NCT06933381

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

March 31, 2025

Last Update Submit

January 7, 2026

Conditions

Reducing Pain With Nexplanon Implant Insertion

Keywords

Vapocoolant sprayPain with Nexplanon insertionContraceptive implant insertionVapocoolant

Outcome Measures

Primary Outcomes (1)

  • Pain with lidocaine injection

    The investigators will ask patients to rate their pain with lidocaine injection that precedes Nexplanon insertion using a visual analog scale (VAS). The visual analog scale is a 100 mm line, with values 0 to 100. 0 is marked as no pain and 100 is marked as worst pain.

    Immediately after lidocaine injection

Secondary Outcomes (2)

  • Patient satisfaction

    Immediately after procedure

  • Pain Reduction with Remainder of Procedure

    Immediately after the procedure

Study Arms (2)

Vapocoolant Spray

EXPERIMENTAL

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.

Device: Vapocoolant spray

Nature's Tears

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Vapocoolant sprayDEVICE

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

Also known as: Pain Ease
Vapocoolant Spray
PlaceboOTHER

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

Also known as: Nature's Tears
Nature's Tears

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Queens Medical Center POB 2 Suite 402

Honolulu, Hawaii, 96813, United States

RECRUITING

Queens Medical Center POB1 Clinic 1004

Honolulu, Hawaii, 96813, United States

RECRUITING

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

Waimea, Hawaii, 96743, United States

NOT YET RECRUITING

Related Publications (7)

  • 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: 8604867BACKGROUND

  • 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: 26979261BACKGROUND

  • 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: 30698458BACKGROUND

  • 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: 30253890BACKGROUND

  • 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: 26162573BACKGROUND

  • 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: 32123573BACKGROUND

  • 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: 33515699BACKGROUND

Related Links

Central Study Contacts

Sarah Murayama, MD

CONTACT

808-783-0298smura@hawaii.edu

Mary Tschann, PhD

CONTACT

808-375-3785mtschann@hawaii.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Research coordinators collecting pain scales from patients will also be blinded to intervention assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

April 18, 2025

Study Start

June 16, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)