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

NCT06023368 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 84569
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Cancer

Keywords

Port access pain; pediatric; oncology

Outcome Measures

Primary Outcomes (3)

• Port Access Pain

  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

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

  Day of visit, up to 8 hours

• Duration of Visit

  Total length of overall appointment time measured in minutes

  Day of visit, up to 8 hours

Study Arms (2)

Sterile Vapocoolant Spray

EXPERIMENTAL

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

Drug: Num Vapocoolant Spray

EMLA Cream

ACTIVE COMPARATOR

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

Drug: EMLA Cream

Interventions

Num Vapocoolant Spray DRUG

Spray applied around port prior to access

Also known as: Vapocoolant Spray

Sterile Vapocoolant Spray

EMLA Cream DRUG

cream applied around the port prior to access

Also known as: numbing cream

EMLA Cream

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marianne Hutti: lead
• Bimeco Group: collaborator

Study Sites (1)

University of Kentucky DanceBlue Pediatric Hematology/oncology clinic

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Marianne Hutti, PhD, APRN

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: December 23, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)