Comparison of Post-injection Site Pain Between Technetium Sulfur Colloid and Technetium Tilmanocept in Breast Cancer Patients Undergoing Sentinel Lymph Node Biopsy.
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.
Department of Surgery, University of California, San Diego, La Jolla, CA, 92093, USA.
Jonathan T
JT
Unkart
Department of Surgery, University of California, San Diego, La Jolla, CA, 92093, USA.
Jennifer L
JL
Baker
Department of Surgery, University of California, San Diego, La Jolla, CA, 92093, USA.
Ava
A
Hosseini
Department of Radiology, University of California, San Diego, La Jolla, CA, USA.
Carl K
CK
Hoh
Department of Anesthesia, University of California, San Diego, La Jolla, CA, USA.
Mark S
MS
Wallace
Department of Radiology, University of California, San Diego, La Jolla, CA, USA.|Molecular Imaging Program, University of California, San Diego, La Jolla, CA, USA.
David R
DR
Vera
Department of Surgery, University of California, San Diego, La Jolla, CA, 92093, USA. amwallace@ucsd.edu.
Anne M
AM
Wallace
D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000601:surgery; D003911:Dextrans / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008198:Lymph Nodes / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D061305:Lymphoscintigraphy / Q000009:adverse effects*; D008351:Mannans / Q000009:adverse effects*; D008875:Middle Aged; D009367:Neoplasm Staging; D010146:Pain / Q000175:diagnosis* / Q000209:etiology; D011379:Prognosis; D019275:Radiopharmaceuticals / Q000009:adverse effects; D021701:Sentinel Lymph Node Biopsy / Q000009:adverse effects*; D016284:Technetium Tc 99m Pentetate / Q000009:adverse effects / Q000031:analogs & derivatives*; D013671:Technetium Tc 99m Sulfur Colloid / Q000009:adverse effects*
D003911:Dextrans; D008351:Mannans; D019275:Radiopharmaceuticals; C431884:technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran; D013671:Technetium Tc 99m Sulfur Colloid; D016284:Technetium Tc 99m Pentetate