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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pediatric Cancer

Intervention / Treatment
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* Drug: Num Vapocoolant Spray
* Drug: EMLA Cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sterile Vapocoolant Spray<br>Num vapocoolant spray will be administered as a single use canister around the port | Drug: Num Vapocoolant Spray<br>* Spray applied around port prior to access<br>* Other names: Vapocoolant Spray;|
| Active Comparator: EMLA Cream<br>Numbing (EMLA) cream will be applied around the port. | Drug: EMLA Cream<br>* cream applied around the port prior to access<br>* Other names: numbing cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Port access pain, pediatric, oncology