Buzzy Plus EMLA Cream for Vascular Access in Children

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: Vascular Access
• Intervention / Treatment: Device: Buzzy device plus EMLA cream; Drug: Only EMLA cream

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giorgio Cozzi, MD; Phone Number: 00394043785338; Email: giorgio.cozzi@burlo.trieste.it
• Study Contact Backup: Name: Egidio Barbi, prof.; Phone Number: 00390403785251; Email: egidio.barbi@burlo.trieste.it

Study Locations

• Italy
  • TS
    • Trieste, TS, Italy, 34100
      • IRCCS Materno Infantile Burlo Garofolo

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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	Percentage of success of the procedure on the first attempt in the two groups	Intraprocedural

Collaborators and Investigators

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

Study record dates

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): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Children; Buzzy device; EMLA cream; Peripheral vascular access
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Anesthetics, Combined; Lidocaine, Prilocaine Drug Combination
• 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