drugset / Trial / NCT01660412
Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?
Completed
60 enrolled
University of Arkansas
Howard J Barnhard, Resident Research Endowment. · collabUAMS DEPT of Radiology. · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
Pain during nuclear medicine breast lymphnode detection procedures has been reported as high as 8.8/10. Using Sodium Bicarbonate to alkalinize the radio-pharmaceutical injection, pain can safely be reduced from 6.6/10 to 4.7/10, during breast lymph node detection procedures. In sites other then the breast, using Bicarbonate to make the injection's pH closer to natural, attempts to lower the pain levels will be performed. Hypothesis: The perceived pain level during non breast sentinel lymph node techniques can be reduced by raising the pH of the injectate (Tc-99m SC) to near the physiologic level of pH 7.40.
Timeline
- Start
- 2012-08-01
- Primary completion
- 2016-12-30
- Completion
- 2016-12-30
Publications
- Background Fetzer S, Holmes S. Relieving the pain of sentinel lymph node biopsy tracer injection. Clin J Oncol Nurs. 2008 Aug;12(4):668-70. doi: 10.1188/08.CJON.668-670.
- Background Stojadinovic A, Peoples GE, Jurgens JS, Howard RS, Schuyler B, Kwon KH, Henry LR, Shriver CD, Buckenmaier CC. Standard versus pH-adjusted and lidocaine supplemented radiocolloid for patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer (PASSION-P trial): a double-blind, randomised controlled trial. Lancet Oncol. 2009 Sep;10(9):849-54. doi: 10.1016/S1470-2045(09)70194-9. Epub 2009 Aug 5.
- Results Johnston MJ, Ntambi JA, Hilliard N, Spencer HJ, Vaughn R, Owens SS, Myrick RS, Parker LD, Garner DA, Yarbrough TL. Reducing perceived pain levels during nonbreast lymphoscintigraphy. Clin Nucl Med. 2015 Dec;40(12):945-9. doi: 10.1097/RLU.0000000000000905.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | sodium bicarbonate | Diagnostic / imaging agent | — | Other |
| Comparator | Technetium-99m Sulfur Colloid | Unknown | — | Other |
Indications
No indication recorded.