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 Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption (NCT02453841), a non-randomized na study. The primary outcome is Blood Pressure Following Oxymetazoline Administration.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02453841 |
| Phase | NA |
| Condition | Adenoidectomy, Functional Endoscopic Sinus Surgery (FESS), Turbinate Surgery |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Richard Cartabuke |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing functional endoscopic sinus surgery, turbinate reduction surgery, or adenoidectomy. The registry describes the adverse-event group as children undergoing ENT surgery and records enrollment of 30. The number enrolled in each surgical cohort is not reported in the registry record.
Intervention
Topically applied oxymetazoline administered during surgery as part of standard care. The study was intended to assess hemodynamic effects and measure systemic absorption. Details such as dose and administration technique are not reported in the registry record.
Comparator
No separate untreated or alternative-treatment comparator is described. The listed arms correspond to surgical procedures in which patients received oxymetazoline. Allocation was nonrandomized, so these arms are not a like-for-like control comparison.
Primary question
What blood-pressure values were recorded after oxymetazoline administration during the perioperative period? The registry outcome specifies blood pressure in mmHg, recorded at 5 minute intervals until discharge from the post-anesthesia care unit or the final blood draw at 150 mins. after administration, whichever came first. The results are not reported in the registry record.
3. Trial Design
The registry describes a prospective study of oxymetazoline absorption and hemodynamic effects during functional endoscopic sinus surgery, turbinate reduction surgery, or adenoidectomy. The study status is completed, and enrollment is recorded as 30. The registry lists oxymetazoline as the drug intervention and describes its use as part of standard care during surgery.
The design is nonrandomized, unmasked, and parallel. The listed arms are patients undergoing functional endoscopic sinus surgery, turbinate reduction surgery, and adenoidectomy; patients in each arm received oxymetazoline during their procedure. Because the arms are based on different operations rather than randomized treatment assignments, comparisons between them would not isolate the effect of oxymetazoline from differences associated with the surgical procedures or their patient groups. The registry explicitly cautions that these are not like-for-like control comparisons.
The record does not describe a control arm without oxymetazoline, an alternative drug arm, or random allocation. The protocol details for oxymetazoline administration, including dose and timing beyond the outcome’s reference to administration, are not reported in the registry record. Nor are arm-specific enrollment figures or baseline characteristics reported in the registry record.
The primary outcome is blood pressure after administration. The registry also names ease of hemostasis and amount of bleeding as secondary outcomes. Although the record identifies the study as prospective, it does not report a detailed statistical analysis plan, a sample-size justification, or interim-analysis procedures.
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.
Overall Study
| Stage | Children Undergoing ENT Surgery |
|---|---|
| STARTED | 30 |
| COMPLETED | 27 |
| NOT COMPLETED | 3 |
Reasons for not completing this period:
| Reason | Children Undergoing ENT Surgery |
|---|---|
| Protocol Violation | 1 |
| Unable to obtain blood samples | 2 |
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.
| Characteristic | Unit | Children Undergoing ENT Surgery |
|---|---|---|
| Participants analysed | 30 | |
| Age, Categorical: <=18 years | Participants | 30 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 7 (SD 4) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 22 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Blood Pressure Following Oxymetazoline Administration, measured over 5 - 150 mins. after administration.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mmHg |
| Endpoint classification | Continuous Endpoint |
The primary outcome is blood pressure, measured in mmHg after oxymetazoline administration. The registry specifies a mean and standard deviation as the outcome summary. Measurements were to be recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw at 150 mins. after administration, whichever came first.
Blood pressure is a hemodynamic measure. In general, repeated measurements can describe how a measure changes over a period of observation, rather than relying on a single reading. The stated schedule also makes clear that the observation period could end at PACU discharge or at the final blood draw, whichever occurred first; the record does not say that every participant had measurements through the full stated period.
