This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Lidocaine Administration Using STAR Particles (NCT06034340), a na na study. The primary outcome is Percent of Sharp (as Opposed to Dull) Sensation Over Application Area.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06034340 |
| Phase | NA |
| Condition | Anesthesia, Local |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Emory University |
| Results posted | Yes |
2. Clinical Question
The study asks whether applying STAR particles before lidocaine-epinephrine-tetracaine (LET) gel is associated with a different sensation of sharpness than applying aloe gel before LET gel. The endpoint is intended to reflect how quickly local anesthesia develops: participants reported the area that still felt sharp, rather than dull, after the gel was applied.
Population
The record describes children, adolescents, and young adults. All 22 participants had STAR particles applied before LET gel on one arm and aloe gel before LET gel on the opposite arm.
Intervention
LET gel was applied after STAR particle application on either the right or left arm. The record describes the particles as tiny ceramic pieces with small spikes.
Comparator
The opposite arm received aloe gel before LET gel, without STAR particle application. The record identifies this as the control method.
Primary question
What percentage of the application area was reported as sharp, rather than dull, at 10 minutes or 20 minutes after LET gel application, following each pretreatment method?
This setup compares methods applied to different arms of the same participant, rather than assigning participants to separate treatment groups. The registry lists allocation as NA and explicitly cautions that this is not a randomized, like-for-like control comparison. The arm-level sensation results and any estimated difference between methods are not reported in the registry record. Consequently, the clinical question is stated, but the posted results do not establish how sharpness differed between the two methods.
3. Trial Design
This completed study, NCT06034340, is titled “Lidocaine Administration Using STAR Particles.” Emory University is listed as the sponsor. The recorded start date is 2023-03-19, and the primary completion date is 2023-06-13. The study enrolled 22 participants and is listed as a single-group study with phase NA.
Each participant received both pretreatment methods on different arms. STAR particles were applied before LET gel on one arm; aloe gel was applied before LET gel on the opposite arm. The STAR-treated arm could be the right or left arm. The registry lists the masking status as NONE and allocation as NA. It does not report random assignment of the method to an arm, or a masking procedure. It also cautions that the arms are not a like-for-like randomized control comparison.
The primary outcome concerns the participant-reported percentage of the application area with sharp, rather than dull, sensation. The stated assessment time was Day 1 at 10 minutes or 20 minutes after LET gel application. The record says that half of the participants were assessed at 10 minutes and the other half at 20 minutes. It does not report whether the time assignment was randomized, or how the outcome was analyzed across assessment times.
The record lists secondary outcomes concerning change in transepidermal water loss, acute skin reactions, adverse events, and serious adverse events. No outcome analysis estimates are reported in the registry record. Thus, the design and intended measurements can be described, but the available results do not show the primary outcome values or comparisons.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: All participants received local anesthesia with LET gel via different methods on different arms. One arm had STAR particles applied before LET gel and the other had aloe gel (the control condition) applied before LET gel. Assessments for sharp sensation and pain took place at 10 minutes for half (11) of the participants and at 20 minutes for the other half (11) of the participants.
Overall Study
| Stage | LET Gel After STAR Particle Application (Right or Left Arm) | LET Gel Application Without STAR Particle Application (Contralateral Arm) |
|---|---|---|
| STARTED | 22 | 22 |
| 10 Minutes After LET Gel Application | 11 | 11 |
| 20 Minutes After LET Gel Application | 11 | 11 |
| COMPLETED | 22 | 22 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All 22 participants had STARS applied before the LET gel on either arm and Aloe (Control) gel was applied before the LET gel on the opposite arm. Half of the participants were assessed for sharp sensation at 10 minutes and the other half were evaluated 20 minutes after the application of LET gel in both participants' arms (STAR particle and aloe (Control) gel pretreatment).
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All participants received local anesthesia with LET gel via different methods on different arms. One arm had STAR particles applied before LET gel and the opposite one had aloe gel (the control condition) applied before LET gel.
