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Randomized Controlled Trial
. 2015 Dec:22 Suppl 3:S559-65.
doi: 10.1245/s10434-015-4802-y. Epub 2015 Aug 15.

Comparison of Post-injection Site Pain Between Technetium Sulfur Colloid and Technetium Tilmanocept in Breast Cancer Patients Undergoing Sentinel Lymph Node Biopsy

Jonathan T Unkart  1 , Jennifer L Baker  1 , Ava Hosseini  1 , Carl K Hoh  2 , Mark S Wallace  3 , David R Vera  2   4 , Anne M Wallace  5
Affiliations
Randomized Controlled Trial

Comparison of Post-injection Site Pain Between Technetium Sulfur Colloid and Technetium Tilmanocept in Breast Cancer Patients Undergoing Sentinel Lymph Node Biopsy

Jonathan T Unkart et al. Ann Surg Oncol. 2015 Dec.

Abstract

Background: No prior studies have examined injection pain associated with Technetium-99m Tilmanocept (TcTM).

Methods: This was a randomized, double-blinded study comparing postinjection site pain between filtered Technetium Sulfur Colloid (fTcSC) and TcTM in breast cancer lymphoscintigraphy. Pain was evaluated with a visual analogue scale (VAS) (0-100 mm) and the short-form McGill Pain Questionnaire (SF-MPQ). The primary endpoint was mean difference in VAS scores at 1-min postinjection between fTcSC and TcTM. Secondary endpoints included a comparison of SF-MPQ scores between the groups at 5 min postinjection and construction of a linear mixed effects model to evaluate the changes in pain during the 5-min postinjection period.

Results: Fifty-two patients underwent injection (27-fTcSC, 25-TcTM). At 1-min postinjection, patients who received fTcSC experienced a mean change in pain of 16.8 mm (standard deviation (SD) 19.5) compared with 0.2 mm (SD 7.3) in TcTM (p = 0.0002). At 5 min postinjection, the mean total score on the SF-MPQ was 2.8 (SD 3.0) for fTcSC versus 2.1 (SD 2.5) for TcTM (p = 0.36). In the mixed effects model, injection agent (p < 0.001), time (p < 0.001) and their interaction (p < 0.001) were associated with change in pain during the 5-min postinjection period. The model found fTcSC resulted in significantly more pain of 15.2 mm (p < 0.001), 11.3 mm (p = 0.001), and 7.5 mm (p = 0.013) at 1, 2, and 3 min postinjection, respectively.

Conclusions: Injection with fTcSC causes significantly more pain during the first 3 min postinjection compared with TcTM in women undergoing lymphoscintigraphy for breast cancer.

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Figures

Fig. 1
Fig. 1
Patient flow diagram. SLN sentinel lymph node; fTcSC filtered Technetium-99m Sulfur Colloid; TcTM Technetium-99m Tilmanocept
Fig. 2
Fig. 2
Baseline-corrected pain 1 min postinjection. This figure represents the pain difference for each individual 1-min after radiopharmaceutical injection
Fig. 3
Fig. 3
Linear mixed-effects model. fTcSC filtered Technetium-99m Sulfur Colloid; TcTM Technetium-99m Tilmanocept. This figure represents the final linear mixed-effects model that incorporates injection agent, time, injection × time interaction, baseline pain score, and needle localization on pain scores baseline-corrected during the first 5 min postinjection. The diamonds represent mean predicted pain scores for each injection agent with corresponding standard deviation
See this image and copyright information in PMC

References

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