MedTrace Logo

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

NCT01660412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-11-20

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Standard of Care First

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.

DRUG

ph Altered 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.

Sponsors & Collaborators

  • Howard J Barnhard, Resident Research Endowment.

    collaborator UNKNOWN

  • UAMS DEPT of Radiology.

    collaborator UNKNOWN

  • University of Arkansas

    lead OTHER

Principal Investigators

  • James A Ntambi, MD · UAMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
122 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-01
Primary Completion
2016-12-30
Completion
2016-12-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01660412 on ClinicalTrials.gov