Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture (NCT03749616), a randomized phase 4 study. The primary outcome is Number of Oxycodone Tablets Used for Breakthrough Pain..

2. Clinical Question

3. Trial Design

This was a Phase 4, randomized, parallel-group study with no masking reported. The registry lists University of Missouri-Columbia as the sponsor and gives an enrollment of 32. Its status is terminated. The reason for termination is not reported in the registry record, so the status alone does not explain why recruitment or follow-up ended.

The comparison was between an acetaminophen arm and an NSAID arm. In the NSAID arm description, ibuprofen was used alongside as-needed acetaminophen; oxycodone was available for breakthrough pain. In the comparator arm, acetaminophen was used for pain control and oxycodone was also available for breakthrough pain. Thus, assignment concerned the pain-control approach, while the primary outcome tracked oxycodone tablets used.

The reported primary endpoint was measured at 2 weeks. The record also names QuickDASH, PROMIS-UE, grip strength, key pinch strength, and wrist range of motion as secondary outcomes. It does not provide results for those outcomes in the registry record. The registry record does not report further details about randomization procedures, allocation concealment, participant eligibility, follow-up beyond the primary endpoint timeframe, or the reason the study was terminated.

Although the record lists an enrollment of 32, the primary-outcome arm summaries have their own participant counts, and the safety record has separate counts at risk. These counts describe different reporting contexts and should not be treated as interchangeable. The record does not explain the relationship among these populations. The planned sample-size justification and any interim analyses are not reported in the registry record.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Data were not collected due to 1.) incomplete medication diaries; and 2.) medication diaries not returned by participants.

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 Number of Oxycodone Tablets Used for Breakthrough Pain., measured over 2 weeks.

The primary endpoint was the number of oxycodone tablets taken per participant for breakthrough pain over 2 weeks. It is a count measure: each tablet used contributes to the participant-level total. The endpoint was intended to describe opioid consumption under the assigned pain-control approach, where oxycodone was available in both arms.

Counting tablets can provide a direct measure of recorded medication use, rather than relying only on a participant's general rating of pain. It does not, by itself, measure pain intensity, the reason a tablet was taken, adherence to the assigned non-opioid regimen, or whether pain control was adequate. Those questions require other measures and context. The registry record names patient-reported outcomes and physical measures among secondary outcomes, but does not report their results in the registry record.

The endpoint description says that the number and dosing of oxycodone tablets taken would be recorded. It also states that data were not collected because medication diaries were incomplete or were not returned. At the same time, the record lists mean tablet counts and standard deviations for both arms. The record does not clarify how these numerical summaries relate to its statement that the data were not collected. That ambiguity limits interpretation of the endpoint summaries.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous endpoint summarized by a mean and standard deviation. The endpoint itself is a count of tablets, but the posted summary parameter is the mean number per participant. A mean conveys the average recorded count in an arm. A standard deviation describes how dispersed individual recorded counts are around that mean. Neither statistic shows the full shape of the data. For a count outcome, individual values are whole-number counts and may be unevenly distributed; a mean and standard deviation can conceal clustering, skew, or unusually high values. The registry record does not provide a distribution plot or participant-level values in the registry record.

What would a confidence interval add?

In general, a confidence interval gives a range of estimates compatible with the data and the method used to calculate it. For a comparison, an interval around an estimated arm difference would help readers judge both the direction and the precision of that comparison. A narrow interval indicates greater precision under the model; a wide interval indicates more uncertainty. The registry record does not report a confidence interval for the primary endpoint or an inferential estimate of the arm difference. The reported arm means and standard deviations do not substitute for such an interval.

Why can count outcomes need careful analysis?

In general, counts can have a distribution unlike a continuous measurement with approximately symmetric variation. Some count outcomes show over-dispersion: their variability is greater than a simple count model expects. When over-dispersion is present, a model that assumes less variability can give confidence intervals that are too narrow and tests that are too optimistic. Other approaches can allow greater variability or avoid relying on a particular count distribution. This is a general consideration, not a claim that over-dispersion occurred in this study. The registry record does not report the participant-level data or analysis needed to assess the outcome distribution, nor does it state a model used for an arm comparison.

What does the missing comparison mean?

The record indicates that values were missing or not estimable for a two-arm comparison of this continuous endpoint, and it lists no analyses. This means no formal comparison result is available in the registry record. It is not evidence that the arms were equivalent, and it is not evidence that an effect was absent. Without an estimated comparison and its uncertainty, readers cannot evaluate the evidence for a difference or assess whether a clinically meaningful difference is ruled out.

The record's stated non-inferiority hypothesis would ordinarily require a defined margin and a method that assesses whether the data exclude effects beyond that margin. The margin, test, and associated interval are not reported in the registry record. Therefore, the hypothesis cannot be evaluated from the posted arm summaries alone. The record also does not specify an analysis model, covariate adjustment, or method for handling incomplete diaries.

How should planning illustrations be read?

General sample-size planning asks how many participants per arm might be needed under chosen assumptions to detect an effect with a chosen error rate and power. The planning description associated with this record says its illustrations use the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. These are planning assumptions, not the trial's own design justification. Any resulting sample-size figures are hypothetical planning illustrations, not observed power and not evidence that the study had adequate power. The registry record does not report its own sample-size justification.

Because the primary endpoint comparison is not reported, an observed effect used for planning should not be mistaken for a tested or confirmed effect. Planning calculations based on an unstable estimate can also be sensitive to that estimate. This is a general statistical caution; it does not establish what motivated this trial's design. The record does not report interim analyses or a statistical analysis plan, so neither should be inferred from the summaries.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Acetaminophen", "NSAID")
n   <- c(7, 13)
m   <- c(16.71, 9.92)
sp  <- c(12.01, 11.98)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Acetaminophen  7  16.710  12.010  5.603  27.817
CARM  NSAID  13  9.920  11.980  2.681  17.159

11. Multiplicity, Missing Data and Analysis Populations

The registry record identifies one primary endpoint and names secondary outcomes covering QuickDASH, PROMIS-UE, grip strength, key pinch strength, and wrist range of motion. Testing multiple outcomes can increase the chance of obtaining at least one apparently notable result by chance if each is assessed separately. In general, a statistical plan can address this through prespecified testing order or adjustments, depending on the goals of the study. Whether any such approach was planned or used is not reported in the registry record. The record lists 8 outcome measures and no analyses; it does not provide results for the named secondary outcomes in the registry record.

Missing primary-outcome information is a central limitation. The endpoint description attributes non-collection to incomplete medication diaries and diaries not returned by participants, while the results list arm means, standard deviations, and endpoint counts. The record does not clarify how these summaries were obtained or how missing diary data were handled. It does not report whether missingness was related to pain, medication use, study assignment, or other factors. No missing-data method or sensitivity analysis is reported, so the direction or extent of any resulting bias cannot be determined.

The registry record does not report the analysis population definitions, such as whether analyses were intended to follow randomized assignment or include only participants with recorded diaries. The endpoint counts and safety counts are distinct reporting populations, and the record does not explain their relationship. The reason for termination and any effect it had on data collection are also not reported. These gaps prevent a clear account of how the planned study population became the population represented by each posted result.

12. 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 record lists no serious adverse events affected in either group: 0 among 14 at risk in the acetaminophen group and 0 among 18 at risk in the NSAID group. It also lists 0 other adverse events affected in each group and 0 deaths in each group. These figures describe what was recorded in the safety entries; they do not establish that no adverse events occurred outside the recorded information.

The safety counts at risk are not the same as the arm counts listed for the primary endpoint. The record does not explain the relationship between these populations, so they should not be combined or treated as interchangeable. With no additional detail about event ascertainment, follow-up, or reporting completeness, the figures provide a limited account of recorded events. The absence of a reported event is not proof of absence of risk, and the registry record does not support conclusions about comparative safety.

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

The registry record provides descriptive primary-endpoint summaries for oxycodone tablet use at 2 weeks, along with standard deviations and arm counts. It also reports no formal analysis of the two-arm comparison. Those summaries describe the posted data but do not answer whether NSAID use changed opioid consumption relative to acetaminophen, or how uncertain any difference might be.

The study's stated objective included non-inferiority for pain control and a reduction in opioid use. No non-inferiority margin, comparison estimate, or confidence interval is reported. The posted primary endpoint concerns tablet use; it is not itself a measure of pain control. The registry record also names patient-reported outcomes and measures of strength and motion, but the registry entries do not include their results. Accordingly, the stated aims should not be mistaken for conclusions about pain, function, strength, or opioid use.

