30 Participants Needed

Vapocoolant Spray for Injection Pain in Breast Cancer Procedures

ST
Overseen BySanjit Tewari, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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.12345

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.26789

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

ST

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
1Treatment groups
Experimental Treatment
Group I: num VapocoolantExperimental Treatment1 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

Find a Clinic Near You

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

References

Effect of topical alkane vapocoolant spray on pain with intravenous cannulation in patients in emergency departments: randomised double blind placebo controlled trial. [2021]
Randomized controlled trial of topical EMLA and vapocoolant spray for reducing pain during wDPT vaccination. [2018]
Vapocoolant Sprays: Use With Totally Implanted Venous Access Devices. [2019]
Reduction of pain and anxiety prior to botulinum toxin injections with a new topical anesthetic method. [2018]
Vapocoolant spray vs subcutaneous lidocaine injection for reducing the pain of intravenous cannulation: a randomized, controlled, clinical trial. [2022]
Vapocoolant Analgesia for Breast Lymphoscintigraphy: A Prospective Clinical Trial. [2023]
Effectiveness of Vapocoolant Spray on Venipuncture Pain in Young Male Donors: A Randomized Controlled Trial. [2021]
Microcirculatory effect of topical vapocoolants. [2020]
Vapocoolant Anesthesia for Cosmetic Facial Rejuvenation Injections: A Randomized, Prospective, Split-Face Trial. [2020]
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