Clinical trial NCT03220555: Efficacy of the Buzzy® Device on the Prevention of Health Care Induced Pediatric Pain in a Vaccination Center
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Injections
Vaccination
Keywords: Buzzy
anesthetic cream
pediatric
pain
venipuncture
vaccination
vibration
cold
distraction
vaccination center
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 220
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Faces Pain Scale revised (FPS-r) for children
timeFrame: Day 0
Secondary outcomes:
measure: Faces Pain Scale revised (FPS-r) for parents
timeFrame: Day 0
measure: Differential cost of the two strategies compared to the differential pain
timeFrame: Day 0
Other outcomes:
Locations:
city: La Roche-sur-Yon
country: France
facility: La Roche sur Yon University Hospital
city: Le Mans
country: France
facility: Le Mans University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Lescop Katia, IDE
role: PRINCIPAL_INVESTIGATOR
References: