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NCT Number: NCT06933381

Vapocoolant Spray to Reduce Pain With Nexplanon Insertion

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

Recruiting

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Key information

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Queens Medical Center POB 2 Suite 402, Honolulu, Hawaii, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vapocoolant spray

Device

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

Placebo

Other

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

Other names: Nature's Tears

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Tschann, PhD

CONTACT

[email protected]

808-375-3785

Sarah Murayama, MD

CONTACT

[email protected]

808-783-0298

Sponsors and collaborators

Lead sponsor

Queen's Medical Center

Other

Collaborators

  • Lakshmi Devi and Devraj Sharma Endowment

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.