Vapocoolant Spray to Reduce Pain During Nexplanon Insertion
Topical Vapocoolant to Reduce Pain With Nexplanon Insertion: A Randomized Controlled Trial
This will test whether Pain Ease vapocoolant spray can reduce the pain of the lidocaine shot when getting a Nexplanon implant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 14 Years and up |
| Sex | Female |
| Sponsor | Queen's Medical Center Academic / other |
| Locations | 3 sites (Honolulu, Hawaii and 2 other locations) |
| Trial ID | NCT06933381 on ClinicalTrials.gov |
What this trial studies
People age 14 and older having an etonogestrel (Nexplanon) insertion at participating clinics will be screened for eligibility and invited to consent. Enrolled participants are randomized in a patient-blinded design to receive either Pain Ease vapocoolant spray or a saline placebo spray applied just before the lidocaine injection during the insertion procedure. The main outcome is pain reported during the lidocaine injection to determine whether the vapocoolant reduces injection discomfort compared with placebo. Procedures and follow-up occur at Queen's Medical Center clinics and affiliated Women's Center locations in Hawaii.
Who should consider this trial
Good fit: Ideal candidates are English-speaking people aged 14 or older scheduled for Nexplanon insertion at the participating Queen's Medical Center or affiliated clinics who can give written consent, do not require sedation or narcotics, and have no allergy to the spray ingredients.
Not a fit: Patients who need IV sedation or general anesthesia, who have contraindications to the vapocoolant components, who have prior vapocoolant exposure, or who cannot provide written consent in English are unlikely to benefit or be eligible for this intervention.
Why it matters
Potential benefit: If effective, the vapocoolant spray could make the local anesthetic injection for Nexplanon insertion noticeably less painful and improve patient comfort during the visit.
How similar studies have performed: Vapocoolant sprays have shown modest benefit in reducing injection or venipuncture pain in other clinical settings, but evidence specifically for contraceptive implant insertion is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Honolulu, Hawaii and 2 other locations
- Queens Medical Center POB 2 Suite 402 — Honolulu, Hawaii, United States (Recruiting)
- Queens Medical Center POB1 Clinic 1004 — Honolulu, Hawaii, United States (Recruiting)
- Women's Center Queen's North Hawai'i Community Hospital Suite #124 and #120 — Waimea, Hawaii, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Sarah Murayama, MD
- Email: smura@hawaii.edu
- Phone: 808-783-0298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.