Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-23

Study Completion Date

2024-06-20

Brief Summary

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The goal of this clinical trial is to compare a sterile vapocoolant spray to EMLA cream in children with access ports.

Participants will receive either the spray or cream prior to port access and rate pain on a scale.

Researchers will compare spray vs cream to see if the spray is as effective as the cream in reducing pain associated with port puncture.

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Detailed Description

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Conditions

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Pediatric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Sterile Vapocoolant Spray

Num vapocoolant spray will be administered as a single use canister around the port

Group Type EXPERIMENTAL

Num Vapocoolant Spray

Intervention Type DRUG

Spray applied around port prior to access

EMLA Cream

Numbing (EMLA) cream will be applied around the port.

Group Type ACTIVE_COMPARATOR

EMLA Cream

Intervention Type DRUG

cream applied around the port prior to access

Interventions

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Num Vapocoolant Spray

Spray applied around port prior to access

Intervention Type DRUG

EMLA Cream

cream applied around the port prior to access

Intervention Type DRUG

Other Intervention Names

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Vapocoolant Spray numbing cream

Eligibility Criteria

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Inclusion Criteria

* English-speaking
* Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy
* EMLA cream has (standard of care) or has not (vapocoolant) been applied to the port site prior to the appointment
* Previous allergic reaction or skin irritation due to EMLA
* Quick access to the child's port is needed for drawing blood, or giving treatments, blood products, or drugs such as chemotherapy

Exclusion Criteria

* Child has a legal guardian or non-parent family member as the only adult with them for the visit.
* Children less than 4 years of age
* Children with altered mental status
* History of traumatic brain injury, developmental delay or autism
* Child is nonverbal
* Present appointment is for drawing blood, receiving intravenous antibiotics, blood products, or chemotherapy, and child and parents prefer to wait for EMLA cream to take effect.

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No