Vapocoolant Spray for Pain Relief

Recruiting at 2 trial locations

Overseen By Mary Tschann, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Queen's Medical Center

Must not be taking: Narcotics, Anxiolytics

Disqualifiers: Previous vapocoolant exposure, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a vapocoolant spray can reduce pain when injecting a local anesthetic (lidocaine) during the insertion of a Nexplanon implant, a birth control device. Participants will receive either the Pain Ease vapocoolant spray or a placebo spray, which lacks pain relief effects, to determine any difference in pain levels. The trial is open to individuals at least 14 years old who speak English and are having the Nexplanon implant inserted in a specific medical suite. This study aims to determine if the spray makes the procedure more comfortable for patients. As an unphased trial, it offers participants the opportunity to contribute to research that could enhance comfort during medical procedures.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this vapocoolant spray is safe for pain relief during procedures?

Research has shown that vapocoolant spray is generally safe for reducing pain. Studies have found it effective in lowering pain during needle procedures for both adults and children. Importantly, these studies reported no serious side effects from the spray. The FDA has approved the Pain Ease vapocoolant spray for use on the skin before procedures like starting an IV or getting a vaccination. This approval indicates a good safety record in similar situations. Overall, the spray is well-tolerated, making it a promising option for pain relief during procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using vapocoolant spray for pain relief because it offers a quick and non-invasive way to reduce pain. Unlike standard treatments for pain during procedures, such as lidocaine injections that can take time to work, the vapocoolant spray acts instantly by cooling the skin, which can help numb the area before the needle is even used. This method is unique because it provides immediate pain relief without the need for additional medications or waiting time.

What evidence suggests that vapocoolant spray is effective for pain relief during Nexplanon insertion?

Research has shown that a vapocoolant spray, which participants in this trial may receive, can reduce pain before needle procedures, such as starting an IV. For instance, one study found that people experienced less pain with the spray than without it. Another study demonstrated quick and effective pain relief for children during IV insertions. However, not all research agrees; one study found no significant benefit over a placebo for knee injections. Overall, current evidence suggests that vapocoolant spray can ease pain in various needle-related procedures. This trial will compare the effectiveness of the vapocoolant spray to a placebo, Nature's Tears, which does not provide analgesic effects. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals at least 14 years old who are undergoing Nexplanon implant insertion and can consent in English. It's not for those with prior vapocoolant spray exposure, needing sedation or anesthesia, having a removal and reinsertion in the same visit, or allergic to spray components.

Inclusion Criteria

Undergoing an etonogestrel implant insertion in the arm in POB1 Suite 1004 or POB2 Suite 402

English speaking

Able and willing to sign the informed consent form and agree to terms of the study

Exclusion Criteria

Known previous exposure to vapocoolant spray

Unable to provide written, informed consent in English

I need strong painkillers, anxiety medication, IV sedation, or general anesthesia for my procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive either Pain Ease vapocoolant spray or placebo spray just before lidocaine injection during Nexplanon insertion

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain and satisfaction immediately after the procedure

Immediately after procedure

What Are the Treatments Tested in This Trial?

Interventions

• Vapocoolant Spray

Trial Overview

The study tests if Pain Ease vapocoolant spray reduces pain from the lidocaine injection during Nexplanon insertion compared to a placebo. Participants will be randomly assigned to receive either the spray or placebo.

How Is the Trial Designed?

Group I: Vapocoolant Spray Experimental Treatment 1 Intervention

This is the study arm. Participants in this arm of the study will receive Pain Ease vapocoolant spray during their Nexplanon implant insertion in the arm. They will receive the spray on their arm right before lidocaine injection is administered for Nexplanon insertion procedure. Pain Ease vapocoolant spray is FDA approved for use on skin prior to common needle-stick procedures like intravenous (IV) starts and vaccines. The investigators will use the spray in a similar fashion, to help with the pain of lidocaine injection during Nexplanon insertion procedures. Physicians will do the Nexplanon procedure before any other procedures if patient has multiple procedures scheduled the same day.

Group II: Nature's Tears Placebo Group 1 Intervention

This is the placebo. This group will receive Nature's Tears, which is a saline spray that does not offer analgesic effects.

Who Is Running the Clinical Trial?

Queen's Medical Center

Lead Sponsor

Trials

24

Recruited

4,900+

Lakshmi Devi and Devraj Sharma Endowment

Collaborator

Trials

1

Recruited

100+

Published Research Related to This Trial

In a study of 300 adults, the use of vapocoolant spray significantly reduced pain during peripheral intravenous (PIV) cannulation compared to a placebo, with a median pain score of 2 for the vapocoolant group versus 4 for the placebo group (P<0.001).

The vapocoolant was well tolerated with minimal side effects, such as slight erythema in 2.7% of patients, which resolved quickly, and there were no significant changes in vital signs or visible skin abnormalities after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, double blind, randomized, controlled trial comparing vapocoolant spray versus placebo spray in adults undergoing intravenous cannulation. Mace, SE.[2019]

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 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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3267474/

The effect of vapocoolant spray on pain due to intravenous ...

The vapocoolant spray in our study quickly and effectively reduced pain due to intravenous cannulation in children and improved the success rate of cannulation.

2.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0279463

Efficacy and safety of vapocoolant spray for vascular puncture ...

Vapocoolant spray may relieve pain in adults received vein puncture and cannot cause severe side effects, but is ineffective in children.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0735675721006355

Evaluation of vapocoolant spray effect on pain reduction ...

Pain change during penetration was found to be significantly lower in the bilateral spray-treated group compared to the control group (p < 0.001). Pain change ...

4.

journals.lww.com

journals.lww.com/md-journal/fulltext/2025/02210/vapocoolant_spray_application_during.8.aspx

Vapocoolant spray application during intra-articular knee...

This study revealed that vapocoolant spray application had no significant advantage over placebo in terms of pain scores during intra-knee injection.

5.

annemergmed.com

annemergmed.com/article/S0196-0644(16)30256-6/pdf

Effect of Vapocoolant on Pain During Peripheral ...

The overall summary results based on meta-analysis found that vapo- coolants provide pain relief during cannulation (Table); however, pain increased slightly ...

6.

gebauer.com

gebauer.com/painease

Gebauer's Pain Ease Spray | Skin Refrigerant Anesthetic ...

It is non-drug, non-flammable, and can be used by any licensed healthcare practitioner without the order of a physician. What is a vapocoolant and how does it ...

7.

fda.gov

fda.gov/media/149645/download

NDP June 3, 2021 Presentation: Vapocoolant Devices-MLY

A vapocoolant device is a cold therapy device intended for the temporary relief and reduction of minor topical pain and swelling. The device ...

8.

cda-amc.ca

cda-amc.ca/sites/default/files/pdf/htis/aug-2011/RB0410_VapoCool_final.pdf

Topical Skin Refrigerant Sprays to Support Pain ...

All three studies found that non-ethyl chloride vapocoolant spray was safe and effective for reducing pain in adults3,5 and children7 undergoing.