Vapocoolant Analgesia for Breast Lymphoscintigraphy

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05744557

Enrollment

Registered

2023-02-27

Start date

2023-03-01

Completion date

2025-05-13

Last updated

2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

To learn if applying vapocoolant anesthetic spray (Nüm) on the surface of the intended injection site will reduce the pain/anxiety associated with breast injections.

Detailed description

Primary Objectives: 1. Establish feasibility of topical vapocoolant in the setting of breast lymphoscintigraphy. 2. Demonstrate safety of topical vapocoolant in the setting of breast lymphoscintigraphy. Secondary Objectives: 1. To assess patient pain intensity associated with the performance of breast lymphoscintigraphy. 2. To evaluate the attitude from patients about supporting the continued offering of topical vapocoolant in the breast lymphoscintigraphy clinic.

Interventions

OTHERnum Vapocoolant

Spray will be administered for 4 to 6 seconds from a distance of 3 to 6 inches to desired sites of skin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Any adult patient undergoing asubareolar breast lymphoscintigraphy injection will be eligible. * Age ≥18 years old * Ability to understand and the willingness to sign a written informed consent document. * Childbearing potential, lactating, pregnant women will be included.

Exclusion criteria

* Patients who have allergy or had prior hypersensitivity to either of the vapocoolants including 1,1,1,3,3 Pentafluoropropane and 1,1,1,2-Tetrafluoroethane. * Patients with uncontrolled intercurrent illness (insulin dependent and non-insulin dependent diabetes) * Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Design outcomes

Primary

Measure	Time frame
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	through study completion; an average of 1 year.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026