Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery (NCT03062488), a randomized early/phase 1 study. The primary outcome is Emergence Agitation (EA) as Measured by Standardized PAED Scale.

2. Clinical Question

The clinical question concerns children recovering from routine ENT surgery after sevoflurane anesthesia. It asks whether the recorded emergence-agitation scores differ when fentanyl is given alone or with acetaminophen by either route. Post-operative pain and fentanyl consumption are also listed as secondary outcomes. The registry says recovery staff assessed pain using FLACC Score or Wong-Baker FACES for patients 24 months up to 7 years of age, and Numeric Pain Score for patients 7 years of age. The pre-operative, surgery, anesthesia, and post-operative staff are described as blinded. The record does not report detailed age eligibility, the distribution of ages, or the extent to which each pain measure was used in each group.

3. Trial Design

The registry describes a randomized, parallel-group study with triple masking. Its official title calls the study multi-center and double-blinded. These are the descriptions in the record; further details explaining the masking labels or the participating centers are not reported in the registry record. The study is listed as completed, with enrollment of 143.

The three groups were opioid only, opioid plus PO analgesic, and opioid plus IV acetaminophen. The opioid-only regimen was 2 mcg/Kg of fentanyl. The PO group received that fentanyl regimen plus PO acetaminophen 15 mg/Kg; the IV group received that fentanyl regimen plus 15mg/Kg of IV acetaminophen. Arm-level primary outcome results list 51 participants for opioid only, 51 for opioid plus PO analgesic, and 41 for opioid plus IV acetaminophen. The reason for the difference in the listed arm sizes is not reported in the registry record.

The primary outcome was mean emergence agitation measured with the PAED scale during the first 60 minutes of recovery after anesthesia. The registry defines EA as a PAED score equal to or greater than 12, while the posted primary outcome results are continuous scores. Secondary outcomes were post-operative pain and post-operative fentanyl consumption. The study dates are listed as 2017-10-03 for start and 2018-07-11 for primary completion.

The registry classifies the study phase as EARLY PHASE1. Its original sample-size justification, detailed protocol, allocation-concealment procedure, and analysis plan are not reported in the registry record. The listed trial design therefore establishes the broad comparison and masking description, but does not establish how every operational or statistical decision was made.

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.

Before assignment: No events. Patients were screened prior to pre-enrollment.

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 Emergence Agitation (EA) as Measured by Standardized PAED Scale, measured over first 60 minutes of recovery post anesthesia.

The primary endpoint is mean score on the Pediatric Anesthesia Emergence Delirium scale during the first 60 minutes of recovery after anesthesia. The registry describes the PAED scale as ranging from 0 to 20 and defines emergence agitation as a score equal to or greater than 12. The scale gives a standardized way to quantify observed behavior during emergence from anesthesia, allowing the study to summarize scores across participants and compare group means.

A mean score answers a different question from the incidence of EA. A mean describes the average score in a group; an incidence measure would count or report the proportion of participants who met the specified threshold. Although the study summary says incidence was an aim, the posted primary results give group means and standard deviations. Counts meeting the PAED threshold are not reported in the registry record. Therefore the posted primary outcome can be interpreted as a comparison of average PAED scores, but it cannot establish from these results how often participants crossed the stated threshold.

The registry’s use of a standardized measure is relevant because the endpoint is an observed behavioral score rather than a direct measure of a single biological quantity. The scale definition and recovery timeframe make the intended construct and observation window clear. However, the record does not report additional information about scoring procedures, assessment schedules within the recovery window, or how scores were handled if an assessment was unavailable.

7. Results Posted in the Registry

• Opioid Plus PO Analgesic: mean 4.99 versus 5.30 on control; difference -0.31 (95% CI -1.35 to 0.73), standardized effect d = -0.12; z-test p = 0.560.
• Opioid Plus IV Acetaminophen: mean 6.29 versus 5.30 on control; difference 0.99 (95% CI -0.17 to 2.15), standardized effect d = 0.35; z-test p = 0.094.

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.

Post Operative Pain

• 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:
  • Opioid Plus PO Analgesic: mean 2.56 versus 2.58 on control; difference -0.02 (95% CI -0.69 to 0.65), standardized effect d = -0.01; z-test p = 0.954.
  • Opioid Plus IV Acetaminophen: mean 2.51 versus 2.58 on control; difference -0.07 (95% CI -0.83 to 0.69), standardized effect d = -0.04; z-test p = 0.856.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Opioid Plus PO Analgesic and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Opioid Plus IV Acetaminophen and the control. The interval gives the range of effects that remain compatible with the data.

Post Operative Fentanyl Consumption

• 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:
  • Opioid Plus PO Analgesic: mean 0.72 versus 0.64 on control; difference 0.08 (95% CI -0.14 to 0.30), standardized effect d = 0.14; z-test p = 0.469.
  • Opioid Plus IV Acetaminophen: mean 0.58 versus 0.64 on control; difference -0.06 (95% CI -0.27 to 0.15), standardized effect d = -0.12; z-test p = 0.576.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Opioid Plus PO Analgesic and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Opioid Plus IV Acetaminophen and the control. The interval gives the range of effects that remain compatible with the data.

The two secondary outcomes are post-operative pain and post-operative fentanyl consumption. Across the three groups, the posted pain means are close to one another, and the fentanyl-consumption means also remain in a relatively similar range. The unadjusted comparisons for these outcomes have confidence intervals that include zero. Taken together, the secondary summaries do not present a consistent pattern of clearly separated group averages.

This broad pattern is compatible with the primary result in one important respect: the posted group comparisons do not precisely establish a difference between either acetaminophen regimen and opioid only. The outcomes are distinct, however. PAED scores assess emergence agitation, pain scores assess post-operative pain, and fentanyl consumption describes medication use in recovery. Similar patterns across these outcomes do not make them interchangeable and do not answer the primary incidence question.

The registry lists two secondary outcomes but no reported analyses for them. The recalculated contrasts are unadjusted. When several outcomes and comparisons are examined, the chance of finding an apparently notable result by chance can increase. The record does not report a plan for controlling that multiplicity. For this reason, secondary comparisons carry less weight than a prespecified primary analysis would, and they are better treated as descriptive than confirmatory.

There is also no reported information on how the pain scales were combined across the age ranges, whether all participants contributed to each secondary outcome, or how missing measurements were handled. The registry describes different pain instruments for different ages, which is relevant context for interpreting an average across participants. Without further analysis details, the secondary results can indicate the overall pattern in the posted summaries but cannot establish comparability of measurement across all participants or resolve the primary study question.

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

• Post Operative Pain
• Post Operative Fentanyl Consumption

9. Statistical Interpretation

10. Statistical Methods Explained

The registry reports continuous outcomes as group means and standard deviations. A mean is the arithmetic average of observed scores, while a standard deviation describes how spread out scores are around that average. These summaries help distinguish the location of each group’s scores from their variability. A group mean alone does not describe the full distribution or show how many participants had scores above a particular threshold.

What does a mean difference represent?

The primary comparisons use opioid only as the reference group. A mean difference is the difference between the average score in an acetaminophen group and the average score in the opioid-only group. A negative estimate indicates a lower observed mean in the acetaminophen group; a positive estimate indicates a higher observed mean. The estimates of -0.31 for PO analgesic and 0.99 for IV acetaminophen describe the posted group summaries. They are not adjusted for other factors, because the registry does not report adjusted results.

How should uncertainty be read?

A confidence interval describes a range of values compatible with the estimate under the statistical procedure used to construct it. It communicates uncertainty more directly than a point estimate by itself. When an interval includes zero for a mean difference, the data are compatible with no average difference as well as with differences in either direction within the interval. This does not prove that the groups are identical. The confidence intervals for both primary contrasts include zero.

The posted comparison figures are unadjusted recalculations from the group-level means, standard deviations, and sample sizes. They are not listed as reported analyses in the registry. The registry does not report the investigators’ inferential method, adjustment strategy, or analysis population for these outcomes. Thus, the recalculated p values and intervals are useful descriptions of the available summaries, but they should not be attributed to a trial analysis plan that is not documented in the registry record.

What does a p value add?

A p value summarizes how unusual a result at least as inconsistent with a null hypothesis would be under a specified statistical model, assuming the null hypothesis and model are correct. It is not the probability that the null hypothesis is true, and it does not measure clinical importance. The unadjusted p values are 0.56 for PO analgesic versus opioid only and 0.094 for IV acetaminophen versus opioid only. Because the registry does not report its own analysis method or testing threshold, those recalculated values should be read alongside the estimates and confidence intervals, not as a complete account of the trial’s inferential conclusions.

Why can variation matter?

When individual scores vary substantially within a group, a group mean is estimated with less precision than it would be if scores were tightly clustered, all else being equal. Standard deviations in the primary groups range from 2.6 to 2.85. The trial’s listed arm sizes are also modest relative to some of the planning illustrations described for these observed effects. These features help explain why an estimate can be centered near zero yet still have an interval spanning values in both directions. General statistical principle: greater variability and fewer observations tend to widen uncertainty around a mean difference.

The PAED measure is bounded from 0 to 20, but the registry’s posted summaries treat it as a continuous score and report means and standard deviations. General statistical principle: bounded or skewed outcome distributions can affect how well methods based on continuous, approximately normal behavior describe the data. The registry does not report distributional checks, transformations, or alternative analyses. It is therefore not possible to determine whether such features were assessed in the original analysis.

What is multiplicity?

Multiplicity arises when several outcomes or comparisons are assessed, because repeated testing can increase the chance of at least one apparently unusual result. This study lists a primary outcome and two secondary outcomes, and each is compared across treatment groups in the recalculations. The registry does not report whether a multiplicity strategy was prespecified or used. The secondary results are therefore best treated as descriptive and exploratory rather than as independent confirmatory evidence.

These methods explanations distinguish the information contained in the posted summaries from information that would require participant-level data or a documented analysis plan. General statistical concepts describe how to read estimates and uncertainty; they do not fill gaps in the registry record about the original analysis.

11. Confidence Intervals and Precision

Precision concerns how narrowly the data locate an estimated difference. The primary mean difference for PO analgesic versus opioid only is -0.31, and its confidence interval includes zero. The difference for IV acetaminophen versus opioid only is 0.99, and its confidence interval also includes zero. In both comparisons, the intervals allow values on either side of no difference. The interval for the IV comparison extends to a larger positive value than its point estimate, while still including zero; the PO comparison likewise permits effects in either direction.

The intervals are important because the point estimates alone can invite over-interpretation. The PO estimate is close to zero, but that does not establish equivalence. The IV estimate is positive, but it does not by itself establish a higher mean in the population. The uncertainty reflected in each interval is substantial relative to the corresponding estimate.

The p values provide another summary of uncertainty under the recalculation’s assumptions, but they do not replace the intervals. The unadjusted p value is 0.56 for PO analgesic and 0.094 for IV acetaminophen. The registry does not report a prespecified threshold for interpreting these tests, nor does it provide a clinically important difference threshold for the PAED scale. Statistical evidence and clinical importance therefore cannot be collapsed into a single judgment from these figures.

Precision is limited to the continuous mean-score question. The record does not report confidence intervals for the incidence of participants reaching the PAED threshold, and the threshold counts themselves are not reported. Consequently, precision for the incidence question cannot be assessed from the posted results. The primary comparisons should be read as uncertain estimates of average scores, not as precise estimates of the frequency of emergence agitation.

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

The 80% power column represents a planning target: under the stated assumptions and a chosen effect size, a design of that size would have an 80% chance of detecting an effect at the specified significance level if the assumptions and effect were correct. The 90% power column uses a higher chance of detection as its planning target. These percentages describe hypothetical repeated-study performance under assumptions; they do not say whether the completed trial did or did not detect an effect. This is not observed power.

The rows use 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. The smaller the effect a future study aims to detect, the more participants it generally needs, because a smaller signal is harder to distinguish from random variation. For example, the planning figures for the primary PO comparison rise from 1,179 participants per arm at 100% of the observed effect to 4,716 participants per arm at 50% of the observed effect for the 80% planning target. For the primary IV comparison, the corresponding figures are 127 and 505 participants per arm. These are illustrations tied to the observed estimates, not recommendations or evidence about the original trial’s planning.

