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

Phase 4

Withdrawn

• Conditions: Pediatric Cancer
• Interventions: Drug: EMLA Cream; Drug: Num Vapocoolant Spray

• Registration Number: NCT06023368
• Lead Sponsor: Marianne Hutti

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-05
• Study Start: 2023-12-23
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMLA Cream	EMLA Cream	Numbing (EMLA) cream will be applied around the port.
Sterile Vapocoolant Spray	Num Vapocoolant Spray	Num vapocoolant spray will be administered as a single use canister around the port

Primary Outcome Measures

Name	Time	Method
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.
Clinic Wait Time	Day of visit, up to 8 hours	Wait time will be measured in minutes from check in to check out
Duration of Visit	Day of visit, up to 8 hours	Total length of overall appointment time measured in minutes

Trial Locations

Locations (1)

University of Kentucky DanceBlue Pediatric Hematology/oncology clinic; 🇺🇸 Lexington, Kentucky, United States