Pediatric Cancer
Conditions
Keywords
Port access pain, pediatric, oncology
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.
Interventions
Spray applied around port prior to access
DRUGEMLA Cream
cream applied around the port prior to access
Sponsors
Bimeco Group
Marianne Hutti
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed