drugset / Trial / NCT01660412

Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?

NCT01660412

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator sodium bicarbonate Diagnostic / imaging agent Other
Comparator Technetium-99m Sulfur Colloid Unknown Other

Indications

No indication recorded.