Vapocoolant spray
DevicePain 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
NCT Number: NCT06933381
The purpose of this study is to assess if Pain Ease vapocoolant spray decreases pain associated with lidocaine injection during Nexplanon insertion procedures.
Interested in participating?
Request Info14 year and older
Female
Interventional
Not applicable
Queens Medical Center POB 2 Suite 402, Honolulu, Hawaii, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Nature's Tears will be applied to the arm as a placebo spray
Other names: Nature's Tears
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.
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.
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).
Contact information is provided by the study sponsor or research team.
Mary Tschann, PhD
CONTACT
Sarah Murayama, MD
CONTACT
Queen's Medical Center
Other
Topical Vapocoolant to Reduce Pain With Nexplanon Insertion: A Randomized Controlled Trial
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.