Vapocoolant Analgesia for Breast Lymphoscintigraphy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-05-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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num Vapocoolant

vapocoolant anesthetic spray (a spray that cools and numbs the skin) to control pain during minor surgical procedures (such as lancing boils, incisions, injections and IV placements) and minor sport injuries

Group Type EXPERIMENTAL

num Vapocoolant

Intervention Type OTHER

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

Interventions

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num Vapocoolant

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No