Vapocoolant Spray to Reduce Pain With Nexplanon Insertion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vapocoolant spray, Placebo.
- Who it may be relevant to
- Registry conditions: Reducing Pain With Nexplanon Implant Insertion. Basic parameters: from 14 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Topical Vapocoolant to Reduce Pain With Nexplanon Insertion: A Randomized Controlled Trial
Overview
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
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.
Interventions
- Device 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. - Other Placebo
Nature's Tears will be applied to the arm as a placebo spray
Primary outcome measures
- Pain with lidocaine injection [Time frame: Immediately after lidocaine injection]
Secondary outcome measures (2)
- Patient satisfaction [Time frame: Immediately after procedure]
- Pain Reduction with Remainder of Procedure [Time frame: Immediately after the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- Queens Medical Center POB 2 Suite 402 — Honolulu
- Queens Medical Center POB1 Clinic 1004 — Honolulu
- Women's Center Queen's North Hawai'i Community Hospital Suite #124 and #120 — Waimea
Publications
- 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. PMID 8604867
- 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. PMID 26979261
- 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. PMID 30698458
- 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. PMID 30253890
- 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. PMID 26162573
- 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. PMID 32123573
- 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. PMID 33515699
Identifiers
NCT: NCT06933381 · RA-2025-007