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

March 15, 2024 updated by: Marianne Hutti

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky DanceBlue Pediatric Hematology/oncology clinic
        • Contact:
          • Kimberly Parks, MSN, RN
        • Contact:
          • Marianne Hutti, PhD, APRN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sterile Vapocoolant Spray
Num vapocoolant spray will be administered as a single use canister around the port
Drug: Num Vapocoolant Spray
Spray applied around port prior to access
Other Names:
  • Vapocoolant Spray
Active Comparator: EMLA Cream
Numbing (EMLA) cream will be applied around the port.
Drug: EMLA Cream
cream applied around the port prior to access
Other Names:
  • numbing cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Port Access Pain
Time Frame: Within 5 minutes of port access
Pain will be measured by The Faces Pain Scale - Revised (FPS-R). FPS-R is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric. Higher scores mean increased pain.
Within 5 minutes of port access
Clinic Wait Time
Time Frame: Day of visit, up to 8 hours
Wait time will be measured in minutes from check in to check out
Day of visit, up to 8 hours
Duration of Visit
Time Frame: Day of visit, up to 8 hours
Total length of overall appointment time measured in minutes
Day of visit, up to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marianne Hutti

Collaborators

Bimeco Group

Investigators

  • Principal Investigator: Marianne Hutti, PhD, APRN, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84569

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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