Toradol v. Celecoxib for Postoperative Pain: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Toradol v. Celecoxib for Postoperative Pain (NCT03331315), a randomized phase 2 study. The primary outcome is Average Inpatient Postoperative Pain Score.

2. Clinical Question

This is a question about the observed average pain scores in the trial, not a question answered by the arm means alone. The comparison estimate describes the direction and size of the mean difference, while its confidence interval describes the precision compatible with the posted summary statistics. The reported pain measure was a Visual Analog Scale. The registry record gives reference ranges for no pain, mild pain, moderate pain and severe pain, but states that subscale scoring was not used in the analysis. Those categories therefore help explain the scale’s reference points; they are not the analysis method used to produce the primary result.

The registry record describes a randomized control trial of ketorolac versus celecoxib for postoperative pain following hysterectomy. It does not report a more detailed primary population definition, eligibility criteria, or analysis-population rules. The clinical question should therefore be read in the context of the population and outcome information actually recorded, rather than extended to other operations, patient groups, or treatment schedules.

3. Trial Design

The registry record describes a Phase 2, randomized, parallel-group trial comparing Celecoxib with Ketorolac. Its status is completed. The recorded enrollment is 170. The reported arm summaries list 70 participants for Ketorolac and 68 for Celecoxib; the registry record does not explain the relationship between those arm figures and the enrollment figure, so they should not be treated as interchangeable counts.

The trial record lists no masking. It describes patients receiving scheduled ketorolac postoperatively in one arm and Celecoxib preoperatively and postoperatively for 7 days in the other. No dose, detailed administration schedule for ketorolac, or information about other perioperative care is reported in the registry record. Allocation is recorded as randomized, but the sequence-generation and allocation-concealment methods are not reported in the registry record.

The primary outcome is Average Inpatient Postoperative Pain Score, measured during the 48 hrs following surgery. The secondary outcome list includes average inpatient hydromorphone use, average inpatient ondansetron use, total hospital stay, perioperative complications, return to activities of daily living, and oral narcotic use after discharge. Numerical summaries are included for inpatient medication use and hospital stay; the record does not give further details about collection procedures for the other listed measures.

The recorded study start is 2013-09-01 and the primary completion date is 2016-06-30. The record does not report the original sample-size justification, the planned analysis model, an interim-analysis plan, or the protocol’s handling of missing observations. Those omissions limit reconstruction of the design and analysis decisions from the registry record alone. The posted arm summaries support descriptive comparisons, but they do not establish that the comparisons followed a specified adjusted analysis plan.

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:

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 Average Inpatient Postoperative Pain Score, measured over 48 hrs following surgery.

The primary endpoint is the average inpatient postoperative pain score during the 48 hrs following surgery. Pain was measured with the Visual Analog Scale and reported as a mean with a standard deviation. The registry record describes the scale in units on a scale and gives reference categories: no pain (0-0.4 cm), mild pain (0.5-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10.0 cm). It also says that subscale scoring was not used in the analysis; the categories were posted as reference for patients and nursing staff.

A mean provides a concise description of the average recorded score in each arm. Comparing arm means addresses whether average scores differed in the observed trial data, while the standard deviation describes the spread of individual scores around each arm’s mean. These answer different questions: the mean concerns the average, whereas the standard deviation describes variability among measurements.

In general, a pain score is used as an outcome because it translates a patient-reported experience into a measure that can be summarized and compared. Such a summary does not describe every participant’s experience, and an average does not indicate how many people fell into any of the reference categories. The registry record does not report a separate analysis of those categories. Nor does it report a clinically important difference threshold, so the observed mean difference cannot be classified against a trial-defined threshold for meaningful change.

7. Results Posted in the Registry

• Celecoxib: mean 2.40 versus 2.70 on control; difference -0.30 (95% CI -0.89 to 0.29), standardized effect d = -0.17; z-test p = 0.315.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Average Inpatient Hydromorphone Use

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Celecoxib: mean 0.80 versus 0.70 on control; difference 0.10 (95% CI -0.23 to 0.43), standardized effect d = 0.10; z-test p = 0.557.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Celecoxib and the control. The interval gives the range of effects that remain compatible with the data.

