Prospective, Single-arm, Split-face Pain Management Evaluation of Nitrous Oxide System During Micro-Focused Ultrasound With Visualization

November 2022 | Volume 21 | Issue 11 | 1228 | Copyright © November 2022


Published online October 31, 2022

doi:10.36849/JDD.7030

Jennifer VH Tran BSc, Shantel DJ Lultschik BHSc, Sheetal Sapra MD, Kevin Dong

Institute of Cosmetic and Laser Surgery, Oakville, ON

Abstract
Background: Although micro-focused ultrasound with visualization (MFU-V) has great cosmetic results, patients can be hesitant or decline the treatment due to the pain experienced during the treatment. The primary objective is to assess the efficacy of pain management of the nitrous oxide system during MFU-V treatment. The secondary objectives include patient satisfaction and efficacy on reducing facial laxity and improving aesthetic appearance.
Patients and Methods: A prospective, single-arm, split-face, open-label study. Ten patients were treated with MFU-V without use of a self-administered nitrous oxide system on the right side of the face, followed by use of the nitrous oxide system on the left. A patient-reported Visual Analog Pain Intensity Scale was used to assess pain on the right and left sides at 3 different treatment time points. Patient satisfaction was measured using a 5-point Likert scale and efficacy was measured using the Investigator GAIS and the Facial Laxity Score.
Results: Clinically significant differences were seen between pain ratings for the treated and untreated sides at 2 of the 3 time points. 100.0% of patients (n=9) who had completed the study were very satisfied (55.6%) or somewhat satisfied (44.4%). Five patients (55.6%) were scored as Improved on the GAIS and 4 patients (44.4%) were scored as Much Improved. 90.00% (n=9) of patients had moderate lower face and neck laxity prior to treatment, compared with 11.11% (n=1) and 22.22% (n=2) with moderate laxity at follow-up.
Conclusion: The nitrous oxide system provides clinically significant pain reduction, increases patient satisfaction, and improves cosmetic results of MFU-V treatment.

J Drugs Dermatol. 2022;21(11):1228-1234. doi:10.36849/JDD.7030

INTRODUCTION

There is a continuously increasing demand for non-invasive skin lifting and tightening procedures.1 One such procedure is micro-focused ultrasound with visualization (MFU-V), which uses low ultrasound energy to elevate the temperature of the dermal and subdermal layers of the skin.1 This causes both collagen contraction and formation, resulting in lifting and tightening of sagging skin.1 The most commonly reported adverse event associated with this treatment is procedural discomfort and pain.1 One study reported pain scores of 5.68, 6.09, and 6.53 for the cheek, submental, and submandibular regions, respectively, based on a visual analog scale from 0 (no pain) to 10 (maximal pain).2 One of the suggested methods to decrease treatment discomfort is the use of oral acetaminophen.1 One practice reports that most patients receive a combination of topical anesthesia, oral diazepam, and an intramuscular injection of meperidine and hydroxyzine4; however, it is important to offer pain management that is both effective and does not have lasting effects following treatment.

The use of an analgesic is useful in cosmetic procedures to help patients feel more comfortable, increasing patient satisfaction. One proposed treatment is nitrous oxide, which can be administered as a system of a fixed 50%-50% nitrous oxide and oxygen mixture.5 There are many benefits of using nitrous oxide for pain management. It has a rapid onset due to its low solubility in the blood, as well as rapid clearance through the lungs.5 This means patients are able to drive immediately following the procedure and return to daily activities immediately, unlike with narcotics and other controlled substances.6-7 Additionally, nitrous oxide is a safe treatment, with the most frequent adverse event being nausea and vomiting.5 More serious events are only seen with high exposure or abuse.5

The primary objective of this study is to evaluate the efficacy of the nitrous oxide system in reducing pain experienced by patients during treatment with MFU-V treatment. The secondary objectives include safety of MFU-V treatment with the nitrous oxide system, patient satisfaction with MFU-V treatment