Vapocoolant Analgesia for Breast Lymphoscintigraphy

M.D. Anderson Cancer Center30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

num VapocoolantOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame: through study completion; an average of 1 year.

Data from ClinicalTrials.gov

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