Average Inpatient Ondansetron Use

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Celecoxib: mean 1.30 versus 1.50 on control; difference -0.20 (95% CI -0.89 to 0.49), standardized effect d = -0.10; z-test p = 0.568.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Celecoxib and the control. The interval gives the range of effects that remain compatible with the data.

Total Hospital Stay

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Celecoxib: mean 11.90 versus 11.60 on control; difference 0.30 (95% CI -21.47 to 22.07), standardized effect d = 0.00; z-test p = 0.978.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Celecoxib and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover several aspects of the postoperative course: inpatient use of hydromorphone and ondansetron, total hospital stay, perioperative complications, return to activities of daily living, and oral narcotic use after discharge. The numerical summaries for the inpatient medication measures and hospital stay show estimates close to zero on their respective scales, with confidence intervals spanning zero. These summaries do not establish clear separation between the arms on those measures.

These outcomes relate to the primary pain result by addressing medication use, recovery and resource use alongside the pain score. They measure different things, however, and a difference in a medication-use measure would not itself establish a difference in pain. Conversely, the primary pain comparison does not settle the results for secondary outcomes. The registry record does not report a combined analysis that would turn the outcomes into a single overall measure.

Unadjusted secondary comparisons carry less weight when many outcomes are examined, because the chance of finding an apparently unusual result can increase across multiple tests. In general, multiplicity refers to the interpretive problem created by making multiple statistical comparisons. Adjustments or a prespecified hierarchy can address some of that problem, but the registry record does not report a multiplicity plan or adjusted secondary analyses. Secondary results should therefore be treated as descriptive and exploratory unless a fuller analysis plan establishes otherwise.

The registry record also lists outcomes for complications, activities of daily living and post-discharge narcotic use. Specific numerical findings for these measures are not reported in the registry record. The presence of an outcome in the list is not evidence of a particular result. In combination, the available secondary summaries provide context about several postoperative measures, but they do not override the uncertainty in the primary pain comparison or support a broad claim across all outcomes.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Average Inpatient Hydromorphone Use
• Average Inpatient Ondansetron Use
• Total Hospital Stay
• Number of Participants With Perioperative Complications
• Return to Activities of Daily Living
• Days of Oral Narcotic Use After Discharge
• Number of Oral Narcotic Pills Used After Discharge

9. Statistical Interpretation

10. Statistical Methods Explained

The posted primary comparison is a difference between two arm means. The registry record reports a mean and standard deviation for each arm, and the comparison is expressed as Celecoxib relative to Ketorolac. With that orientation, a negative difference means the observed mean is lower in the Celecoxib arm; a positive difference would mean it is higher. The estimate is -0.3, consistent with the posted arm means of 2.4 for Celecoxib and 2.7 for Ketorolac.

What does a mean difference describe?

A mean difference is a measure of the separation between two averages on the original outcome scale. It is not a percentage, a ratio, or a count of participants who improved. For this trial, the outcome is the average inpatient pain score, so the difference is expressed in the scale’s units. The record gives reference descriptions for ranges on the Visual Analog Scale, but it says those categories were not used for analysis. The reported comparison should therefore be interpreted as a contrast of means, not as a comparison of counts in pain categories.

The arm standard deviations describe how spread out scores were within each arm. A standard deviation is not the standard error of the mean. In general, the standard deviation concerns variability among observations, while the standard error concerns the uncertainty of an estimated mean. The primary outcome records standard deviations, and no arm-specific confidence limits are listed in the registry record.

What does the confidence interval add?

A confidence interval gives a range of estimates compatible with the data and the calculation’s assumptions. In general, it reflects both the size of the estimated difference and its precision. A narrower interval indicates greater precision than a wider interval, all else equal. For the primary comparison, the interval includes zero and extends to both negative and positive differences. That means the summary data do not pinpoint the direction of the underlying difference with high precision. The interval is not a range containing a fixed proportion of individual patient scores, and it does not assign a probability to the true value after the data have been observed.

The unadjusted p-value is 0.315. In general, a p-value evaluates how compatible data at least as extreme as those observed are with a specified null model. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of a difference. The registry record does not report an adjusted primary analysis or a fuller statistical analysis plan, so the posted p-value should be read as an unadjusted comparison rather than as evidence from an undocumented model.

