Vapocoolant Spray for Pain Relief

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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess if Pain Ease vapocoolant spray decreases pain associated with lidocaine injection during Nexplanon insertion 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 data supports the effectiveness of the treatment Vapocoolant Spray for pain relief?

Research shows that vapocoolant spray effectively reduces pain during procedures like blood donation and intravenous cannulation. In one study, young male donors reported significantly lower pain scores when the spray was used compared to no treatment. ^{1 2 3 4 5}

How does vapocoolant spray differ from other treatments for pain relief?

Vapocoolant spray is unique because it provides rapid pain relief through skin cooling without the need for needles or long waiting times, unlike traditional local anesthetics. It is easy to apply, acts almost instantly, and is cost-effective, making it a convenient option for reducing pain during minor procedures like injections or blood draws. ^{2 3 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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.

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+

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 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 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]

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]

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

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

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

Topical Vapocoolant-Associated Vaso-occlusive Event in a 10-year-old with Sickle Cell Disease. [2022]

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

Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture. [2016]

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

The effect of using vapocoolant spray for pain reduction in arteriovenous fistula cannulation among patients undergoing hemodialysis: A randomized control trial. [2023]

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

Microcirculatory effect of topical vapocoolants. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

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