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| Name | Class |
|---|---|
| Howard J Barnhard, Resident Research Endowment. | UNKNOWN |
| UAMS DEPT of Radiology. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pH altered first | Active Comparator | The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered. |
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| Standard of Care first | Active Comparator | The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care First | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Pain Level | 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 pain levels assessed after each injection were averaged for each participant. | immediately after administration (<1 min) of each injection (up to total 5 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James A Ntambi, MD | UAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18676334 | Background | 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. | |
| 19664956 | Background | 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. |
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Each Participant received four injections. We tested four different injection sites. Each participant received all four injections at one site.
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| ID | Title | Description |
|---|---|---|
| FG000 | pH Altered First | The first injection administered will be the pH altered solution. The second injection will be the standard of care solution (opposite order). The remaining injections will be randomly assigned as either standard of care or pH altered. 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. |
| FG001 | Standard of Care First | The first injection administered will be the standard of care solution (SOC). The second injection will be the pH altered solution. The remaining injections will be randomly assigned as either standard of care or pH altered. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Subjects were randomized into 1 of 2 sequence groups (A and B): Sequence group A. The first injection administered was the standard-of-care (SOC) solution followed by the pH-altered solution. The remaining injections were randomly assigned as either SOC solution or pH-altered. Sequence group B. The first injection administered was the pHaltered solution followed by the SOC solution. The remaining injections were randomly assigned as either SOC solution or pH-altered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Perceived Pain Level | 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 pain levels assessed after each injection were averaged for each participant. | Posted | Mean | Standard Deviation | units on a scale | immediately after administration (<1 min) of each injection (up to total 5 minutes) |
|
Adverse events were monitored for each injection up to 5 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care Injection | Approximately 1mc 99mTc-SC | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | Systematic Assessment | Injection site pain of 8 of 10 or less was not considered an adverse event. Injection site pain of 9/10 or 10/10 was considered an adverse event. |
a sample size of 60 may be inadequate to generalize to all practices.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James A Ntambi | UAMS | 5015265062 | jantambi@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2012 | Nov 16, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| ph Altered first | Drug | 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. |
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| 26222533 | Result | 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | lbs |
|
| PH Altered Injection |
a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc |
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|
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| 60 |
| 0 |
| 60 |
| 11 |
| 60 |
| EG001 | PH Altered Injection | a diluted bicarbonate solution in a drop wise manner to raise the pH of the 99mTc-SC to a pH of 7.40 ± 0.05, dose Approximately 1mc | 0 | 60 | 0 | 60 | 0 | 60 |
|
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