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 Anti-reflux Control to Decrease Post Tonsillectomy Pain (NCT01777854), a randomized phase 4 study. The primary outcome is Pain After Tonsillectomy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01777854 |
| Phase | Phase 4 |
| Condition | Laryngopharyngeal Reflux, Throat Pain |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ascension Health |
| Results posted | Yes |
2. Clinical Question
Population
The planned participants were pediatric patients age 7-17 undergoing tonsillectomy. The registry lists laryngopharyngeal reflux and throat pain as conditions. It does not report the number of participants who completed the study or contributed outcome data.
Intervention
The intervention was a four-week course of omeprazole before tonsillectomy. The registry describes it as treatment intended to reduce reflux-related acid exposure in the oropharynx. The available description of the dosing criteria is incomplete, so further dosing details are not reported in the registry record.
Comparator
The comparison group was assigned a sugar pill. The registry describes the study as randomized and identifies omeprazole and sugar pill as the two groups. It does not report adherence, medication exposure, or whether participants and study staff remained unaware of assignment.
Primary question
The planned primary question was whether pain after tonsillectomy differed between participants assigned omeprazole and those assigned a sugar pill. The registry also describes collecting information about oral intake and postoperative problems. It reports no analyzed comparison or estimate of the effect on pain.
The study’s rationale was that silent laryngopharyngeal reflux might expose the surgical wound to acid, and that reducing this exposure before surgery might be associated with less postoperative pain. This is the rationale recorded for the trial, not an established finding from its results. The record lists the study as terminated and enrollment as 6, but does not report why the study was terminated or how many participants posted usable outcome data.
The clinical question therefore has a planned comparison and a described outcome, but no reported answer. No treatment effect, uncertainty interval, or statistical test for pain is reported in the registry record. The listing of enrollment alone does not establish that a comparative analysis was completed or that the enrolled participants contributed outcome measurements.
3. Trial Design
The registry identifies this as a Phase 4, randomized, parallel-group study with quadruple masking. Its narrative description calls the study prospective, randomized, and double blind. These descriptions differ in the stated degree of masking: the registry classification says quadruple, while the narrative says double blind. The record does not explain which people were intended to be masked or how masking was maintained.
The planned intervention was omeprazole for four weeks before tonsillectomy, with a sugar pill as the comparator. The registry describes children age 7-17 as the target participants. The omeprazole arm description includes a weight-based eligibility detail and a dose, but the text is truncated; further dosing information is not reported in the registry record. The sugar-pill description says its appearance differed from omeprazole and asserts this would not be an issue because participants would not know how the medications looked. The record does not describe a masking assessment.
The registry lists enrollment as 6 and status as terminated. It records a start date of 2013-01 and a primary completion date of 2015-07. These dates and the listed enrollment do not indicate how much follow-up was completed, whether every enrolled participant was randomized, or whether participants completed the planned questionnaire. Those details are not reported in the registry record. The reason for termination and any changes to the planned design are also not reported.
The planned outcome questionnaire covered pain and oral intake on postoperative days 0,1,3,5,7,10, and 14. The description says participants would return the form at a postoperative visit or mail it in. It also describes asking about problems such as hemorrhage or dehydration. The record does not say how returned questionnaires were checked, how incomplete assessments were handled, or which participants were included in any analysis.
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 | Omeprazole | Sugar Pill |
|---|---|---|
| STARTED | 3 | 3 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 3 | 3 |
Reasons for not completing this period:
| Reason | Omeprazole | Sugar Pill |
|---|---|---|
| Physician Decision | 3 | 3 |
Analysis population for the primary outcome, as defined in the registry: The patients did not receive the intervention
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 | Pre Treatment |
|---|---|---|
| Participants analysed | 6 | |
| Age, Categorical: <=18 years | Participants | 6 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 14 (7 to 17) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 3 |
| Region of Enrollment: United States | participants | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Pain After Tonsillectomy, measured over 2 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled “Pain After Tonsillectomy,” with a stated timeframe of 2 weeks. The registry describes a questionnaire asking about pain and oral intake across postoperative days 0,1,3,5,7,10, and 14. Its study summary says pain would be measured using a visual analog scale 1-10. The primary outcome description itself does not specify a scoring rule, a summary measure across assessment days, or which pain assessment would serve as the primary comparison. Those details are not reported in the registry record.
Pain is relevant to the stated study question because the intervention was intended to reduce reflux-related irritation of the tonsil fossas after surgery. Repeated assessments could describe how pain changes over the recovery period, while oral-intake reports provide additional information about postoperative experience. These are reasons such measures may be useful in a trial; they do not establish that the measure was completed or that the intervention changed the outcome.
The registry does not report observed pain scores, an arm-level summary, or a comparative estimate. It also does not report how missing questionnaire items or assessments were handled. The outcome is therefore described as planned, but its observed distribution and the precision of any comparison cannot be evaluated from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record contains a study plan and administrative status, not reported comparative results. It lists enrollment as 6, status as terminated, and the number of analyses as 0. No arm-specific outcome values, treatment-effect estimate, confidence interval, or test result for postoperative pain is reported. Consequently, the posted record does not establish whether pain differed between the omeprazole and sugar-pill groups, or how precisely any difference might have been estimated.
The primary outcome is pain after tonsillectomy, assessed by questionnaire over the stated 2 weeks. The study summary describes a visual analog scale 1-10 and lists postoperative assessment days. However, a planned measurement schedule is not the same as observed outcome data. The record does not state how many pain questionnaires were returned, how pain values were summarized, or what comparison was performed. It also does not report oral-intake results, despite describing oral intake as part of the questionnaire.
The registry’s stated enrollment does not provide an analysis denominator. It is not reported whether all enrolled participants were randomized, received the assigned medication, underwent tonsillectomy, completed follow-up, or were included in an outcome analysis. These gaps prevent assessment of how much information the study contributes to the clinical question. The record also does not state why the study was terminated, so no reason for the lack of reported analyses can be inferred.
The adverse-event listing names a “Pre Treatment” group and records zero at risk and zero affected for serious and other events. Because the record does not show a treated comparison or explain the scope of this entry, those zero counts should not be interpreted as evidence that no adverse events occurred during the planned treatment or postoperative period. The record does not report a usable adverse-event comparison between the randomized groups.
In general, a confidence interval communicates the range of effects compatible with the observed data under the analysis assumptions. No such interval is reported for this trial. The absence of an estimate and interval means neither the magnitude of a possible difference nor its statistical precision can be judged from the registry results. It is not appropriate to infer a null effect from the absence of posted results.
The registry includes planning assumptions describing a normal approximation, equal allocation, and a two-sided significance level of 0.05 for sample-size illustrations based on a fraction of an observed effect. These are planning assumptions, not evidence that the study conducted a test using that method. The record reports no observed effect or completed analysis, and no trial-specific statistical analysis plan is reported. Any sample-size illustration based on those assumptions should not be treated as an observed finding or as a measure of the study’s achieved power.
9. Statistical Methods Explained
What does randomization contribute?
Randomization assigns participants to study groups using a chance-based process. In general, this can reduce systematic differences between groups at the time of assignment, making a later comparison more interpretable. It does not guarantee that groups will be alike in every characteristic, particularly in a small study, and it does not correct for missing outcome data or departures from the planned treatment. The registry labels the study randomized, but the sequence-generation method, allocation concealment, and implementation details are not reported in the registry record.
The parallel-group model means participants were intended to remain in an assigned group rather than cross over between treatments. The planned comparison was omeprazole before tonsillectomy versus a sugar pill. The registry does not report whether participants actually received their assigned treatment or how adherence was assessed. Thus the design classification describes the intended structure, not necessarily the treatment exposure represented in any completed analysis.
What does masking mean in this record?
Masking is intended to limit the influence of treatment knowledge on behavior, outcome reporting, and assessment. The registry classification says quadruple masking, while the study narrative says double blind. The record does not identify the masked roles or reconcile the labels. It also notes that the placebo did not look like omeprazole, but does not report whether that difference affected masking. No conclusion about successful masking can be drawn from the label alone.
How should the pain outcome be understood?
The study summary describes pain measured on a visual analog scale 1-10. In general, a visual analog scale is a patient-reported measure in which a person indicates the intensity of a symptom along a scale. Its interpretation depends on how the scale is presented, how values are recorded, and how the resulting measurements are analyzed. The registry does not report a detailed scoring procedure, a primary summary across the listed assessment days, or a prespecified contrast between groups. Without those details and observed data, the intended measurement cannot be translated into a treatment-effect estimate.
