Sound levels and safety in cosmetic laser surgery.

OBJECTIVES: Measure the sound levels produced by various lasers commonly used during routine outpatient cosmetic surgery to determine whether or not their use exceeds exposure levels set forth by the US National Institute for Occupational Safety and Health (NIOSH) and the US Occupational Safety and Health Administration (OSHA). MATERIALS AND METHODS: Using two different meters, the sound levels of lasers commonly used in cosmetic surgery were recorded during various procedures for several indications: tattoo removal, treatment of lentigines and pigmented lesions, facial erythema and vascular lesions, hair removal and resurfacing of acne scars, and photoaging. RESULTS: All but five lasers had a maximum sound level below 85 dBA, the limit proposed by NIOSH. The loudest laser examined was a fully ablative 2,940 nm Er:YAG during facial resurfacing, with an average maximum sound level of 101.5 decibels (dBA). Two other lasers used for resurfacing exceeded 85 dBA including a fractional ablative 1064 Nd:YAG with an average maximum of 97.8 and a different fully ablative 2,940 nm Er:YAG which had an average maximum of 96.3 nm. The two other lasers that exceeded 85 dBA were picosecond lasers used to treat black tattoos, including a 1,064 nm Nd:YAG with an average maximum of 93.7 dBA and a 755 nm alexandrite with an average maximum of 93.6 dBA. CONCLUSION: Although some lasers in cosmetic surgery may be perceived as being quite loud, they remain safe. Even the loudest laser studied would have to be used for nearly 2 hours before exceeding the OSHA recommended exposure limit. Even physicians who spend a large amount of time using lasers in clinical practice should be reassured that these devices are not likely to produce noise-induced hearing loss (NIHL) hearing loss. Lasers Surg. Med. 51:491-494, 2019. © 2019 Wiley Periodicals, Inc.

Setting appropriate pain expectations: Lessons learned from a clinical trial.

OBJECTIVE: This retrospective study compares subject-reported pain levels and expectations set forth by industry and treating physicians during a clinical trial of an energy based device. The physiologic and emotional aspects of pain expectations are discussed and recommendations are made for strategic patient counseling. MATERIALS AND METHODS: Average and mode pain scores were collected from the records of a previously conducted clinical trial investigating a radiofrequency microneedling device at three different settings. The trial protocol and device manual were reviewed to ascertain language regarding procedural pain. Treating physicians were asked how they learned about procedural pain and how they described it to subjects. Subject-reported pain scores and verbal pain descriptors from the device manual and trial protocol were translated onto validated pain scales, the Numerical Rating Scale (NRS), and the Verbal Rating Scale (VRS), for comparison. RESULTS: A total of 90 procedural pain scores were collected from 30 subject charts. The average procedural pain scores for three different device settings were 5.3, 6.7, and 4.6 out of 10 and the mode pain score was 6 out of 10. This translated to a 5-6 and 7-8 on the NRS, respectively and classification as "painful but bearable" and "considerable pain" on the VRS. Industry sourced pain levels translated to a 2-4 on the NRS and classification as "little pain" on the VRS. CONCLUSION: Subject-reported pain scores were higher than those set forth by industry materials and personnel. Physicians should be wary of manufacturer materials or anecdotal evidence that might mislead patients and cause undue physiological or emotional stress. Lasers Surg. Med. 9999:XX-XX, 2018. © 2018 Wiley Periodicals, Inc.

The perception of procedural vascular laser pain and discrepancies amongst patients, physicians, and industry.

BACKGROUND: The inherent subjectivity of pain perception makes pre-procedural pain counseling especially challenging. Setting the wrong pain expectations will negatively impact the patient's experience and affect their physiologic and emotional state. Best practices for sourcing pain related information about a given procedure, however, remains understudied. This retrospective study explores the accuracy of industry materials for describing procedural pain in a clinical trial when compared to subject reported pain scores from the same clinical trial. METHODS: Median and mode pain scores were collected from the data of a past clinical trial investigating a dual wavelength laser used for 4 different types of treatments. Industry provided materials were reviewed to ascertain language regarding procedural pain. The principal investigator was interviewed about setting pain expectations during the trial. Subject-reported pain scores and verbal pain descriptors were transferred to validated pain scales, the Numerical Rating Scale and the Verbal Rating Scale, for comparison. RESULTS: A total of 85 procedural pain scores were collected from 22 subject charts. The average procedural pain scores for 3 of 4 treatment types reported by subjects were translated to entirely different verbal and numerical categories of pain than that described by industry materials. CONCLUSIONS: Industry materials failed to capture the range of procedural pain scores reported by subjects for 3 of 4 treatment types in a clinical trial setting. When counseling patients on procedural pain, physicians should take extra care to not mislead patients and cause undue physiological or emotional stress.