N/A N=60 Randomized Quadruple-blind Treatment

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

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01660412 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2017

Primary outcome: Primary: Perceived Pain Level — 5.81; 4.39 units on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Standard of Care First (Drug); ph Altered first (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Arkansas
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Perceived Pain Level	5.81; 4.39	<0.0001 sig

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01660412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.