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NCT01660412 · ClinicalTrials.gov registry record · NA
Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?
A NA study, sponsored by University of Arkansas.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01660412: Completed NA study, sponsored by University of Arkansas.
NCT01660412 is a NA study that has completed, run by University of Arkansas. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01660412, a NA study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pai
Interventions
- DRUG Standard of Care First
- DRUG ph Altered first
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-08-01 |
| Est. Completion | 2016-12-30 |
| Phase | NA |
What the finished NCT01660412 record still lists
NCT01660412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care First is the first listed.
NCT01660412 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01660412 about?
NCT01660412 is a clinical study titled "Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging?". 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...
What is the current status of trial NCT01660412?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2012-08-01. Estimated completion is 2016-12-30.
What interventions are being tested in trial NCT01660412?
The interventions under investigation include: Standard of Care First (DRUG), ph Altered first (DRUG).
Who is sponsoring clinical trial NCT01660412?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01660412's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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