Why do assumptions and analysis details matter?

Any summary-statistic comparison relies on assumptions about the data and the calculation. General examples include whether observations are independent, how the outcome distribution is handled, and whether the analysis accounts for design features or covariates. The registry record identifies a randomized parallel design, but does not report a detailed analysis model, diagnostic checks, or adjustment variables. It is therefore not possible to verify those choices from the registry record.

The trial is recorded as having no masking. In general, lack of masking can matter for outcomes involving subjective assessment, because expectations may influence reporting or measurement. That possibility is a design consideration, not proof that bias occurred in this trial. The pain outcome is a Visual Analog Scale, and the record does not give additional information about collection procedures or whether outcome assessors were masked.

The comparison figures are simple unadjusted re-calculations from the posted summary statistics, rather than a reported adjusted analysis. The registry record does not provide a sponsor-reported analysis to supersede these calculations, and the recorded discrepancy flag is false. Even so, a summary-statistic calculation cannot recover details unavailable in aggregated data, such as participant-level distributions, missing-data handling, or covariate adjustment. These methods explain the posted contrast; they do not reconstruct an undocumented protocol or establish that every analysis decision is known.

11. Confidence Intervals and Precision

The estimated primary mean difference is -0.3, with Celecoxib compared with Ketorolac. The confidence interval extends across zero, so its range is compatible with a lower Celecoxib mean, no mean difference, or a higher Celecoxib mean. This breadth matters: the point estimate alone gives a single best estimate from the calculation, but the interval shows that the estimate is uncertain.

In general, a confidence interval is useful because it combines information about the estimated contrast and its sampling uncertainty. It is not a guarantee that the true difference lies in the interval, and it does not describe the range of scores among individual patients. The primary interval’s inclusion of zero means the posted comparison does not distinguish the observed contrast from no difference at conventional levels by that interval criterion. The unadjusted p-value is 0.315, which is consistent with substantial uncertainty in the comparison; it should not be interpreted as a probability that the treatments are equivalent.

The arm summaries also show standard deviations of 1.9 for Ketorolac and 1.6 for Celecoxib. These indicate spread in recorded scores, not precision of the mean difference by themselves. Precision depends on the variability and the amount of information contributing to the comparison, as well as on the statistical assumptions. The registry record does not report an adjusted estimate, an analysis population definition, missing-data methods, or a prespecified clinically important difference. Those omissions limit how fully the interval can be contextualized.

Accordingly, the result is best read as a modest observed difference with an interval that does not rule out differences in either direction. It does not show that the arms are identical, and it does not establish a clinically meaningful advantage. A clinical-importance threshold is not reported in the registry record, so statistical uncertainty and clinical interpretation should remain separate.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size table and curve are planning illustrations based on the observed effect, not the trial’s original design calculation. The assumptions listed for those illustrations are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set at the stated fraction of the observed effect. The trial’s own original sample-size assumptions are not reported in the registry record. For these continuous outcomes, the figures are participants per arm, not total events.

The 80% power column gives the planned participants per arm for a hypothetical study to have an 80% chance of detecting the stated effect under the planning assumptions, if that effect and assumptions were correct. The 90% column uses a higher target chance of detection and therefore requires more participants per arm for the same assumed effect. These are prospective planning quantities, not a description of the probability that this completed trial detected a real difference.

For the primary outcome, the illustration based on 100% of the observed effect gives 540 participants per arm for 80% power and 723 participants per arm for 90% power. Planning for 75% of the observed effect gives 959 participants per arm for 80% power and 1,284 participants per arm for 90% power. Planning for 50% of the observed effect gives 2,158 participants per arm for 80% power and 2,889 participants per arm for 90% power. Smaller effects require more participants because they are harder to distinguish from sampling variation under otherwise similar assumptions. These figures are not observed power.

