Buzzy Plus EMLA Cream for Vascular Access in Children

June 12, 2024 updated by: IRCCS Burlo Garofolo

Combined Use of Buzzy and EMLA Cream for Vascular Access in Children. A Randomized Controlled Trial

Venepuncture and peripheral intravenous cannulation are commonly performed in children and may cause substantial pain and distress. The aim of this study is to evaluate the efficacy of the combination of EMLA cream and Buzzy device in pain and distress relief during venipuncture or peripheral vascular access in hospitalized children.

The study is an open randomized controlled study. Eligible children will be randomized to receive the application of EMLA cream 60 minutes before the needle procedure or the application of EMLA 60 minutes before the procedure and the use of Buzzy device during procedure.

The primary study outcome will be the mean distress score experienced by children at the moment of the procedure, evaluated with the CEMS scale. Secondary outcomes will be the mean distress score recorded by operators; the self-reported mean pain score; the mean pain score reported by parents and operators.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • TS
      • Trieste, TS, Italy, 34100
        • IRCCS materno infantile Burlo Garofolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • children between 4 and 12yrs of age needing venipuncture or peripheral vascular access
  • children who have applied EMLA cream at least 60 minutes before the procedure

Exclusion Criteria:

  • children with cognitive impairment
  • children with skin lesion that does not allow the application of Buzzy device
  • children diseases that cause hypersensibility to cold (i.e. Raynaud syndrome, sickle cell disease)
  • children who have taken any analgesics in the 8 hours before enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buzzy and EMLA Cream
In the experimental group children will receive the application of EMLA cream 60 minutes before the needle procedure and the use of Buzzy device during the procedure.
Device: Buzzy device plus EMLA cream
EMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure
Active Comparator: EMLA Cream
In the control group children will receive the application of EMLA cream 60 minutes before the needle procedure
Drug: Only EMLA cream
EMLA cream will be applied 60 minutes before the needle procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean distress evaluated by parents
Time Frame: Intraprocedural
Distress score will be recorded by parents through the use of the Children's Emotional Manifestation Scale (CEMS scale). The CEMS scale is an observational scale validated for recording procedural distress in children. It takes into consideration the following characteristics: facial expression, vocalization, activity, interaction, cooperation, with a score ranging from a minimum of 5 (no distress) to a maximum of 25 (serious distress)
Intraprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean distress evaluated by operators
Time Frame: intraprocedural
Distress score will be recorded through the use of the Children's Emotional Manifestation Scale (CEMS scale). The CEMS scale is an observational scale validated for recording procedural distress in children. It takes into consideration the following characteristics: facial expression, vocalization, activity, interaction, cooperation, with a score ranging from a minimum of 5 (no distress) to a maximum of 25 (serious distress)
intraprocedural
Mean pain score evaluated by children
Time Frame: Immediately after the procedure
Pain scores will be reported through the Faces Pain Scale Revised (FPS-R scale). The FPS-R algometric scale is appropriate for the detection of pain in children aged 4 to 12 years, as it includes both a series of smiley faces with an expression that changes according to increasing pain, and a numerical scale, for a pain scale ranging from zero (no pain) to 10 (severe pain).
Immediately after the procedure
Mean pain score evaluated by parents
Time Frame: Immediately after the procedure
Pain scores will be reported through the Faces Pain Scale Revised (FPS-R scale). It includes both a series of smiley faces with an expression that changes according to increasing pain, and a numerical scale, for a pain scale ranging from zero (no pain) to 10 (severe pain).
Immediately after the procedure
Mean pain score evaluated by operators
Time Frame: Immediately after the procedure
Pain scores will be reported through the Faces Pain Scale Revised (FPS-R scale). It includes both a series of smiley faces with an expression that changes according to increasing pain, and a numerical scale, for a pain scale ranging from zero (no pain) to 10 (severe pain).
Immediately after the procedure
Success at first attempt
Time Frame: Intraprocedural
Percentage of success of the procedure on the first attempt in the two groups
Intraprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Burlo Garofolo

Investigators

  • Principal Investigator: Tamara Strajn, Nurse, Institute for Maternal and Child Health IRCCS Burlo Garofolo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 31, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 12/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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