Vapocoolant Spray to Reduce Pain With Nexplanon Insertion

NCT ID: NCT06933381

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-16

Study Completion Date

2026-05-01

Brief Summary

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The purpose of this study is to assess if Pain Ease vapocoolant spray decreases pain associated with lidocaine injection during Nexplanon insertion procedures.

Detailed Description

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This study will be for patients in the office having a Nexplanon (etonogestrel implant) insertion. The doctor in clinic will evaluate if a patient meets eligibility criteria for this study. If the patient meets eligibility criteria, the doctor will inform the patient of the study and the potential risks. If patients elect to participate, a research coordinator will obtain written informed consent. The patient will be randomized (patient is blinded) to receive either Pain Ease vapocoolant spray or placebo (normal saline) spray. They will receive the spray just before lidocaine injection during the Nexplanon insertion procedure. The purpose of the study is to see if Pain Ease vapocoolant spray reduces patient pain during lidocaine injection for Nexplanon insertion.

Conditions

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Reducing Pain With Nexplanon Implant Insertion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Research coordinators collecting pain scales from patients will also be blinded to intervention assignment.

Study Groups

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Vapocoolant Spray

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 Type EXPERIMENTAL

Vapocoolant spray

Intervention Type DEVICE

Pain Ease will be used per manufacturer instruction, applying the spray for 5 seconds or until the skin turns white, whichever occurs first.

Nature's Tears

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Nature's Tears will be applied to the arm as a placebo spray

Interventions

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Vapocoolant spray

Pain Ease will be used per manufacturer instruction, applying the spray for 5 seconds or until the skin turns white, whichever occurs first.

Intervention Type DEVICE

Placebo

Nature's Tears will be applied to the arm as a placebo spray

Intervention Type OTHER

Other Intervention Names

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Pain Ease Nature's Tears

Eligibility Criteria

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Inclusion Criteria

* At least 14 years or older
* 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

* Required or requested narcotics, anxiolytics, IV sedation, or general anesthesia for the procedure
* Known previous exposure to vapocoolant spray
* Nexplanon removal and reinsertion same day during visit in the same arm
* Contraindications to vapocoolant spray components (ethyl chloride and 1,1,1,3,3-pentafluoropropane/1,1,1,2-tetrafluroethane)
* Unable to provide written, informed consent in English
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lakshmi Devi and Devraj Sharma Endowment

UNKNOWN

Sponsor Role collaborator

Queen's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Queens Medical Center POB 2 Suite 402

Honolulu, Hawaii, United States

Site Status RECRUITING

Queens Medical Center POB1 Clinic 1004

Honolulu, Hawaii, United States

Site Status RECRUITING

Women's Center Queen's North Hawai'i Community Hospital Suite #124 and #120

Waimea, Hawaii, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Sarah Murayama, MD

Role: CONTACT

808-783-0298

Mary Tschann, PhD

Role: CONTACT

808-375-3785

Facility Contacts

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Sarah Murayama, MD

Role: primary

808-783-0298

Mary Tschann, PhD

Role: backup

808-375-3785

Sarah Murayama, MD

Role: primary

808-783-0298

Mary Tschann, PhD

Role: backup

808-375-3785

Bliss Kaneshiro, MD, MPH

Role: primary

808-372-7560

References

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Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.

Reference Type BACKGROUND
PMID: 8604867 (View on PubMed)

Mace SE. Prospective, randomized, double-blind controlled trial comparing vapocoolant spray vs placebo spray in adults undergoing venipuncture. Am J Emerg Med. 2016 May;34(5):798-804. doi: 10.1016/j.ajem.2016.01.002. Epub 2016 Jan 7.

Reference Type BACKGROUND
PMID: 26979261 (View on PubMed)

Unal N, Tosun B, Aslan O, Tunay S. Effects of Vapocoolant Spray Prior to SC LMWH Injection: An Experimental Study. Clin Nurs Res. 2021 Feb;30(2):127-134. doi: 10.1177/1054773818825486. Epub 2019 Jan 30.

Reference Type BACKGROUND
PMID: 30698458 (View on PubMed)

Zhu Y, Peng X, Wang S, Chen W, Liu C, Guo B, Zhao L, Gao Y, Wang K, Lou F. Vapocoolant spray versus placebo spray/no treatment for reducing pain from intravenous cannulation: A meta-analysis of randomized controlled trials. Am J Emerg Med. 2018 Nov;36(11):2085-2092. doi: 10.1016/j.ajem.2018.03.068. Epub 2018 Mar 27.

Reference Type BACKGROUND
PMID: 30253890 (View on PubMed)

Collado-Mesa F, Net JM, Arheart K, Klevos GA, Yepes MM. Application of a topical vapocoolant spray decreases pain at the site of initial intradermal anaesthetic injection during ultrasound-guided breast needle biopsy. Clin Radiol. 2015 Sep;70(9):938-42. doi: 10.1016/j.crad.2015.04.013. Epub 2015 Jul 7.

Reference Type BACKGROUND
PMID: 26162573 (View on PubMed)

Wilson GA, Jeter JW, Dabbs WS, Stevens AB, Heidel RE, Chamberlin SM. Comparison of traditional anesthesia method and jet injector anesthesia method (MadaJet XL(R)) for Nexplanon(R) insertion and removal. Contracept Reprod Med. 2020 Feb 24;5:1. doi: 10.1186/s40834-020-00104-x. eCollection 2020.

Reference Type BACKGROUND
PMID: 32123573 (View on PubMed)

Bentsianov SD, Brandi K, Chen P, Shimoni N. A Pilot Study to Understand the Adolescent Pain Experience During Contraceptive Implant Insertion. J Pediatr Adolesc Gynecol. 2021 Aug;34(4):522-524. doi: 10.1016/j.jpag.2021.01.013. Epub 2021 Jan 27.

Reference Type BACKGROUND
PMID: 33515699 (View on PubMed)

Other Identifiers

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RA-2025-007

Identifier Type: -

Identifier Source: org_study_id

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