The illustrations concern one two-arm comparison at a time. They do not incorporate any unreported multiplicity adjustment, loss to follow-up assumption, or alternative outcome model. The registry does not report whether the original design used these assumptions or how its target enrollment was chosen. Because the observed effects themselves are uncertain, planning directly from them can be unstable; the figures are best read as sensitivity illustrations showing how the assumed effect changes the required size.

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 = -0.310; pooled standard deviation σ = 2.686.
2. n = 2 × (1.96 + 0.842)² × 2.686² / -0.310² = 1,178.8, rounded up to 1,179 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 <- -0.31                      # observed difference in means
sigma <- 2.68634510068978                     # 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(3062488)
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 = 1,179 (80% power), 1,579 (90% power)
 75% of observed effect: n per arm = 2,096 (80% power), 2,806 (90% power)
 50% of observed effect: n per arm = 4,716 (80% power), 6,313 (90% power)
power.t.test: 1179.8 
Simulated power at n = 1,179 per arm: 0.797 (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 identifies a primary endpoint and two secondary outcomes, with comparisons of each acetaminophen regimen against opioid only. Multiple outcomes and comparisons create a multiplicity issue: if many hypotheses are tested, some results may appear unusual by chance even when there is no underlying effect. The registry does not report whether the investigators prespecified a hierarchy, adjusted the significance threshold, or otherwise accounted for multiple testing. No multiplicity strategy should therefore be assumed.

The registry reports zero analyses in its analysis listing, and the secondary outcomes have no reported analyses. The comparisons described in this statistical account are unadjusted recalculations from arm-level summaries. The registry does not report a primary analysis model, covariate adjustment, handling of repeated measurements, or whether the analysis followed intention-to-treat or another population definition. The number and characteristics of participants included in each analysis beyond the posted arm summaries are not reported in the registry record.

Missing-data handling is also not reported in the registry record. It is not stated whether any outcome measurements were missing, how incomplete assessments were treated, or whether any imputation was performed. The arm-level sample sizes are reported for the posted outcomes, but the record does not explain whether those counts reflect all randomized participants or only those with available outcome data. This matters because missingness can affect both the precision and the interpretation of a comparison.

The registry record does not report whether there were interim analyses, subgroup analyses, or sensitivity analyses. It also does not report an adjustment strategy for the different pain measures used by age. These gaps do not invalidate the posted summaries, but they limit the ability to reconstruct the original statistical analysis or assess how robust its conclusions might be. The appropriate reading is to distinguish the registry’s posted descriptive results and unadjusted recalculations from any unreported analysis choices.

15. 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 0% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse event figures list zero affected participants in each of the three groups, and deaths are listed as zero in each group. These entries describe what is reported for the groups in the registry record. They do not provide detailed event terms, timing, severity criteria, or a narrative account of safety monitoring. The registry lists no serious adverse event terms.

Other adverse events are reported for 13 participants in the opioid-only group, 17 in the opioid plus PO analgesic group, and 15 in the opioid plus IV acetaminophen group. These are counts of affected participants in the listed groups. The registry does not report the event types or whether participants could have experienced more than one event. The figures should not be interpreted as establishing a difference in safety between groups, particularly without event detail, a prespecified safety analysis, or uncertainty estimates.

These safety entries are a descriptive part of the registry record. They do not establish that no unreported events occurred, and they do not replace a clinical assessment of the specific adverse events. No treatment recommendation follows from these counts.

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

The posted primary results show mean PAED scores of 5.3 for opioid only, 4.99 for opioid plus PO analgesic, and 6.29 for opioid plus IV acetaminophen. The recalculated unadjusted contrasts have confidence intervals that include zero. This means the available summaries do not precisely distinguish either acetaminophen group’s average score from the opioid-only group. It does not establish that the regimens are equivalent, nor does it establish that one produces a higher or lower mean in the population.

The study summary describes an interest in emergence-agitation incidence and defines EA using a PAED score equal to or greater than 12. But the posted primary results are continuous means and standard deviations. Without counts above the threshold, the frequency of threshold-defined emergence agitation cannot be determined from these results. A mean score can be similar between groups even if the distributions or threshold frequencies differ; that is a general statistical point, not a finding about these data.