| Characteristic | Unit | ALL PARTICIPANTS |
|---|---|---|
| Participants analysed | 22 | |
| Age, Continuous | years | 13.36 (SD 1.72) |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 16 |
| Race/Ethnicity, Customized: White | Participants | 19 |
| Race/Ethnicity, Customized: Mixed (Black/White) | Participants | 2 |
| Race/Ethnicity, Customized: Mixed (Pacific Islander/White) | Participants | 1 |
| Region of Enrollment: United States | participants | 22 |
| Weight | kilograms (kg) | 50.3 (SD 13.4) |
| Height | centimeters (cm) | 156.7 (SD 12.4) |
| Body Mass Index (BMI) | kg/m^2 | 20.2 (SD 3.8) |
| Body Surface Area (BSA) | square meters (m^2) | 1.47 (SD 0.24) |
6. Primary Endpoint
The registry lists the primary outcome as Percent of Sharp (as Opposed to Dull) Sensation Over Application Area, measured over Day 1 at 10 minutes or 20 minutes after application of LET gel.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | Percentage of area with sharp sensation |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the percent of the application area reported as having a sharp sensation, as opposed to a dull sensation. It is assessed at 10 minutes or 20 minutes after LET gel application on Day 1. The measure is described as a mean, with standard error as its dispersion measure.
This endpoint was selected to capture a participant’s sensation in the treated area. In general, the distinction between sharp and dull sensation can serve as a measure of perceived numbing: the endpoint records the extent of sharp sensation rather than directly measuring a clinical event or the concentration of anesthetic. The study’s stated purpose is to assess the time to achieve anesthesia by asking participants about sensation at the specified assessment time.
The interpretation depends on the actual values for each arm and how they compare. Those values, along with any estimated contrast, are not reported in the registry record. The record therefore identifies what was measured but does not show whether reported sharp sensation differed after STAR particle application versus aloe gel application. It also does not report results separately by assessment time, or explain how observations from the two assessment times were combined, if they were combined.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a primary outcome but does not report its observed values. It gives no mean percentage of sharp sensation for either arm and no estimated contrast between STAR particle pretreatment and aloe gel pretreatment. The posted results therefore do not establish the direction or size of any difference in the primary endpoint. There is also no reported confidence interval or hypothesis-test result for that comparison.
The study’s within-participant structure is important for interpretation. Each participant received both methods, one on each arm, so the observations are linked within a participant rather than arising from separate groups of people. In general, an analysis can account for such pairing, but the statistical approach used for the primary endpoint is not reported in the registry record. The record also cautions that this was not a randomized comparison and that the arms are not a like-for-like control comparison. The method for choosing which arm received STAR particles is not reported.
The timing of assessment also matters. The record states that participants were assessed at either 10 minutes or 20 minutes after gel application. It does not report arm-specific results by time, whether the timing assignment was randomized, or the analysis used to account for assessment time. Without these details and the outcome estimates, the posted information cannot show whether the sensation endpoint differed at either assessment time.
The record reports 22 participants and provides safety counts for each arm. For both arms, it reports 0 participants with serious adverse events and 0 with other adverse events, with 22 at risk for each category in each arm. It also reports 0 deaths in each arm. These are descriptive safety counts; they do not supply the missing primary efficacy estimates, nor do they establish that uncommon events could be ruled out.
In general, a confidence interval communicates the range of values compatible with an estimate under the analysis assumptions, and a hypothesis test assesses evidence against a specified null hypothesis. Neither an estimate nor such inferential results are reported for the primary endpoint. As a result, precision and statistical evidence for a difference cannot be assessed from the registry record. The appropriate reading is that the trial record describes an intended comparison and some safety counts, while its posted results do not answer the primary sensation question.
9. Statistical Methods Explained
The record characterizes the primary measure as a mean of a continuous outcome, with standard error as the dispersion measure. It does not report the numeric means, standard errors, confidence intervals, test statistics, p-values, or an analysis method for the primary endpoint. The explanations below describe general statistical ideas; they do not identify methods used in this trial unless the registry record states them.
What does the mean represent?
In general, a mean is an average across measured observations. For this endpoint, each observation concerns the percentage of the application area that a participant reports as sharp rather than dull. An arm-level mean would describe the average reported sharp-sensation percentage for that arm in the analyzed participants. The registry record does not post either arm-level mean, so no value or direction of difference can be interpreted.
A mean can provide a compact summary, but it does not reveal how individual participants’ reports were distributed. Participants may have similar values or widely varying values even when an average is the same. The record does not report individual observations, a distribution summary beyond the stated standard error, or a plot of the participant-level outcome.
What does standard error describe?
In general, standard error describes the precision of an estimated mean: smaller standard errors indicate less sampling uncertainty in that mean, while larger standard errors indicate more. It is not the same quantity as the spread of individual observations. Standard deviation is commonly used to describe that participant-to-participant spread. The record specifies standard error for the primary measure, but does not report a numerical standard error or a standard deviation.
A standard error alone would not describe the uncertainty in the difference between arms. That comparison requires an estimate of the contrast and a method that reflects how the paired arm observations relate to one another. No such contrast or uncertainty estimate is reported in the registry record.
