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Completed

NCT Number: NCT04695054

Buzzy Plus EMLA Cream for Vascular Access in Children

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.

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Key information

Conditions

Vascular Access

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS materno infantile Burlo Garofolo

Trieste, TS, 34100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buzzy device plus EMLA cream

Device

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

Only EMLA cream

Drug

EMLA cream will be applied 60 minutes before the needle procedure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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).

  3. 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).

  4. 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).

  5. Success at first attempt

    Time frame: Intraprocedural

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

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2021
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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