The registry’s endpoint description does not provide observed means, standard deviations, individual time-point results, or a summary of change from baseline. The definition of a baseline value, the specific blood-pressure measure or measures analyzed, and the approach to summarizing repeated observations are not reported in the registry record. Therefore the endpoint’s intended measurement can be described, but its observed pattern and precision cannot be evaluated from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies blood pressure following oxymetazoline administration as the primary outcome, but numerical primary-outcome results are not reported in the registry record. The record also lists 0 analyses. As a result, there is no posted estimate of the mean blood pressure, no standard deviation for the primary outcome, and no analysis describing change over the observation period. The endpoint definition alone cannot establish the direction or size of any hemodynamic change.
The study’s nonrandomized, parallel design is important to interpretation. The named arms represent different operations, with oxymetazoline used in each as part of surgery. They do not constitute a treatment group and a comparable untreated control group. Any differences among procedure cohorts could reflect the operations, patient characteristics, perioperative care, or other factors; the registry record does not report an analysis that separates such factors from drug-related effects.
The registry’s planned measurement schedule describes readings at 5 minute intervals until PACU discharge or the final blood draw at 150 mins. after administration, whichever came first. This specifies how observations were to be collected, not what those observations showed. No data are reported on the number or timing of measurements actually obtained, or on whether follow-up differed across patients.
The record names ease of hemostasis and amount of bleeding as secondary outcomes, but does not report their results or analyses. It also does not report systemic oxymetazoline concentrations, despite the study title and summary describing an assessment of systemic absorption. Without reported outcome values, uncertainty estimates, or analysis details, the magnitude and precision of any association cannot be judged.
Any sample-size figures associated with the record should be read as planning illustrations, not as observed power. The stated assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and detection of a stated fraction of an observed effect. Such an illustration does not show the probability that this completed study detected an effect. The registry record does not report the trial’s own sample-size justification, and no outcome estimate is available in the posted results to support a substantive interpretation.
9. Statistical Methods Explained
Statistical methods help distinguish what an outcome measures from what the data can support. In this record, the primary outcome is blood pressure in mmHg, summarized as a mean with a standard deviation. The registry specifies repeated readings after administration, at 5 minute intervals until PACU discharge or the final blood draw at 150 mins., whichever came first. However, the registry record does not report the observed readings, estimates, or an analysis of those repeated measurements.
What does a mean describe?
In general, a mean describes the arithmetic center of a set of numerical observations. It can provide a compact description of blood-pressure values, but it does not show how observations vary between participants or across measurement times. The registry names the mean as the outcome parameter, but it does not report a mean value or clarify whether the intended summary applies to each time point, an interval, or another grouping of observations.
What does a standard deviation describe?
In general, a standard deviation describes the spread of observations around their mean. It is not the same as a confidence interval: a standard deviation characterizes variability among observations, while a confidence interval expresses uncertainty around an estimated quantity. Neither can be interpreted for this primary outcome because no numerical mean, standard deviation, or confidence interval is reported in the registry record.
Why do repeated readings require care?
Repeated blood-pressure readings from the same participant are related observations, rather than independent measurements from unrelated participants. In general, an analysis of repeated measurements needs to account for that within-participant dependence. Otherwise, the uncertainty around an estimated pattern may be represented incorrectly. The registry describes the collection schedule but does not report the statistical method used to analyze repeated readings, whether readings were combined, or how incomplete measurement sequences were handled.
What does nonrandomized allocation imply?
In general, random allocation can help make treatment groups comparable with respect to measured and unmeasured characteristics. Here, allocation is listed as nonrandomized, and the arms correspond to different surgical procedures in which oxymetazoline was used. Consequently, a contrast among these arms would combine differences associated with procedure and patient group with any differences in outcomes. The registry warns that the arms are not a like-for-like control comparison. It does not report an adjusted comparison or a method for addressing confounding.
How should planning calculations be read?
In general, a sample-size calculation describes a hypothetical design under specified assumptions; it is not a finding about the study’s observed results. The planning assumptions described for this record use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They frame the effect to detect as a stated fraction of an observed effect. Such calculated sample sizes are planning illustrations, not observed power. The registry record does not report the study’s own sample-size justification or a statistical analysis plan, and the posted results do not provide an effect estimate for interpretation.
