenous Injections Vaccination

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Buzzy® device

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.

Group Type EXPERIMENTAL

Buzzy® device

Intervention Type DEVICE

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)

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.

Group Type ACTIVE_COMPARATOR

EMLAPATCH (lidocaine, prilocaine)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Buzzy® device

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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.
* 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).

Minimum Eligible Age

4 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No