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

M

Marianne Hutti

Status and phase

Withdrawn
Phase 4

Conditions

Pediatric Cancer

Treatments

Drug: EMLA Cream
Drug: Num Vapocoolant Spray

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Sterile Vapocoolant Spray
Experimental group
Description:
Num vapocoolant spray will be administered as a single use canister around the port
Treatment:
Drug: Num Vapocoolant Spray
EMLA Cream
Active Comparator group
Description:
Numbing (EMLA) cream will be applied around the port.
Treatment:
Drug: EMLA Cream

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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