Parental Perceptions on Prescription Opioid Use: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Parental Perceptions on Prescription Opioid Use (NCT05344118), a registered phase not stated study. The primary outcome is Comfort With Child Receiving Opioids During Surgery.

2. Clinical Question

The clinical question is about parental perceptions, not about comparing opioid use with another pain-control strategy or measuring the effects of opioids on children. The survey addresses a particular setting—children undergoing orthopedic surgery—and asks about comfort with opioid receipt during surgery. It therefore captures a stated parental view in that context. It does not, by itself, establish what medication a child received, how pain was controlled, or what clinical outcomes followed.

The registry record lists employment status, education, gender of child, and age of child among secondary outcomes. Those variables could describe the surveyed participants or be considered alongside their responses, but the record does not report the corresponding results or analyses. The clinical question remains descriptive: what responses did parents give, and how were those responses distributed? Since the primary count and response definitions are not reported in the registry record, the posted information does not answer that question with an estimate.

3. Trial Design

The study is titled “Parental Perceptions on Prescription Opioid Use” and its official title specifies pain control in children undergoing orthopedic surgery. The registry describes an anonymous survey given to parents about their perceptions of prescription opioid use in that setting. It lists the intervention as “Survey” and identifies the participant group as parents of children undergoing orthopedic surgery.

The registry record reports enrollment of 125. The study start date is 2022-03-25, the primary completion date is 2022-07-18, and the status is COMPLETED. Nationwide Children's Hospital is listed as the sponsor. These details identify the setting and administrative status; they do not establish how the survey was administered, how parents were approached, or how many people were eligible or invited.

No randomized comparison is described. The registry record does not state an allocation method, and the listed group is not a like-for-like control comparison. The study should therefore be read as a survey of parental perceptions, not as a trial that contrasts assigned clinical treatments. There is no reported comparator arm against which to interpret the primary question.

The primary outcome is titled “Comfort With Child Receiving Opioids During Surgery,” has a Baseline timeframe, and is expressed as a count of participants. The record lists 10 outcome measures, including the primary measure and secondary outcomes, but does not report their results. It also does not report an analysis plan or statistical analyses. Details such as survey wording beyond the primary question, response options, recruitment procedures, handling of incomplete questionnaires, and sample-size justification are not reported in the registry record. Those omissions limit assessment of how representative the responses are and how the recorded endpoint was derived.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Comfort With Child Receiving Opioids During Surgery, measured over Baseline.

The primary endpoint concerns whether a parent is comfortable with their child receiving opioids during surgery. The registry’s question gives Morphine, Fentanyl, and Dilaudid as examples and identifies the timeframe as Baseline. It expresses the outcome as a count of participants, so the intended summary is a number of people associated with the recorded response rather than a continuous measurement such as a score or a duration.

A survey endpoint is useful for describing attitudes that may not be captured by clinical measures such as medication exposure or pain scores. In this study, the endpoint is relevant to the stated aim of understanding parental perceptions in pediatric orthopedic surgery. It can represent parents’ stated comfort in the context of the question asked, but it is not itself a measure of a child’s treatment, pain, safety, or recovery.

The registry record does not report the observed count, the denominator used for the primary endpoint, or the response choices and coding rules. It is therefore not possible to tell from the posted information how many parents were classified as comfortable, whether responses were recorded in more than two categories, or how incomplete responses were treated. The enrollment of 125 does not establish that all enrolled participants contributed a usable primary response. Without the endpoint result and its analysis population, the registry entry does not quantify the level of parental comfort.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

For a binary endpoint, a common descriptive summary is a count of participants in a response category, sometimes accompanied by the number of participants who answered the relevant question. The registry identifies this primary outcome as a count of participants. The exact response categories, coding convention, observed count, and analysis denominator are not reported in the registry record. Without those details, the endpoint cannot be reconstructed or independently interpreted from the enrollment number alone.

What does a count describe?

A count describes how many observations meet a stated definition. For survey data, that definition depends on the wording of the question and the way responses are grouped. If a question allows several choices, combining answers into a binary category requires a rule. If answers are omitted or unusable, the reported count may use fewer respondents than the total enrolled. These are general measurement considerations; the registry record does not state the response options, grouping rules, or missing-response procedure used in this study.

In general, a proportion can help place a count in context by relating it to the number of respondents with usable data. That denominator must be clearly defined: it may be all enrolled participants or only those who answered the item. The registry record reports enrollment of 125 but does not report the primary endpoint denominator or the primary outcome value. No proportion can therefore be interpreted from this record, and no percentage should be inferred from the enrollment figure.

What would precision mean for this endpoint?

In general, a confidence interval communicates the uncertainty around an estimate under a specified statistical method and assumptions. For a survey response, it can indicate how precisely the response level has been estimated in the analyzed sample. The interval does not address every source of uncertainty: it does not automatically account for selection into the survey, nonresponse, unclear measurement, or limited representativeness. The registry record does not report an estimate, confidence interval, or other uncertainty measure for the primary endpoint.

