NCT04695054

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

December 31, 2020

Last Update Submit

June 12, 2024

Conditions

Vascular Access

Keywords

ChildrenBuzzy deviceEMLA creamPeripheral vascular access

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Mean distress evaluated by operators

    intraprocedural

  • Mean pain score evaluated by children

    Immediately after the procedure

  • Mean pain score evaluated by parents

    Immediately after the procedure

  • Mean pain score evaluated by operators

    Immediately after the procedure

  • Success at first attempt

    Intraprocedural

Study Arms (2)

Buzzy and EMLA Cream

EXPERIMENTAL

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

ACTIVE COMPARATOR

In the control group children will receive the application of EMLA cream 60 minutes before the needle procedure

Drug: Only EMLA cream

Interventions

Buzzy device plus EMLA creamDEVICE

EMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure

Buzzy and EMLA Cream
Only EMLA creamDRUG

EMLA cream will be applied 60 minutes before the needle procedure

EMLA Cream

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS materno infantile Burlo Garofolo

Trieste, TS, 34100, Italy

Location

Study Officials

  • Tamara Strajn, Nurse

    Institute for Maternal and Child Health IRCCS Burlo Garofolo

    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

December 31, 2020

First Posted

January 5, 2021

Study Start

April 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

June 13, 2024

Record last verified: 2024-06

Locations

IT(1)