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

University of Arkansas60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

Standard of Care First

ph Altered firstDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 122 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Perceived Pain Level

Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pain levels assessed after each injection were averaged for each participant.

Time frame: immediately after administration (<1 min) of each injection (up to total 5 minutes)