A p-value, in general, summarizes how compatible the observed data are with a specified statistical model or null hypothesis. It is not a measure of the size or practical importance of an association, and it does not reveal whether a survey result is unbiased. No p-value or hypothesis test is reported for this study. Since no comparator or analysis is stated, the posted information offers no basis for interpreting a test of differences.

How should the study design shape analysis?

The study is described as an anonymous survey and has a listed parent group without a like-for-like control comparison. Descriptive summaries would be a natural way to present the primary response, provided the response definition and denominator were made clear. Comparisons between participant characteristics would require explicit methods, careful handling of sparse response categories, and attention to how many comparisons were made. The registry does not report such methods or results. The outcome list includes employment status, education, gender of child, and age of child, but their presence alone does not show that subgroup analyses were conducted.

In general, over-dispersion matters when observations vary more than an analysis model expects. If a model assumes a particular level of variability but the responses are more heterogeneous, standard errors may be too small and confidence intervals too narrow. Whether over-dispersion is relevant depends on the outcome structure and analysis model. The registry record does not report a model or enough outcome detail to assess this issue for the study.

What can sample-size illustrations establish?

General sample-size illustrations can show how a hypothetical study might be planned under chosen assumptions about an effect, significance level, allocation, and statistical method. They are planning aids, not descriptions of the completed survey’s observed findings. The registry’s planning assumptions describe an illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The record does not describe a two-arm comparison or a like-for-like control group, and it does not report the observed primary effect needed for such an illustration. The registry record does not report the study’s own sample-size justification or design assumptions. Any planning illustration should therefore not be read as evidence about what the survey found or as observed power.

For a time-to-event outcome, general planning methods may express a required total number of events; other methods may express participants per arm. Those conventions do not turn this survey into a comparative or time-to-event study. The listed primary endpoint is a participant count, and the registry does not report a time-to-event measure. More broadly, a sample-size calculation cannot compensate for missing endpoint definitions, unknown response rates, or absent outcome results.

Finally, interpretation depends on transparency about the analysis population, data processing, missingness, and prespecified methods. These details help readers distinguish a planned analysis from an exploratory one and understand which participants contribute to each estimate. The registry record does not report these analytical details. As a result, methodological explanations can clarify what information would be needed, but they cannot supply an estimate or reconstruct the study’s analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 10 outcome measures. The primary outcome concerns parental comfort with a child receiving opioids during surgery; secondary outcomes include employment status, education, gender of child, and age of child. The record does not describe whether the outcomes were tested, how they were prioritized beyond the identified primary outcome, or whether any adjustment for multiple comparisons was planned. Analyses are not reported in the registry record.

Multiplicity is a general concern when several outcomes, subgroups, or statistical comparisons are examined. Conducting many tests can increase the chance that at least one result appears notable by chance. Approaches to multiplicity depend on the scientific aims and analysis plan; no particular approach can be attributed to this study based on the registry entry. Because no outcome estimates or tests are reported, there is no reported pattern of findings whose multiplicity adjustment can be assessed.

The survey is described as anonymous, but the registry record does not explain how incomplete questionnaires or skipped items were handled. It does not report the number of missing primary responses, whether participants with missing data were excluded, or whether any imputation was used. The enrolled population is 125, but the analysis population for the primary outcome is not reported. This prevents assessment of whether the endpoint count reflects all enrolled participants or a subset with usable responses.

The record also does not state whether analyses were limited to a prespecified population or whether any participants were excluded after enrollment. No analysis population definition is reported in the registry record. These omissions matter because response patterns among participants with complete answers may differ from those among participants who did not respond. Without counts and procedures for missing data and analysis inclusion, the completeness and representativeness of the endpoint summary cannot be evaluated.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry safety figures list the Parents group with 125 participants at risk for serious adverse events and 0 affected. The corresponding figures for other adverse events are also 125 at risk and 0 affected. Deaths are listed as 0, and no top serious adverse-event terms are listed.

These entries are registry counts, not a comparative safety analysis. The study is described as an anonymous survey about perceptions, and no treatment comparator is reported. The figures do not show that participants were assigned opioids or that the study evaluated children’s clinical safety outcomes. They should be read only as the adverse-event information recorded for the listed group in this registry entry.

A zero affected count means that the record lists no affected participants in the corresponding category; it does not, on its own, establish how adverse events were defined, monitored, solicited, or verified. The registry record does not report those procedures or additional safety analysis. It also does not provide a comparison that would support estimating a relative safety difference. Accordingly, the figures should not be interpreted as evidence about the safety of opioid use in children or as evidence that adverse events could not occur.