What can a confidence interval add?
In general, a confidence interval gives a range of values compatible with an estimate under the statistical model used. Its width conveys precision: a wider interval indicates less precision than a narrower interval, all else being equal. A confidence interval does not by itself establish causation or clinical importance. No confidence interval for the primary outcome is reported in the registry record, so the precision of any blood-pressure estimate cannot be assessed.
The registry record lists 0 analyses. This means the posted record does not supply an inferential analysis to interpret alongside its outcome definitions. It does not justify assuming a particular test, model, adjustment strategy, or treatment-effect estimate. In general, methods should be matched to the outcome structure and the study design; for this record, the specific methods used are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary blood-pressure outcome and names ease of hemostasis and amount of bleeding as secondary outcomes. It records four outcome measures, but does not report an analysis for them. A multiplicity plan—how interpretation would account for testing several outcomes or time points—is not reported in the registry record. Without that information and without posted results, the risk of overinterpreting a favorable finding among multiple analyses cannot be assessed.
Missing-data procedures are also not reported in the registry record. The primary outcome was to be measured repeatedly until PACU discharge or the final blood draw at 150 mins. after administration, whichever came first. The record does not report how many readings were obtained, whether some readings were unavailable, why measurements might be missing, or how incomplete follow-up was handled in analysis.
The analysis populations are not reported in the registry record. There is no description of which participants or observations would be included in each outcome analysis, or how exclusions would be handled. Although enrollment is recorded as 30, the record does not give arm-specific enrollment or outcome-specific denominators. No assumptions about complete measurement, exclusions, or the treatment of missing data can therefore be made from the posted record.
The registry also does not report interim analyses or stopping rules. Those details, like a prespecified multiplicity strategy and a complete statistical analysis plan, are not reported in the registry record. Their absence from the record does not establish what procedures may have been considered elsewhere; it limits what can be evaluated from the registry information.
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 |
|---|---|---|---|
| Children Undergoing ENT Surgery | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Children Undergoing ENT Surgery | 0 of 30 |
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 |
|---|---|
| Children Undergoing ENT Surgery | 0 of 30 |
The registry’s adverse-event entry describes a group titled “Children Undergoing ENT Surgery.” It records 30 participants at risk for serious adverse events and 0 affected by a serious adverse event. For other adverse events, it records 30 at risk and 0 affected. The death count is 0. These are the counts reported for that listed group; they do not describe event types because no serious-event terms are listed.
These figures should be read as registry-reported counts, not as proof that oxymetazoline carries no risk. The record does not provide event definitions, ascertainment procedures, exposure details, follow-up duration for safety, or information about the completeness of reporting. It also does not give a comparison group without oxymetazoline. With no comparative safety analysis or uncertainty estimates reported, the counts cannot quantify differences in risk or rule out uncommon events.
The registry separately identifies different surgery arms, but the adverse-event entry does not give safety counts by procedure arm. It is therefore not possible to assess whether the recorded counts varied across those cohorts. The record’s zero counts are descriptive of the posted entry and should not be interpreted as a comparative estimate.
12. What the Result Does, and Does Not, Mean
This completed study was designed to assess hemodynamic effects and systemic absorption of topically applied oxymetazoline during functional endoscopic sinus surgery, turbinate surgery, or adenoidectomy. The registry identifies blood pressure after administration as the primary outcome and describes repeated measurements through PACU discharge or the final blood draw at 150 mins. after administration. It also names ease of hemostasis and amount of bleeding as secondary outcomes.
The posted record does not report numerical results for blood pressure, systemic absorption, hemostasis, or bleeding, and it lists 0 analyses. Therefore, it does not establish the size, direction, or precision of any observed outcome pattern. The fact that outcomes were specified in the registry is not evidence that a particular result occurred.
The study’s nonrandomized design also limits causal interpretation. The procedure arms received oxymetazoline as part of surgery, and no untreated or alternative-treatment control is described. Comparisons across those arms would not isolate the effect of oxymetazoline from differences between the surgical procedures and their patient groups. The registry itself cautions that the arms are not like-for-like controls.
