Vapocoolant Analgesia for Breast Lymphoscintigraphy

M.D. Anderson Cancer Center

Status: Terminated

Conditions: Breast Cancer

Treatments: Other: num Vapocoolant

Study type: Interventional

Funder types: Other

Identifiers

NCT05744557

NCI-2023-01629 (Other Identifier)

2022-0454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

num Vapocoolant

Experimental group

Description:

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

Treatment:

Other: num Vapocoolant