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Randomized Controlled Trial
. 2024 Jul;31(7):4487-4497.
doi: 10.1245/s10434-024-15235-7. Epub 2024 Apr 1.

A Four-Arm Randomized Clinical Trial of Topical Pain Control for Sentinel Node Radiotracer Injections in Patients with Breast Cancer

Alyssa A Wiener  1 , Jessica R Schumacher  1 , Scott B Perlman  2 , Lee G Wilke  1 , Meeghan A Lautner  1 , Laura M Bozzuto  1 , Bret M Hanlon  3 , Heather B Neuman  4
Affiliations
Randomized Controlled Trial

A Four-Arm Randomized Clinical Trial of Topical Pain Control for Sentinel Node Radiotracer Injections in Patients with Breast Cancer

Alyssa A Wiener et al. Ann Surg Oncol. 2024 Jul.

Abstract

Background: Radioactive tracer injections for breast cancer sentinel lymph node mapping can be painful. In this randomized trial, we compared four approaches to topical pain control for radiotracer injections.

Methods: Breast cancer patients were randomized (9 April 2021-8 May 2022) to receive the institutional standard of ice prior to injection (n = 44), or one of three treatments: ice plus a vibrating distraction device (Buzzy®; n = 39), 4% lidocaine patch (n = 44), or 4% lidocaine patch plus ice plus Buzzy® (n = 40). Patients completed the Wong-Baker FACES® pain score (primary outcome) and a satisfaction with pain control received scale (secondary). Nuclear medicine technologists (n = 8) rated perceived pain control and ease of administration for each patient. At study conclusion, technologists rank-ordered treatments. Data were analyzed as intention-to-treat. Wilcoxon rank-sum tests were used to compare pain scores of control versus pooled treatment arms (primary) and then control to each treatment arm individually (secondary).

Results: There were no differences in pain scores between the control and treatment groups, both pooled and individually. Eighty-five percent of patients were 'satisfied/very satisfied' with treatment received, with no differences between groups. No differences in providers' perceptions of pain were observed, although providers perceived treatments involving Buzzy© more difficult to administer (p < 0.001). Providers rated lidocaine patch as the easiest, with ice being second.

Conclusion: In this randomized trial, no differences in patient-reported pain or satisfaction with treatment was observed between ice and other topical treatments. Providers found treatments using Buzzy® more difficult to administer. Given patient satisfaction and ease of administration, ice is a reasonable standard.

Keywords: Breast cancer; Pain; Randomized trial; Sentinel lymph node; Topical.

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Figures

Figure 1.
Figure 1.. Overview of Study Enrollment.
Figure 2.
Figure 2.. Wong-Baker FACES© Pain Scores for Control and Intervention Arms.
Median scores are indicated in red. Interquartile ranges are indicated by solid rectangles. Whiskers represent the upper and lower adjacent values. Dots represent outside values.
Figure 3.
Figure 3.. Easy of Use and Perceived Patient Pain Control for Treatment Arms as Rated by Nuclear Medicine Technologists.
See this image and copyright information in PMC

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