12. What the Result Does, and Does Not, Mean

The record establishes that a completed study used an anonymous survey to ask parents about perceptions of prescription opioid use for pain control in children undergoing orthopedic surgery. It identifies the primary topic as parental comfort with a child receiving opioids during surgery, and reports enrollment of 125. These registry entries describe the study’s scope and the question it set out to address.

The record does not report the primary response count, the response denominator, or a measure of uncertainty. It therefore does not show how parents answered the question or how precisely the surveyed response was estimated. The listed enrollment cannot substitute for the missing outcome result. The record also does not report analyses of employment status, education, gender of child, or age of child, so no relationship between those characteristics and parental responses can be described.

The study question is about stated perceptions. A survey answer is not the same as a child’s actual medication exposure, pain experience, or clinical outcome. Nor does a descriptive survey without a stated comparator estimate the effect of one treatment strategy relative to another. The posted information does not support a conclusion about the benefits or harms of opioid use, or about what parents generally believe beyond the surveyed participants.

In general, interpreting survey findings also requires attention to who was invited, who responded, how questions were presented, and how answers were classified. The registry record does not report these details beyond describing the survey as anonymous and identifying its central question. Even if a response estimate were available, those design and participation details would shape how broadly it could be applied.

The careful conclusion is limited: the registry documents a completed survey study of parental perceptions, but its outcome results and analysis are not reported in the registry record. The record therefore defines a relevant descriptive question without supplying the data needed to answer it.

13. Why This Trial Matters Statistically

This study raises a statistical issue that often arises in clinical research: a clearly stated question is not the same as a reported result. The registry identifies a focused survey question and names a participant group, but a count endpoint is interpretable only when the observed count, its denominator, and the response definition are available. Those outcome details are not reported in the registry record. Readers can identify the intended subject of measurement but cannot quantify the responses.

It also illustrates why the design type matters. A survey about parental perceptions can describe responses in its participants, while a treatment comparison addresses a different question and requires a suitable comparator and analysis. No like-for-like control comparison is described. Reading a descriptive survey as though it tested a clinical treatment effect would confuse reported attitudes with clinical outcomes.

Another important distinction is between enrollment and the analysis population. Enrollment of 125 is useful context, but it does not reveal how many participants answered the primary item or whether responses were complete. Transparent reporting of the endpoint denominator and missing data would help readers judge the scope and precision of any summary. The registry record does not report those details.

Finally, the entry lists multiple outcome measures but reports no analyses. Statistical interpretation depends not only on the number of outcomes but on which questions were prespecified, what comparisons were made, and how uncertainty was represented. Without estimates and methods, there is no basis for evaluating multiplicity, precision, or subgroup findings. The statistical importance of this record is therefore chiefly methodological: it shows why complete outcome reporting is needed to move from a study description to an interpretable finding.

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 principal limitation for interpreting this study from the registry record is the absence of reported outcome results. Although the primary endpoint is identified as a participant count, the count itself, its denominator, and the response categories are not reported. This prevents a quantitative description of parental comfort and makes it impossible to assess precision.

The registry describes the study as an anonymous survey, but does not report how participants were recruited, how many were approached, response rates, or the setting in which the questionnaire was completed. It does not provide survey validation information, the full questionnaire, or rules for classifying responses. These missing details limit assessment of measurement quality and selection or nonresponse concerns.

Enrollment is reported as 125, but the registry does not state how many participants contributed to each outcome. The handling of skipped items, incomplete surveys, or exclusions is not reported. This makes it unclear whether the primary endpoint, if analyzed, would represent all enrolled participants or a smaller group.

The record lists 10 outcome measures but does not report a statistical analysis plan or results. It does not describe any subgroup analyses, multiplicity approach, or method for estimating uncertainty. No control group or allocation method is stated, so the study cannot be read as a like-for-like comparative trial. The registry also does not report the study’s sample-size justification. These limitations are specific to the available record; they do not establish that the underlying study lacked procedures, only that those details are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Parental Perceptions on Prescription Opioid Use — NCT05344118.
• Registry record last updated 2024-06-28; status last verified 2024-06.
• Results first posted 2024-06-28.
• 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.

18. Record Summary

NCT05344118, “Parental Perceptions on Prescription Opioid Use,” is listed as COMPLETED and sponsored by Nationwide Children's Hospital. The study is described as an anonymous survey of parents of children undergoing orthopedic surgery. Enrollment was 125; the study started on 2022-03-25, and primary completion was 2022-07-18.

The primary outcome asks about comfort with a child receiving opioids during surgery and is expressed as a count of participants, with a Baseline timeframe. Secondary outcomes listed are employment status, education, gender of child, and age of child. The registry record does not report the primary or secondary outcome results, statistical analyses, response denominator, or handling of missing responses. No like-for-like control comparison or allocation method is stated. The recorded adverse-event figures list 0 affected for serious and other adverse events and 0 deaths among the listed group.