Vapocoolant Spray to Reduce Pain With Nexplanon Insertion

January 7, 2026 updated by: Queen's Medical Center

Topical Vapocoolant to Reduce Pain With Nexplanon Insertion: A Randomized Controlled Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queens Medical Center POB1 Clinic 1004
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sarah Murayama, MD
        • Principal Investigator:
          • Bliss Kaneshiro, MD MPH
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queens Medical Center POB 2 Suite 402
        • Contact:
        • Principal Investigator:
          • Sarah Murayama, MD
        • Contact:
          • Mary Tschann, PhD
          • Phone Number: 808-375-3785
        • Principal Investigator:
          • Bliss Kaneshiro, MD MPH
      • Waimea, Hawaii, United States, 96743
        • Not yet recruiting
        • Women's Center Queen's North Hawai'i Community Hospital Suite #124 and #120
        • Contact:
        • Principal Investigator:
          • Bliss Kaneshiro, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Other: Placebo
Nature's Tears will be applied to the arm as a placebo spray
Other Names:
  • Nature's Tears
Experimental: 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.
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 Names:
  • Pain Ease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain with lidocaine injection
Time Frame: Immediately after 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: Immediately after procedure
Patients will be asked about their satisfaction with pain control for the procedure and satisfaction for the procedure overall using a survey with 5 options, including very unsatisfied, unsatisfied, neutral, satisfied, and very satisfied.
Immediately after procedure
Pain Reduction with Remainder of Procedure
Time Frame: Immediately after the procedure
Participants will be asked to rate their pain using a visual analog scale (VAS) in regard to pain when the implant was inserted. 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.They will also be asked about their pain for the procedure overall using a Likert scale from 0 (no pain) to 10 (severe pain).
Immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's Medical Center

Collaborators

Lakshmi Devi and Devraj Sharma Endowment

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA-2025-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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