Repeated assessments can capture the course of a symptom over time. They can also create analysis choices: investigators may compare groups at a selected time, summarize outcomes across time, or model the repeated measurements jointly. These are general options, not methods confirmed for this study. The analysis method for the listed postoperative assessments is not reported in the registry record. The outcome title gives a timeframe of 2 weeks, but it does not specify which assessment or summary defines the primary result.
What can a statistical comparison establish?
In general, a statistical comparison estimates how outcomes differ between groups and quantifies uncertainty around that estimate. A confidence interval conveys which values remain compatible with the observed data and model assumptions. A test result addresses a specified statistical hypothesis under a specified analysis. Neither the estimate, interval, nor test result is reported for this trial. As a result, the strength and precision of any comparison cannot be evaluated.
A p-value, when reported, is interpreted in relation to a prespecified hypothesis and a statistical model. It is not a measure of the probability that a treatment works, and it does not describe the size of an effect. The registry reports no p-value or analysis method for the primary outcome. No inferential conclusion should be attributed to the planned randomization or outcome schedule in the absence of reported results.
What do the planning assumptions say?
The registry’s sample-size description says planning illustrations use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. It also distinguishes the type of quantity that would be counted for time-to-event illustrations from participant counts for other illustrations. This describes planning conventions; it does not identify a completed analysis or show that the trial was designed using a particular effect estimate.
The record reports no observed effect and no completed analyses. Therefore, no actual sample-size illustration tied to an observed effect can be interpreted as a trial finding from the registry results. In general, sample-size calculations are planning tools that depend on assumptions about the effect, outcome variability, allocation, and statistical method. They do not describe the information actually collected, and they are not observed power. The registry does not report a trial-specific sample-size justification or the assumptions used when the study was initiated.
Why does over-dispersion matter generally?
For outcomes analyzed with count-based models, over-dispersion means the observed variability is greater than the model’s basic assumptions allow. If ignored, standard errors and uncertainty intervals can be too small, making results appear more precise than the data justify. This is a general statistical issue, not a method reported for this study. The primary outcome is described as questionnaire-based pain, and the registry does not report a count model or any model that addresses over-dispersion.
10. Multiplicity, Missing Data and Analysis Populations
The questionnaire includes repeated postoperative assessments on days 0,1,3,5,7,10, and 14, and it covers both pain and oral intake. This creates the possibility of multiple outcome comparisons or time-specific tests. In general, conducting many tests can increase the chance of a statistically notable finding arising by chance unless the analysis plan accounts for the testing structure. The registry does not report a multiplicity strategy, such as a designated primary time point, a hierarchy of outcomes, or an adjustment procedure. It is therefore not possible to determine how multiple comparisons would have been handled.
The primary outcome is titled “Pain After Tonsillectomy” and has a timeframe of 2 weeks, but the record does not identify a single primary assessment day or a summary measure across the repeated assessments. Oral intake and postoperative problems are also described in the questionnaire, but their status as secondary outcomes and their analysis methods are not reported in the registry record. No outcome-specific results are posted.
Missing-data handling is also not reported. The study description allowed forms to be returned at a postoperative visit or mailed in, but does not state how nonreturned forms, incomplete responses, or missed assessment days were handled. It does not report whether a complete-case analysis, imputation, or another approach was planned or used. Without these details, the risk of bias from missing outcomes cannot be assessed.
The analysis population is not reported. The registry includes a primary-outcome population entry stating “The patients did not receive the intervention,” but does not explain how this relates to the planned randomized groups or any analysis. There is no reported intention-to-treat population, per-protocol population, or treatment-received analysis. The record’s listing of enrollment does not establish the number included in an outcome comparison.
11. What the Result Does, and Does Not, Mean
The registry describes a clinical question: whether omeprazole given before tonsillectomy is associated with differences in postoperative pain compared with a sugar pill. It records the planned population, intervention, comparator, and questionnaire schedule. Those details explain the intended comparison, but they do not constitute evidence of a treatment effect.
The posted results do not report pain scores, oral-intake measurements, or a comparison between groups. No effect estimate or confidence interval is available to show the direction, size, or precision of a difference. The lack of a reported comparison does not mean the groups had identical outcomes, and it does not establish that the intervention did or did not affect pain.
