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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06023368
• Other study ID #: 84569
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: December 23, 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 82
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Drug:
• Num Vapocoolant Spray
Spray applied around port prior to access
• EMLA Cream
cream applied around the port prior to access

Locations

Country	Name	City	State
United States	University of Kentucky DanceBlue Pediatric Hematology/oncology clinic	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Marianne Hutti	Bimeco Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Clinic Wait Time	Wait time will be measured in minutes from check in to check out	Day of visit, up to 8 hours
Primary	Duration of Visit	Total length of overall appointment time measured in minutes	Day of visit, up to 8 hours