Status:

WITHDRAWN

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

Lead Sponsor:

Marianne Hutti

Collaborating Sponsors:

Bimeco Group

Conditions:

Pediatric Cancer

Eligibility:

All Genders

4-18 years

Phase:

PHASE4

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 rat...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 23 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 20 2024

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT06023368

Start Date

December 23 2023

End Date

June 20 2024

Last Update

November 14 2024

Active Locations (1)

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1

University of Kentucky DanceBlue Pediatric Hematology/oncology clinic

Lexington, Kentucky, United States, 40506