The record's statement that medication diaries were incomplete or not returned, and that data were not collected, sits alongside numerical arm summaries. Without an explanation of this apparent inconsistency, it is unclear what observations the summaries represent. That uncertainty affects how readers should interpret even the descriptive statistics. The record does not establish whether the summaries represent all randomized participants, a subset, or another data source.

These limitations do not show that one approach is better or worse. They mean that the registry record, as described, does not support a firm comparative-effectiveness conclusion from the primary endpoint. The results also should not be generalized beyond the recorded study context without further evidence. They are not medical advice and do not establish what an individual should use for pain control.

14. Why This Trial Matters Statistically

This trial raises a useful statistical issue: a registry record can contain numerical arm summaries while not reporting an inferential comparison. A mean and standard deviation may look like a complete account at first glance, but they do not answer the same question as an estimated arm difference with uncertainty. The distinction matters whenever readers are asked to interpret whether groups differ, especially when the outcome data are limited.

The primary endpoint is a count of tablets, and the record links its collection to medication diaries. Diary completion and return are therefore directly relevant to how much confidence readers can place in the recorded outcome. The record explicitly notes incomplete or unreturned diaries but does not explain how this relates to the reported summaries. That makes transparent reporting of the analysis population and missing-data handling especially important.

The stated hypothesis also combines two ideas: non-inferiority for pain control and reduced opioid use. These claims concern different outcomes and require clear definitions and analyses. Tablet counts alone cannot establish pain-control non-inferiority, and a non-inferiority conclusion needs a prespecified margin and an appropriate comparison. The registry record does not report these details or a formal primary analysis.

Finally, the separate endpoint and safety counts illustrate why denominators need context. Counts reported for one outcome should not be assumed to describe the same participants as counts reported for another. Clear explanations of who contributed to each result, what was measured, and what was analyzed are essential for interpreting small clinical studies responsibly.

15. 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 record is terminated, but it does not report the reason for termination. It also does not report whether termination affected recruitment, follow-up, or outcome collection. The enrollment figure therefore does not by itself describe how many participants contributed usable primary-endpoint information.

A specific reporting ambiguity concerns the primary outcome. The endpoint description says data were not collected because diaries were incomplete or not returned, while the posted results include arm means, standard deviations, and endpoint counts. The record does not reconcile these statements. It also does not describe the source of the summaries, the handling of incomplete diaries, or the analysis population. This uncertainty limits interpretation of the primary endpoint independently of its lack of a formal comparison.

The primary endpoint is a tablet count, but the record reports it using means and standard deviations without additional distributional detail. It provides no participant-level data, confidence interval, p-value, or adjusted estimate in the registry record. No comparison analysis is reported. Consequently, neither the magnitude's precision nor the robustness of a comparison can be evaluated from the registry record.

The arm descriptions specify access to pain medications, but the record does not report adherence, actual dosing beyond the stated instructions, or other factors that might affect tablet use. It reports no analysis connecting tablet counts to pain ratings. The named secondary outcomes have no results in the registry record, and no multiplicity approach or analysis population is reported. These limitations leave the clinical interpretation and scope of the posted summaries uncertain.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture — NCT03749616.
• Registry record last updated 2024-09-05; status last verified 2024-08.
• Results first posted 2024-09-05.
• 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.

19. Record Summary

The registry record describes a Phase 4, randomized, parallel-group study with no masking reported, sponsored by University of Missouri-Columbia. It lists an enrollment of 32 and a terminated status. The comparison was NSAID use, specified as ibuprofen with as-needed acetaminophen, versus acetaminophen; oxycodone was available for breakthrough pain in both arms.

The primary endpoint was oxycodone tablets used per participant at 2 weeks. Posted arm summaries are a mean of 16.71 with standard deviation 12.01 for acetaminophen, and a mean of 9.92 with standard deviation 11.98 for NSAID. The record also states that medication-diary data were not collected because diaries were incomplete or not returned. No primary comparison analysis is reported, and the relationship between that statement and the posted summaries is not explained. Secondary outcomes are named, but their results are not included in the registry record.