Vapocoolant Spray to Reduce Pain With Nexplanon Insertion

Queen's Medical Center

Status: Enrolling

Conditions: Reducing Pain With Nexplanon Implant Insertion

Treatments: Other: Placebo; Device: Vapocoolant spray

Study type: Interventional

Funder types: Other

Identifiers

NCT06933381

RA-2025-007

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups, including a placebo group

Vapocoolant Spray

Experimental group

Description:

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.

Treatment:

Device: Vapocoolant spray

Nature's Tears

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo