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

NCT03220555 | Completed DMC

• 1 other identifier: RC17_0035
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

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.

Conditions

Intravenous Injections; Vaccination

Keywords

Buzzy; anesthetic cream; pediatric; pain; venipuncture; vaccination; vibration; cold; distraction; vaccination center

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 0

Secondary Outcomes (2)

• Faces Pain Scale revised (FPS-r) for parents

  Day 0

• Differential cost of the two strategies compared to the differential pain

  Day 0

Study Arms (2)

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.

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.

Drug: EMLAPATCH (lidocaine, prilocaine)

Interventions

Buzzy® device 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.

Buzzy® device

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.

EMLAPATCH (lidocaine, prilocaine)

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

La Roche sur Yon University Hospital

La Roche-sur-Yon, 85925, France

Location

Le Mans University Hospital

Le Mans, 72037, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Pain; Common Cold

Interventions

Lidocaine; Prilocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Lescop Katia, IDE

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 18, 2017
• Study Start: October 4, 2017
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

FR (3)