Why does the paired structure matter?
In general, measurements from the same participant tend to be related. An analysis that respects this pairing can compare the two arm measurements within each participant rather than treating every arm measurement as independent. The registry describes both pretreatment methods being used on different arms of each participant, but it does not report whether the primary analysis used paired methods. No model, test, or variance calculation is described.
The record also flags that this is not a randomized comparison and that the arms are not a like-for-like control comparison. In general, random assignment can help balance systematic differences between treatment conditions, while a within-participant design can control for characteristics shared by the participant. Neither feature removes all possible sources of bias. The registry does not report how arm side was chosen, whether order or application procedures were standardized, or whether the outcome assessor was masked.
Why could over-dispersion matter?
In general, over-dispersion means that observed variation is greater than an analysis model expects. It can make standard errors too small and statistical evidence appear more precise than warranted if the analysis does not account for the extra variation. This concept can matter for outcomes whose variability differs from the assumptions of a chosen model. The registry record does not identify a model for the continuous sensation endpoint, report a dispersion check, or state that over-dispersion was assessed. It is therefore not possible to say whether this issue arose or how it was handled.
What can a confidence interval add?
In general, a confidence interval accompanies an estimate and expresses its statistical uncertainty under the method’s assumptions. A narrow interval indicates greater precision than a wide interval, but the interval does not by itself establish clinical importance. For this trial, neither a confidence interval for an arm mean nor one for the between-method contrast is reported in the registry record. The precision of the primary result is therefore unknown.
What do planning calculations mean?
In general, sample-size planning calculations describe the number of participants per arm associated with specified assumptions about a future or hypothetical study. They are not a measure of the probability that a completed study detected an effect. The registry’s stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and fractions of the observed effect. It is described as an illustration computed from the observed effect, not as the trial’s own design. Any values in such an illustration should be read as planning quantities, not observed power. The registry record does not report a trial-specific sample-size justification or the assumptions used to plan enrollment.
The record does not report an interim analysis, a prespecified statistical analysis plan, or the procedures used to handle repeated or missing observations. Those methods should not be inferred from the endpoint description or from the study’s single-group classification.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures overall, including the primary sensation measure and secondary outcomes concerning transepidermal water loss, acute skin reactions, adverse events, and serious adverse events. The record does not report a multiplicity strategy. In general, when several outcomes or comparisons are evaluated, the chance of at least one apparently notable result can increase; prespecified priorities or adjustment procedures can help explain how such results should be interpreted. No such procedure is reported, and no inferential outcome results are posted.
The record does not report a missing-data policy, the number of missing primary outcome observations, or how incomplete measurements were handled. It states that all 22 participants had both pretreatment methods applied, and that participants were assessed at 10 minutes or 20 minutes. That description does not establish whether every planned sensation response was recorded or analyzed. The effect of missingness on the primary result therefore cannot be assessed.
The description identifies the participants who received the two methods, but the analysis population and any exclusions from analysis are not reported in the registry record. The approach to participants with incomplete or unusable observations is also not reported. In general, analysis-population definitions matter because results can depend on which participants and measurements are included. With no posted endpoint estimates or missing-data accounting, the extent to which the analyzed data represent all enrolled participants remains unclear.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| LET Gel After STAR Particle Application (Right or Left Arm) | 0 | 22 | 0.0% |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | 0 | 22 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| LET Gel After STAR Particle Application (Right or Left Arm) | 0 of 22 |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | 0 of 22 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| LET Gel After STAR Particle Application (Right or Left Arm) | 0 of 22 |
| LET Gel Application Without STAR Particle Application (Contralateral Arm) | 0 of 22 |
The registry reports safety counts separately for LET gel after STAR particle application and LET gel without STAR particle application on the contralateral arm. In each arm, 22 participants are listed as at risk for serious adverse events, and 0 participants are listed as affected. For other adverse events, each arm likewise has 22 at risk and 0 affected. Deaths are reported as 0 in each arm, and no serious adverse event terms are listed.
These figures are participant counts, not a detailed account of event types, timing, severity, or duration. The record does not report further information about safety surveillance or whether every participant completed all safety assessments. The zero counts should therefore be read as the posted registry counts, not as proof that an event was impossible or that uncommon harms have been ruled out. They also do not establish comparative safety: the study was not described as a randomized, like-for-like control comparison, and the record reports no statistical safety comparison.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study enrolled 22 participants and used both pretreatment methods on different arms of each participant. Its primary question concerns the percentage of the application area reported as sharp rather than dull after LET gel application. The record also reports the assessment timing and safety counts. These registry entries describe the study’s intended measurement and its posted safety summary.
