Vapocoolant Spray for Injection Pain in Breast Cancer Procedures

Overseen By Sanjit Tewari, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Diabetes, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is vapocoolant spray safe for use in humans?

Vapocoolant sprays have been studied for safety in various medical procedures, such as reducing pain during injections and intravenous cannulation. These studies generally support their safe use in humans, although specific safety data for breast cancer procedures is not detailed. ^{1 2 3 4 5}

How does the treatment Nüm Vapocoolant differ from other treatments for injection pain in breast cancer procedures?

Nüm Vapocoolant is unique because it provides quick pain relief through skin cooling by evaporation, which is different from other treatments that may use topical anesthetics or no pain relief at all. This method is particularly novel for breast cancer procedures, where pain management options are limited. ^{2 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Sanjit Tewari, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 who are undergoing a breast lymphoscintigraphy injection, which helps stage breast cancer. It's open to those able to consent and includes pregnant or lactating women. People with uncontrolled illnesses like diabetes, mental health conditions affecting study compliance, or allergies to vapocoolants can't participate.

Inclusion Criteria

I am an adult scheduled for a specific breast lymph node mapping procedure.

Ability to understand and the willingness to sign a written informed consent document

Childbearing potential, lactating, pregnant women will be included

Exclusion Criteria

I do not have uncontrolled diabetes.

Patients with psychiatric illness/social situations that would limit compliance with study requirements

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of vapocoolant anesthetic spray to reduce pain/anxiety during breast lymphoscintigraphy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Nüm

Trial Overview The trial is testing if a cooling spray anesthetic called 'Nüm' can lessen the pain and anxiety when getting a breast injection for cancer staging. Participants will receive this vapocoolant before their scheduled procedure.

Participant Groups

Group I: num Vapocoolant Experimental Treatment 1 Intervention

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

Nüm is already approved in United States for the following indications:

Approved in United States as Nüm for:

• Minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses)
• Injections (venipuncture, IV starts)
• Temporary relief of minor sports injuries

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Gilero, LLC

Collaborator

Trials

1

Recruited

30+

Findings from Research

A randomized double-blind trial involving 201 adults showed that a topical alkane vapocoolant significantly reduced pain during intravenous cannulation, with median pain scores of 12 mm for the vapocoolant group compared to 36 mm for the control group (P<0.001).

The vapocoolant was found to be safe and well-accepted, with 62% of patients preferring it for future use, and only two cases of transient skin redness reported at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. Hijazi, R., Taylor, D., Richardson, J.[2021]

In a study involving 90 infants receiving their first wDPT vaccination, the use of EMLA cream or vapocoolant spray alongside breastfeeding did not significantly reduce the duration of crying after vaccination compared to breastfeeding alone.

However, both EMLA and vapocoolant spray resulted in significantly lower pain scores, indicating they may effectively reduce perceived pain during vaccination, warranting further research into their use as pain relief methods for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of topical EMLA and vapocoolant spray for reducing pain during wDPT vaccination. Gupta, NK., Upadhyay, A., Dwivedi, AK., et al.[2018]

Vapocoolant sprays are used to manage pain during the access of totally implanted venous access devices (TIVADs), but there is currently no clear indication or contraindication for their use, highlighting a gap in clinical guidelines.

The article aims to evaluate the safety and effectiveness of vapocoolant sprays in the TIVAD access process, emphasizing the need for best practices that consider product use, institutional policies, and individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vapocoolant Sprays: Use With Totally Implanted Venous Access Devices. Bostelman, C.[2019]

In a study involving 52 patients, the use of vapocoolants significantly reduced pain during cosmetic botulinum injections compared to no treatment, with a p-value of less than 0.001 indicating strong statistical significance.

Approximately 67% of patients reported that vapocoolants caused less pain than no anesthesia, and 54% preferred this method for future treatments, highlighting its efficacy in improving patient comfort and reducing anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of pain and anxiety prior to botulinum toxin injections with a new topical anesthetic method. Weiss, RA., Lavin, PT.[2018]

In a study involving 220 adult patients, the topical vapocoolant alkane spray resulted in significantly less pain during the administration of the anesthetic compared to 1% lidocaine (0 mm vs 11 mm), and it also led to lower pain scores during the actual cannulation (9 mm vs 0 mm).

The vapocoolant spray demonstrated higher success rates for cannulation (83.6% vs 67.3%) and required less time to administer (9 seconds vs 84.5 seconds), making it a more convenient option for healthcare providers in emergency settings, despite slightly less effectiveness in pain reduction compared to lidocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. Page, DE., Taylor, DM.[2022]

In a study of 30 patients undergoing breast lymphoscintigraphy, the use of vapocoolant analgesia resulted in a successful procedure rate of 100% and an average self-reported pain score of only 1.98, indicating low pain levels during the injection process.

The application of vapocoolant did not compromise the effectiveness of lymphoscintigraphy, suggesting it is a feasible option for reducing pain in this procedure for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vapocoolant Analgesia for Breast Lymphoscintigraphy: A Prospective Clinical Trial. Tewari, SO., Tamirisa, N., Xu, G., et al.[2023]

In a study involving 88 young male blood donors, the use of vapocoolant spray significantly reduced pain during venipuncture, with an average pain score of 1.90 for the spray group compared to 3.23 for the control group (P = .02).

The results indicate that vapocoolant spray is an effective pain management technique for blood donation, enhancing the comfort of donors during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors: A Randomized Controlled Trial. Basak, T., Aciksoz, S., Savasci, U., et al.[2021]

In a study involving 50 rats, the use of vapocoolant sprays showed no significant changes in vessel diameter or capillary density, indicating that these sprays are safe for microcirculation during minor medical procedures.

Despite initial decreases in vessel diameter and capillary density, the overall lack of significant changes in inflammatory markers suggests that vapocoolant sprays do not adversely affect cutaneous blood flow or induce inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microcirculatory effect of topical vapocoolants. Galdyn, I., Swanson, E., Gordon, C., et al.[2020]

In a study involving 30 subjects (15 receiving filler injections and 15 receiving neurotoxin injections), the use of vapocoolant spray significantly reduced perceived pain during cosmetic facial procedures, with a 59% decrease for neurotoxin and a 64% decrease for filler injections.

The results were statistically significant (P < .05), indicating that vapocoolant technology is an effective method to enhance patient comfort during minimally invasive cosmetic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vapocoolant Anesthesia for Cosmetic Facial Rejuvenation Injections: A Randomized, Prospective, Split-Face Trial. Zeiderman, MR., Kelishadi, SS., Tutela, JP., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of topical EMLA and vapocoolant spray for reducing pain during wDPT vaccination. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Vapocoolant Sprays: Use With Totally Implanted Venous Access Devices. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Reduction of pain and anxiety prior to botulinum toxin injections with a new topical anesthetic method. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Vapocoolant Analgesia for Breast Lymphoscintigraphy: A Prospective Clinical Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors: A Randomized Controlled Trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Microcirculatory effect of topical vapocoolants. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Vapocoolant Anesthesia for Cosmetic Facial Rejuvenation Injections: A Randomized, Prospective, Split-Face Trial. [2020]