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

Sponsor
Marianne Hutti (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06023368
Collaborator
Bimeco Group (Other)
82
Enrollment
1
Location
2
Arms
4
Anticipated Duration (Months)
20.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Num Vapocoolant Spray
  • Drug: EMLA Cream
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Port Access Pain [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.

    2. Clinic Wait Time [Day of visit, up to 8 hours]

      Wait time will be measured in minutes from check in to check out

    3. Duration of Visit [Day of visit, up to 8 hours]

      Total length of overall appointment time measured in minutes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kentucky DanceBlue Pediatric Hematology/oncology clinic Lexington Kentucky United States 40506

    Sponsors and Collaborators

    • Marianne Hutti
    • Bimeco Group

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marianne Hutti, Nurse Scientist, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT06023368
    Other Study ID Numbers:
    • 84569
    First Posted:
    Sep 5, 2023
    Last Update Posted:
    Sep 5, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Marianne Hutti, Nurse Scientist, University of Kentucky
    Port access pain
    pediatric
    oncology
    Additional relevant MeSH terms:
    Lidocaine, Prilocaine Drug Combination

    Study Results

    No Results Posted as of Sep 5, 2023