Trials / Recruiting
RecruitingNCT06933381
Vapocoolant Spray to Reduce Pain With Nexplanon Insertion
Topical Vapocoolant to Reduce Pain With Nexplanon Insertion: A Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- Sponsor
- Queen's Medical Center · Academic / Other
- Sex
- Female
- Age
- 14 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 | Placebo | Nature's Tears will be applied to the arm as a placebo spray |
Timeline
- Start date
- 2025-06-16
- Primary completion
- 2026-04-01
- Completion
- 2026-05-01
- First posted
- 2025-04-18
- Last updated
- 2026-01-09
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06933381. Inclusion in this directory is not an endorsement.