Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?
This trial has been completed.
|Treatments||standard of care first, ph altered first|
|Sponsor||University of Arkansas|
|Collaborator||Howard J Barnhard, Resident Research Endowment.|
|Start date||August 2012|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT01660412, 31337|
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.
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Perceived Pain level
time frame: immediately after administration (<1 min)
Male or female participants at least 18 years old.
Inclusion Criteria: - Patients presenting for SLN imaging for melanoma or who have had an excisional biopsy for melanoma of the thorax and appendicular structures; - Patients scheduled to receive two or more injections of Tc-99m SC for the purpose of clinical management of melanoma or who have had an excisional biopsy for melanoma of the thorax and appendicular structures. Exclusion Criteria: - Patients presenting for SLN imaging of lesions involving the breast, ear, nose, and genitourinary regions; - Patients scheduled to receive only a single injection of Tc-99m SC; - Pregnant or breast feeding women.
|Official title||Does Alkalinization of Technetium-99m Sulfur Colloid Reduce Perceived Pain Levels During Non-breast Sentinel Lymphoscintigraphy?|
|Principal investigator||James A Ntambi, MD|
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