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

Vaccination Clinical Trial

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

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03220555
Study type Interventional
Source Nantes University Hospital
Contact
Status Completed
Phase N/A
Start date October 4, 2017
Completion date September 14, 2018
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