The illustration depends strongly on the observed effect, which is uncertain in this trial. If the true effect differs from the observed estimate, the corresponding planning figures may not apply. They also do not account for design or analysis features beyond the stated assumptions. The trial’s own original sample-size justification is not reported in the registry record, so the illustrations should not be read as evidence about why the recorded enrollment was selected.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.300; pooled standard deviation σ = 1.759.
2. n = 2 × (1.96 + 0.842)² × 1.759² / -0.300² = 539.4, rounded up to 540 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.3                      # observed difference in means
sigma <- 1.75861325715329                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3331315)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 540 (80% power), 723 (90% power)
 75% of observed effect: n per arm = 959 (80% power), 1,284 (90% power)
 50% of observed effect: n per arm = 2,158 (80% power), 2,889 (90% power)
power.t.test: 540.4 
Simulated power at n = 540 per arm: 0.802 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record lists multiple secondary outcomes in addition to the primary pain score. When several outcomes or comparisons are tested, the possibility of at least one apparently notable result can increase even if no true differences exist. This is the general multiplicity problem. A prespecified hierarchy, adjustment procedure, or clear distinction between confirmatory and exploratory analyses can help readers interpret a family of results. Such a plan is not reported in the registry record.

The posted secondary comparisons are unadjusted. Their p-values should not be treated as if they were the only tests conducted, and nominal statistical findings, if any, would need cautious interpretation in the context of the outcome list. The registry record does not report multiplicity-adjusted p-values, a primary-secondary testing hierarchy, or whether any secondary outcomes were designated as confirmatory. Therefore, the record does not establish how the investigators intended to control error across the collection of outcomes.

Missing-data handling is also not reported in the registry record. The arm summaries give outcome-specific participant counts, but they do not explain why those counts may differ from enrollment or whether observations were missing, excluded, or unavailable for a particular measure. The registry record does not report imputation, sensitivity analyses, or rules for handling incomplete measurements. Without those details, it is not possible to assess whether missing observations could have influenced the summaries.

The analysis populations are not described. The registry record does not state whether results were based on all randomized participants, participants who received treatment, or another defined group. Nor does it report exclusions or protocol deviations. Randomization supports a fair comparison when analyzed appropriately, but a reader cannot determine from the registry record alone how the analysis preserved that design feature.

These are limitations in the available reporting, not evidence that a particular method was or was not used. The registry record does not report the statistical analysis plan, interim analyses, or sample-size justification. As a result, the posted summaries can be interpreted as descriptive comparisons, while claims about prespecification, multiplicity control, missing-data robustness, or population-wide analysis remain unsubstantiated.

15. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse event figures list 0 participants affected in the Ketorolac arm among 70 at risk and 0 participants affected in the Celecoxib arm among 68 at risk. These are counts of participants with serious adverse events in the registry record, not counts of all events or measures of comparative risk. With no serious events recorded in either arm, these figures do not establish that the arms have identical safety profiles or that serious events cannot occur.

The record also lists other adverse events: 1 participant affected in the Ketorolac arm among 70 at risk and 2 participants affected in the Celecoxib arm among 68 at risk. The registry record does not provide further detail about the nature, timing, severity, or relationship of these other events to treatment. Deaths are not reported in the registry record, and no serious-event terms are listed.

Adverse-event counts are descriptive and should be read in light of the recorded trial size and reporting details. They do not alone establish causation or provide a complete account of safety. The record does not report additional safety analyses or follow-up details for these figures.

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

The posted primary data show average inpatient pain scores of 2.7 for Ketorolac and 2.4 for Celecoxib during the 48 hrs following surgery. The estimated mean difference, defined as Celecoxib relative to Ketorolac, is -0.3. The direction of the estimate corresponds to a lower observed mean in the Celecoxib arm. Its confidence interval crosses zero, and the unadjusted p-value is 0.315, so the comparison remains uncertain.

That uncertainty does not mean that the treatments are proven equivalent. Equivalence requires a prespecified margin and an analysis designed to assess whether differences fall within that margin; such a margin and analysis are not reported in the registry record. Nor does the result prove that one arm is superior. The observed point estimate is not sufficient by itself to establish a difference, and the confidence interval includes values on both sides of no difference.

The result also does not establish clinical importance. The registry record gives scale reference categories but does not report a threshold for a clinically important difference. An average score cannot show how every participant experienced pain, how many people improved, or how scores changed over time. The analysis described is a comparison of group means, not an individual-level response analysis or a comparison of pain categories.

