Overview

This trial is active, not recruiting.

Condition pain
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 2017
Trial size 60 participants
Trial identifier NCT01660412, 31337

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered.
ph altered first Sodium Bicarbonate 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.
(Active Comparator)
The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered.
standard of care first Sodium Bicarbonate second
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.

Primary Outcomes

Measure
Perceived Pain level
time frame: immediately after administration (<1 min)

Eligibility Criteria

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.

Additional Information

Official title Does Alkalinization of Technetium-99m Sulfur Colloid Reduce Perceived Pain Levels During Non-breast Sentinel Lymphoscintigraphy?
Principal investigator James A Ntambi, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Arkansas.