Clinical trial NCT01660412: Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?
Official title: Does Alkalinization of Technetium-99m Sulfur Colloid Reduce Perceived Pain Levels During Non-breast Sentinel Lymphoscintigraphy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain
Alkalinization
Technetium 99m Sulfur Colloid
sentinel lymphoscintigraphy?
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Howard J Barnhard, Resident Research Endowment.
name: UAMS DEPT of Radiology.
First posted: 2012-08-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 122
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Pain Level
timeFrame: immediately after administration (<1 min) of each injection (up to total 5 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UAMS
state: Arkansas
Study officials:
affiliation: UAMS
name: James A Ntambi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fetzer S, Holmes S. Relieving the pain of sentinel lymph node biopsy tracer injection. Clin J Oncol Nurs. 2008 Aug;12(4):668-70. doi: 10.1188/08.CJON.668-670.
citation: Stojadinovic A, Peoples GE, Jurgens JS, Howard RS, Schuyler B, Kwon KH, Henry LR, Shriver CD, Buckenmaier CC. Standard versus pH-adjusted and lidocaine supplemented radiocolloid for patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer (PASSION-P trial): a double-blind, randomised controlled trial. Lancet Oncol. 2009 Sep;10(9):849-54. doi: 10.1016/S1470-2045(09)70194-9. Epub 2009 Aug 5.
citation: Johnston MJ, Ntambi JA, Hilliard N, Spencer HJ, Vaughn R, Owens SS, Myrick RS, Parker LD, Garner DA, Yarbrough TL. Reducing perceived pain levels during nonbreast lymphoscintigraphy. Clin Nucl Med. 2015 Dec;40(12):945-9. doi: 10.1097/RLU.0000000000000905.