Pain
Conditions
Keywords
Pain, Alkalinization, Technetium 99m Sulfur Colloid, sentinel lymphoscintigraphy?
Brief 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.
Interventions
DRUGStandard 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.
DRUGph 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
Howard J Barnhard, Resident Research Endowment.
UAMS DEPT of Radiology.
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 122 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Pain Level | immediately after administration (<1 min) of each injection (up to total 5 minutes) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Each Participant received four injections. We tested four different injection sites. Each participant received all four injections at one site.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 3 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 13.6 |
| Region of Enrollment United States | 57 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 31 Participants |
| Weight | 159.9 lbs STANDARD_DEVIATION 46.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 11 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
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.
Time frame: immediately after administration (<1 min) of each injection (up to total 5 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Injection | Perceived Pain Level | 5.81 units on a scale | Standard Deviation 2.24 |
| PH Altered Injection | Perceived Pain Level | 4.39 units on a scale | Standard Deviation 2.45 |
p-value: <0.000195% CI: [0.85, 2]t-test, 2 sided