The record does not report the primary sensation values for either arm, an estimated contrast, or an uncertainty interval. It therefore does not show whether sharp sensation was higher or lower after either pretreatment method, or how large any difference might have been. No conclusion about the primary endpoint’s statistical precision can be drawn from the posted results.
In general, an observed difference in a sensation measure would not alone establish why the difference occurred. Interpretation would depend on the study design, analysis, outcome measurement, and uncertainty. Here, the registry explicitly cautions that the comparison was not randomized and that the arms are not a like-for-like control comparison. The method for assigning STAR particles to the right or left arm and the statistical approach to the paired observations are not reported.
The safety counts show 0 participants with reported serious adverse events and 0 with other adverse events in each arm, with 0 deaths reported in each arm. Those counts are limited to what appears in the registry and do not establish the absence of all possible adverse events. The record also does not report detailed event descriptions or the completeness of safety follow-up.
Accordingly, the posted information is descriptive rather than sufficient to establish an effect on the primary sensation outcome. It documents the comparison the investigators set out to make, but the registry record does not report the outcome estimates needed to answer that question.
13. Why This Trial Matters Statistically
This study illustrates why the design structure and the reported analysis both matter. Each participant received STAR particle pretreatment on one arm and aloe gel pretreatment on the opposite arm. In general, such a within-participant setup creates linked observations, so the analysis should reflect the relationship between measurements from the same person. The registry record does not state whether the primary analysis did so.
The record also explicitly cautions against treating the arms as a randomized, like-for-like comparison. This is a statistical interpretation issue, not just a label: differences between conditions can be difficult to attribute to the pretreatment when allocation and other design details are not reported. The stated outcome may be relevant to the study question, but conclusions also depend on transparent reporting of the comparison method and its uncertainty.
Reporting the mean and its standard error would help readers understand the arm-level outcome and its precision. Reporting a contrast with an uncertainty interval would make the comparison more directly interpretable. Neither arm-level sensation estimates nor a contrast is reported in the registry record. The posted safety counts are informative as counts, but they cannot substitute for the primary outcome analysis.
The study also shows the importance of distinguishing a completed trial from a fully reported result. Its status is COMPLETED, yet the primary endpoint results and analysis methods are not reported in the registry record. Readers can identify the question, design, and reported safety counts, but cannot determine the magnitude or precision of any difference in sharp sensation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation for interpreting the registry results is that the primary endpoint estimates are not reported. The record names the measure and assessment times but gives no arm-level means, contrast, confidence interval, or test result. Thus, neither the direction nor the magnitude or precision of the primary outcome comparison can be evaluated.
The record describes treatment on opposite arms within each participant but cautions that the comparison was not randomized and that the arms are not a like-for-like control comparison. It does not report how the STAR-treated side was selected or whether application order was controlled. The statistical handling of the within-participant measurements is also not reported. These omissions limit assessment of possible allocation, procedural, and analysis-related biases.
Participants were assessed at either 10 minutes or 20 minutes, but the record does not report whether results were separated by assessment time or how time was incorporated into an analysis. It also does not report whether timing assignment was randomized. The primary population description indicates that all 22 participants received both methods, but it does not establish that all sensation observations were complete or included in an analysis. Missing-data handling and analysis-population definitions are not reported in the registry record.
Masking is listed as NONE. The record does not describe additional safeguards for outcome assessment. The primary endpoint is participant-reported sensation, so the absence of masking is relevant when considering how responses were collected, although the record does not provide information to quantify any resulting influence. Finally, the registry reports zero affected participants for the listed adverse-event categories, but does not provide detailed event descriptions or safety follow-up completeness. These limitations do not determine what the unreported results would show; they constrain what can be concluded from the posted record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Lidocaine Administration Using STAR Particles — NCT06034340.
- Registry record last updated 2024-08-20; status last verified 2024-07.
- Results first posted 2024-08-20.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT06034340 is a completed Emory University study of LET gel application after STAR particle pretreatment versus aloe gel pretreatment. It enrolled 22 participants, with both methods used on opposite arms of each participant. The registry lists the study as single-group, with allocation NA and masking NONE, and cautions that the comparison is not randomized or like-for-like.
The primary endpoint is the mean percentage of the application area reported as sharp rather than dull at 10 minutes or 20 minutes after LET gel application on Day 1. The registry record does not report the primary outcome estimates or their statistical analysis. For each arm, it reports 22 participants at risk and 0 affected by serious adverse events, 22 at risk and 0 affected by other adverse events, and 0 deaths.