Buzzy Plus EMLA Cream for Vascular Access in Children

Vascular Access Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04695054
• Other study ID #: RC 12/2019
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2024
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Vascular Access

Intervention

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

Drug:
• Only EMLA cream
EMLA cream will be applied 60 minutes before the needle procedure

Locations

Country	Name	City	State
Italy	IRCCS materno infantile Burlo Garofolo	Trieste	TS

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Success at first attempt	Percentage of success of the procedure on the first attempt in the two groups	Intraprocedural