Secondary summaries concern post-operative pain and fentanyl consumption. Their broad pattern does not resolve the primary uncertainty, and the registry does not report a multiplicity plan or the original analysis methods. No clinically important difference threshold is reported for the primary measure. Consequently, statistical estimates cannot be translated into a claim about whether any observed difference matters clinically.

The results also apply to the population and setting described in the registry: pediatric patients having routine ENT surgery under sevoflurane anesthesia, with the listed fentanyl and acetaminophen regimens. The record does not provide enough detail to determine how well the findings generalize to other procedures, settings, or patient groups. These limitations call for a narrow interpretation of what the registry shows, rather than a broad claim about analgesia or treatment effectiveness.

17. Why This Trial Matters Statistically

This trial is statistically informative as an example of why a point estimate should be read together with its uncertainty. The PO mean difference is -0.31 and the IV mean difference is 0.99, but both confidence intervals include zero. The observed direction of an estimate is not, on its own, evidence that the same direction would persist in a broader population. Precision and interval width matter, especially when group sizes and outcome variability leave substantial uncertainty.

It also illustrates the distinction between a continuous score and a threshold-defined event. The registry defines emergence agitation using a PAED cutoff, yet the posted results summarize means. Those summaries answer a question about average score, not incidence above the cutoff. Matching the reported result to the endpoint actually measured and posted is essential to avoid overstating what can be concluded.

The secondary outcomes demonstrate another common issue: several outcomes can be measured in the same trial, but unadjusted comparisons across them do not automatically provide independent confirmation. Without a reported multiplicity strategy or analysis plan, secondary findings require cautious interpretation. The registry’s lack of reported analyses also makes it important to separate recalculated descriptive comparisons from the investigators’ original inferential conclusions.

Finally, the planning illustrations show how sample-size requirements depend on the effect a future study aims to detect. Smaller assumed effects require more participants under the listed assumptions. These planning figures are not evidence about the completed study’s power or its design rationale. The distinction between prospective planning and retrospective summaries is central to sound interpretation of trial statistics.

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 provides arm-level means, standard deviations, and sample sizes, but does not report participant-level data or detailed distributions. It therefore does not allow assessment of skewness, outliers, or how the PAED scores were distributed within each group. The primary outcome is posted as a continuous mean even though the study summary emphasizes incidence using a threshold; threshold counts are not reported.

Detailed eligibility criteria, age distribution, and the number of participants contributing to each outcome are not reported in the registry record. Pain measurement used different instruments according to the ages described in the summary, and the record does not explain how those instrument scores were harmonized or compared. The reasons for the differing arm sizes are also not reported.

The registry does not report the original statistical analysis plan, the sample-size justification, analysis populations, missing-data methods, covariate adjustment, or multiplicity handling. It also provides no reported analyses for the secondary outcomes. The recalculations are unadjusted and based on summary statistics; they cannot reproduce any analysis that might have used individual data or additional covariates.

Safety reporting is limited to counts of affected participants and deaths, without serious-event terms or details of other events. The registry’s description of triple masking and the official title’s double-blinded wording are not accompanied by further procedural explanation. These record-specific limitations restrict detailed evaluation of design implementation, endpoint ascertainment, and robustness of the results.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery — NCT03062488.
• Registry record last updated 2020-01-18; status last verified 2017-08.
• Results first posted 2020-01-18.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT03062488 is a completed randomized parallel-group study of analgesia for pediatric routine ENT surgery under sevoflurane anesthesia. The registry lists enrollment of 143 and compares fentanyl alone with fentanyl plus PO acetaminophen or fentanyl plus IV acetaminophen. The primary outcome is mean PAED score during the first 60 minutes of recovery; the registry defines emergence agitation as a score equal to or greater than 12.

The posted primary means are 5.3 for opioid only, 4.99 for opioid plus PO analgesic, and 6.29 for opioid plus IV acetaminophen. Both unadjusted recalculated mean-difference intervals include zero. Threshold incidence counts are not reported in the registry record. Post-operative pain and fentanyl consumption are listed as secondary outcomes, with no reported analyses. The original analysis plan, sample-size justification, missing-data methods, and multiplicity strategy are not reported in the registry record.