Reducing Pain With Nexplanon Implant Insertion
Conditions
Keywords
Vapocoolant spray, Pain with Nexplanon insertion, Contraceptive implant insertion, Vapocoolant
Brief 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.
Interventions
DEVICEVapocoolant spray
Pain Ease will be used per manufacturer instruction, applying the spray for 5 seconds or until the skin turns white, whichever occurs first.
OTHERPlacebo
Nature's Tears will be applied to the arm as a placebo spray
Sponsors
Lakshmi Devi and Devraj Sharma Endowment
Queen's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Research coordinators collecting pain scales from patients will also be blinded to intervention assignment.
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain with lidocaine injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 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. |
| Pain Reduction with Remainder of Procedure | 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). |
Countries
United States
Contacts
Primary ContactSarah Murayama, MD
Backup ContactMary Tschann, PhD
Outcome results
None listed