Clinical trial NCT06933381: Vapocoolant Spray to Reduce Pain With Nexplanon Insertion
Official title: Topical Vapocoolant to Reduce Pain With Nexplanon Insertion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Reducing Pain With Nexplanon Implant Insertion
Keywords: Vapocoolant spray
Pain with Nexplanon insertion
Contraceptive implant insertion
Vapocoolant
Lead sponsor: Queen's Medical Center
Sponsor class: OTHER
Collaborators: name: Lakshmi Devi and Devraj Sharma Endowment
First posted: 2025-04-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 in same visit
* 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

Primary outcomes:
measure: Pain with lidocaine injection
timeFrame: Immediately after lidocaine injection
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Immediately after procedure
measure: Pain Reduction with Remainder of Procedure
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Queens Medical Center POB1 Clinic 1004
state: Hawaii
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.