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

• Status: Completed
• Trial end date: 2018-09-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Lidocaine; Prilocaine

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).