The adverse-event entry records 0 serious adverse events, 0 other adverse events, and 0 deaths among 30 at risk in the listed group. These counts are descriptive and do not demonstrate an absence of risk, establish comparative safety, or address events not captured in the registry entry. More detailed safety methods and outcome analyses are not reported in the registry record.
Accordingly, the registry supports a description of the study question, design, intended measurements, and reported adverse-event counts. It does not support a conclusion about whether oxymetazoline changed blood pressure, how much systemic absorption occurred, or whether its use altered bleeding or hemostasis outcomes.
13. Why This Trial Matters Statistically
This study raises a statistical question that is common in perioperative research: how to describe a physiological measure recorded repeatedly during clinical care. Repeated blood-pressure readings can capture a time course, but the observations from a single participant are related. A suitable analysis must reflect that structure and account for the fact that observation may end at PACU discharge or at the final blood draw, whichever comes first.
The design also illustrates why the comparator matters. The listed arms correspond to different surgical procedures, and oxymetazoline was used in each as part of standard care. These groups can describe outcomes in different procedure settings, but they do not supply a randomized, untreated comparison. Statistical adjustment, even if it had been reported, would not turn these arms into randomized groups; the record does not describe any such adjustment.
Another important lesson is the distinction between a registered outcome and a reported result. The record defines blood pressure as the primary endpoint and identifies secondary outcomes, but gives no numerical outcome estimates and lists 0 analyses. Without estimates and measures of uncertainty, readers cannot judge the size or precision of the findings. A completed status alone does not fill that evidence gap.
Finally, safety counts require context. The registry records zero events in the listed categories, but the entry does not provide event definitions, comparative data, or detailed follow-up information. Statistical interpretation depends not only on the count but also on how events were collected, the population observed, and the existence of an appropriate comparator. Those details are not reported in the registry record.
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 most immediate limitation for interpretation is that the registry record does not report numerical primary or secondary outcome results. It lists 0 analyses, so neither effect estimates nor their precision can be evaluated. The record also does not provide blood-pressure values by time point, a summary of change, or the systemic absorption measurements described in the study summary and title.
The study is nonrandomized and has no separately described untreated or alternative-treatment control arm. Its procedure-based arms are not like-for-like controls, as the registry notes. Any observed differences across arms could be related to the operation or the patients undergoing it, as well as other factors. Arm-specific enrollment and baseline characteristics are not reported in the registry record.
The endpoint description leaves important analytic details unspecified. A baseline definition, the exact blood-pressure measure analyzed, the handling of repeated observations, and the summary method across the measurement period are not reported. Nor are the number of actual readings, missing-data procedures, or analysis populations. Because measurement could stop at PACU discharge or the final blood draw at 150 mins., the record does not establish that observation length was the same for all participants.
Safety reporting is limited to aggregate counts for the listed group. Event definitions, ascertainment, timing, and procedure-specific counts are not reported in the registry record. The record also does not report a multiplicity approach, interim analyses, a detailed statistical analysis plan, or the trial’s own sample-size justification. These gaps prevent a fuller assessment of design implementation and statistical precision.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption — NCT02453841.
- Registry record last updated 2018-09-18; status last verified 2018-09.
- Results first posted 2018-09-18.
- 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
The registry describes a completed, prospective, nonrandomized, unmasked, parallel study of oxymetazoline used during functional endoscopic sinus surgery, turbinate reduction surgery, or adenoidectomy. Enrollment is recorded as 30. The primary outcome is blood pressure in mmHg, summarized as a mean and standard deviation, with readings scheduled at 5 minute intervals until PACU discharge or the final blood draw at 150 mins. after administration, whichever came first.
Ease of hemostasis and amount of bleeding are listed as secondary outcomes. The adverse-event entry reports 0 serious adverse events, 0 other adverse events, and 0 deaths among 30 at risk in the listed group. Numerical results for the primary and secondary outcomes, systemic absorption, and statistical analyses are not reported in the registry record. The study arms represent different surgeries and are not a like-for-like control comparison.