Trial Outcomes & Findings for Does Alkalinization Reduce Perceived Pain Levels During Sentinel Lymph Node Imaging? (NCT NCT01660412)

Last Updated: 2017-11-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

immediately after administration (<1 min) of each injection (up to total 5 minutes)

Results posted on

2017-11-20

Participant Flow

Each Participant received four injections. We tested four different injection sites. Each participant received all four injections at one site.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	29	31
Overall Study Head	1	4
Overall Study Thorax	9	9
Overall Study Appendicular Structures	17	11
Overall Study Other	2	4
Overall Study Injection 1	29	31
Overall Study Injection 2	29	31
Overall Study Injection 3	29	31
Overall Study Injection 4	29	31
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Protocol Violation	0	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=57 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.
Age, Continuous	57 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment United States	57 Participants n=5 Participants
Weight	159.9 lbs STANDARD_DEVIATION 46.1 • n=5 Participants

PRIMARY outcome

Timeframe: immediately after administration (<1 min) of each injection (up to total 5 minutes)

Outcome measures

Outcome measures
Measure	Standard of Care Injection n=57 Participants Approximately 1mc 99mTc-SC	PH Altered Injection n=57 Participants 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
Perceived Pain Level	5.81 units on a scale Standard Deviation 2.24	4.39 units on a scale Standard Deviation 2.45

Adverse Events

Standard of Care Injection

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

PH Altered Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard of Care Injection n=60 participants at risk Approximately 1mc 99mTc-SC	PH Altered Injection n=60 participants at risk 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
General disorders Injection Site Pain	18.3% 11/60 • Adverse events were monitored for each injection up to 5 minutes.	0.00% 0/60 • Adverse events were monitored for each injection up to 5 minutes.

Additional Information

James A Ntambi

UAMS

Phone: 5015265062

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place