CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Standard of Care First +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01660412
NCT01660412N/ACompleted
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Does Alkalinization of Technetium-99m Sulfur Colloid Reduce Perceived Pain Levels During Non-breast Sentinel Lymphoscintigraphy?

University of Arkansas·interventional·Posted Aug 8, 2012·Updated Nov 20, 2017

In Brief

A clinical study evaluating Standard of Care First and ph Altered first for Pain. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
CollaboratorsHoward J Barnhard, Resident Research Endowment., UAMS DEPT of Radiology.

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 8, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 30, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 13.9 years ago

Interventions

Standard of Care Firstdrug

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.

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.