NCT01660412

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

Does Alkalinization of Technetium-99m Sulfur Colloid Reduce Perceived Pain Levels During Non-breast Sentinel Lymphoscintigraphy?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 122 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Standard of Care First	For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to \~7.40.
DRUG	ph Altered first	For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to \~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given.

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-12-30
• Completion: 2016-12-30
• First posted: 2012-08-08
• Last updated: 2017-11-20
• Results posted: 2017-11-20

Locations

1 site across 1 country: United States