The findings apply to the recorded study context: postoperative pain following hysterectomy, the treatment schedules described, and the inpatient assessment period. They do not automatically apply to other procedures, populations, settings or treatment schedules. The registry record describes a randomized trial but does not report detailed eligibility criteria, masking methods beyond no masking, or analysis-population definitions. Those gaps constrain conclusions about generalizability and the exact analysis basis.

Finally, secondary outcomes and safety counts add context but do not resolve the primary uncertainty. Unadjusted secondary comparisons require caution when multiple outcomes are considered, and some listed measures lack specific findings in the registry record. The most defensible reading is therefore a description of the observed group averages and their uncertainty, without a claim that either treatment works or does not work.

17. Why This Trial Matters Statistically

This trial is statistically informative as an example of the difference between an observed point estimate and a precise conclusion. The arm means differ, and the estimated contrast has a direction, but the confidence interval crosses zero. A reader who considered only the sign of the estimate could overstate what the data establish; a reader who treated the interval as proof of no difference would also overstate the result.

The posted standard deviations help distinguish variability in pain scores from uncertainty in the estimated average difference. The distinction is important in clinical research: participant-level outcomes may vary even when arm averages are close, and an average alone does not capture the full distribution. The record’s note that pain subscales were reference information rather than the analysis also illustrates why the stated measurement and the actual analysis need to be read together.

The trial also illustrates how registry reporting affects statistical interpretation. Randomization and a parallel design are recorded, but details about allocation methods, analysis populations, missing data, multiplicity, and the original sample-size justification are not reported in the registry record. Without those details, readers can describe the posted summaries but cannot reconstruct all design and analysis decisions.

Finally, planning illustrations based on the observed effect demonstrate how sensitive sample-size requirements can be to the effect one aims to detect. They are useful for understanding hypothetical future planning under stated assumptions, but they do not reveal the rationale for this trial’s enrollment and are not observed power. The distinction between planning quantities, observed results, and original design assumptions is central to sound statistical reading.

18. 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 registry record gives aggregated outcome summaries rather than participant-level data. It does not report the distribution of pain scores, changes over time, or the number of participants in each pain reference category. The primary outcome is an average over the stated inpatient period, so differences in individual experiences cannot be assessed from the summary alone.

Several design and analysis details are not reported in the registry record, including eligibility criteria, allocation-concealment procedures, dose information, analysis-population rules, missing-data methods, and covariate adjustment. Masking is recorded as none, which is relevant to a subjective pain outcome, but the record does not describe outcome collection procedures or establish that any bias occurred.

The original sample-size justification and statistical analysis plan are not reported. The planning illustrations use the observed effect and stated assumptions, so they cannot explain the enrollment decision. The registry record also does not report a clinically important difference threshold, leaving no trial-defined basis for judging whether the estimated difference would be meaningful to patients.

Multiple secondary outcomes are listed, but a multiplicity plan is not reported. The registry record provides no specific numerical findings for some listed outcomes, including return to activities of daily living and oral narcotic use after discharge. Safety reporting is limited to the listed counts; details about event types and follow-up are not reported in the registry record. These limitations restrict interpretation of the breadth, robustness and generalizability of the findings.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Toradol v. Celecoxib for Postoperative Pain — NCT03331315.
• Registry record last updated 2023-12-07; status last verified 2023-11.
• Results first posted 2018-06-04.
• 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.

22. Record Summary

NCT03331315 is a completed Phase 2 randomized, parallel-group trial comparing Celecoxib with Ketorolac for postoperative pain following hysterectomy. The record lists enrollment of 170 and no masking. The primary outcome is average inpatient postoperative pain score during the 48 hrs following surgery, measured using a Visual Analog Scale.

The mean score was 2.7 in the Ketorolac arm and 2.4 in the Celecoxib arm. The estimated mean difference for Celecoxib relative to Ketorolac was -0.3; the confidence interval crosses zero and the unadjusted p-value is 0.315. The comparison is uncertain and does not establish equivalence or a treatment advantage.

The registry record lists secondary outcomes and reports summaries for inpatient medication use and hospital stay. It also records adverse-event counts, with no serious adverse events listed in either arm. Details about the original sample-size justification, analysis populations, missing-data methods and multiplicity plan are not reported in the registry record.