Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 82
- 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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Kentucky DanceBlue Pediatric Hematology/oncology clinic
🇺🇸Lexington, Kentucky, United States
University of Kentucky DanceBlue Pediatric Hematology/oncology clinic🇺🇸Lexington, Kentucky, United States