The record lists enrollment as 6 and the study status as terminated. It does not state why the study ended, whether the listed participants completed follow-up, or whether data were analyzed outside the registry record. It is therefore not possible to distinguish among possible explanations for the missing results. Any explanation would be speculation.
The adverse-event entry should also be interpreted cautiously. It records zero at risk and zero affected in a group labeled “Pre Treatment,” but the record does not explain that group’s relationship to the planned randomized arms or define the period covered. These entries do not establish the absence of adverse events among participants exposed to study medication.
Overall, this record documents a planned randomized comparison but does not provide results that answer the clinical question. It cannot support a conclusion about the magnitude or precision of an effect, the completeness of follow-up, or the safety comparison between groups. The appropriate interpretation is that comparative outcome findings are not reported in the registry record.
12. Why This Trial Matters Statistically
This trial is statistically notable because its registry entry illustrates the difference between a detailed planned outcome and an analyzable reported result. The design describes random assignment, masking, a comparator, and repeated postoperative measurement. Yet the record reports no analyses and no comparative pain results. A protocol-level question can be clinically coherent while still yielding no posted estimate that readers can evaluate.
The repeated questionnaire schedule also makes clear why an outcome definition matters. Pain is described across multiple postoperative days, and oral intake is collected alongside it. Without a reported primary summary or analysis plan, readers cannot tell how the repeated measurements were intended to produce a single primary comparison or how other outcome tests would be interpreted. This is a general issue in studies that collect outcomes at several times.
The registry’s enrollment entry, status, and adverse-event listing also show why counts need context. Enrollment is not the same as the number analyzed, and a zero count in a group with zero at risk does not describe an exposed comparison. Clear reporting of participant flow, analysis populations, outcome completeness, and adverse-event denominators is needed to interpret trial results.
Finally, statistical significance and precision cannot be evaluated without estimates and uncertainty measures. The registry lists planning assumptions for sample-size illustrations, but does not report an observed effect or a completed analysis. Those planning details cannot substitute for results. The statistical value of this record is therefore primarily in documenting the intended design and identifying what outcome and analysis information is not available.
13. 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 limitation for interpreting this specific study is the absence of reported comparative outcome results. The registry lists enrollment as 6 and reports no analyses, so there is no posted estimate of pain or oral intake by treatment group. The reason for termination is not reported, and the record does not establish how many participants were randomized, treated, followed, or analyzed.
The endpoint description leaves important analysis details unspecified. Although the study summary describes a visual analog scale 1-10 and assessments on postoperative days 0,1,3,5,7,10, and 14, the registry does not state which measurement or summary was the primary endpoint for analysis. It does not report a scoring procedure, a comparison method, or how repeated observations would be handled. This limits interpretation of the planned outcome even apart from the absence of results.
The record’s design descriptions are not fully aligned: the registry identifies quadruple masking, while the narrative calls the study double blind. The masked roles and masking procedures are not reported. The omeprazole description is truncated, and the record does not describe treatment adherence or exposure. The population entry for the primary outcome says participants did not receive the intervention, without explaining its relationship to the planned comparison.
Missing-data procedures, analysis populations, multiplicity handling, and the trial-specific statistical plan are not reported in the registry record. The adverse-event entry has zero participants at risk and does not provide a usable comparison between the planned treatment groups. These reporting gaps preclude assessment of outcome completeness, analysis bias, and adverse-event rates.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Anti-reflux Control to Decrease Post Tonsillectomy Pain — NCT01777854.
- Registry record last updated 2018-10-24; status last verified 2018-09.
- Results first posted 2018-09-25.
- 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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17. Record Summary
The registry record describes a Phase 4 randomized, parallel-group study of omeprazole versus a sugar pill before tonsillectomy in pediatric patients age 7-17. The study was intended to assess postoperative pain and oral intake by questionnaire, with a stated primary-outcome timeframe of 2 weeks. The study summary describes pain measurement using a visual analog scale 1-10 and lists assessment days from postoperative day 0 through day 14.
The record lists enrollment as 6, status as terminated, and no reported analyses. It does not provide comparative pain or oral-intake results, analysis populations, missing-data procedures, or the reason for termination. The masking descriptions also differ between the registry classification and narrative. The entry therefore documents the intended clinical comparison but does not report findings that establish the direction, magnitude, or precision of an outcome difference.