Vapocoolant Spray to Reduce Pain With Nexplanon Insertion
NCT ID: NCT06933381
Last Updated: 2026-01-09
Study Results
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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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-06-16
2026-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
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.
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.
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.
Placebo
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.
Placebo
Nature's Tears will be applied to the arm as a placebo spray
Other Intervention Names
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Eligibility Criteria
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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
* 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
14 Years
FEMALE
Yes
Sponsors
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Lakshmi Devi and Devraj Sharma Endowment
UNKNOWN
Queen's Medical Center
OTHER
Responsible Party
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Locations
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Queens Medical Center POB 2 Suite 402
Honolulu, Hawaii, United States
Queens Medical Center POB1 Clinic 1004
Honolulu, Hawaii, United States
Women's Center Queen's North Hawai'i Community Hospital Suite #124 and #120
Waimea, Hawaii, United States
Countries
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Central Contacts
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Facility Contacts
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Mary Tschann, PhD
Role: backup
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.
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.
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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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RA-2025-007
Identifier Type: -
Identifier Source: org_study_id
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