This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old (NCT04684238), a randomized phase 3 study. The primary outcome is Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04684238 |
| Phase | Phase 3 |
| Condition | Sedation |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 94 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Sedana Medical |
| Results posted | Yes |
2. Clinical Question
Population
Mechanically ventilated paediatric patients aged 3–17 years admitted to an intensive care unit. The primary outcome analysis used the Full Analysis Set, which included randomized patients who received study medication and met the recorded sedation-period and assessment requirements.
Intervention
Inhaled isoflurane delivered through the AnaConDa-S anaesthetic conserving device for ICU sedation.
Comparator
Intravenous midazolam for ICU sedation. The trial used an active comparator rather than a no-sedation control.
Primary question
How did the groups compare in the percentage of monitored time when sedation was adequately maintained within the COMFORT-B interval prescribed at randomisation, over a minimum of 12 hours up to 48 hours with a ±6-hour window?
The clinical question is about maintaining a specified sedation depth during mechanical ventilation, not about comparing sedation with no treatment. The endpoint includes light, moderate or deep sedation when that range was the one prescribed at randomisation. Sedation was monitored every 2 hours during the assessment period.
The registry also lists secondary questions about opioid use, time from study-drug administration ending to extubation, spontaneous breathing, need for additional inotropic or vasopressor agents, withdrawal symptoms, delirium, and neurological symptoms or psychomotor dysfunction. These broaden the clinical scope, but the registry record does not report quantitative results for every listed outcome.
The primary contrast is between group-level least-squares means from a mixed models analysis. It estimates the difference in the recorded sedation-time measure under the trial analysis, rather than establishing that either sedative is better for every child or for every outcome of care.
3. Trial Design
This was a randomized, active-controlled, parallel-group phase 3 study. The registry describes the masking as single, but does not report which participants, clinicians, assessors or other study personnel were masked. The intervention groups received either inhaled isoflurane delivered by the AnaConDa-S device or intravenous midazolam for ICU sedation.
The registry lists enrollment as 94. The primary analysis reports 33 participants in the midazolam group and 59 in the isoflurane group; the adverse-event summaries use 33 and 61 participants at risk, respectively. These are outcome-specific denominators, and the registry record does not explain the differences in the isoflurane denominators. They should not be treated as interchangeable analysis populations.
The primary endpoint was assessed over a minimum of 12 hours up to 48 hours, with a ±6-hour window. The Full Analysis Set included randomized patients who received study medication, had at least a 6-hour sedation period and had at least 3 blinded COMFORT-B assessments. The record says this set followed the intention-to-treat principle, with patients analysed according to their assigned group, while also specifying these inclusion requirements.
The registry lists the study as completed. Its recorded start was 2021-01-14 and its primary completion was 2023-01-19. Further details about randomization procedures, allocation concealment, masking procedures, site structure, protocol deviations and the handling of withdrawals are not reported in the registry record. The design label alone does not establish how these procedures were carried out.
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: 96 patients were randomised in total, 2 patients randomised to isoflurane did not receive treatment and 3 patients receiving treatment did not complete (1 patient receiving isoflurane and 2 patients receiving midazolam)
Overall Study
| Stage | Drug: Midazolam | Drug: Isoflurane |
|---|---|---|
| STARTED | 33 | 61 |
| COMPLETED | 31 | 60 |
| NOT COMPLETED | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis set (FAS): The FAS included all randomised patients who received IMP and had at least a 6-hour sedation period and at least 3 blinded COMFORT-B-assessments. The FAS followed the intention-to-treat principle, i.e., patients were analysed according to the treatment group they were assigned to at randomisation. The main statistical analysis was performed on this population.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Drug: Midazolam | Drug: Isoflurane | Total |
|---|---|---|---|---|
| Participants analysed | 33 | 61 | 94 | |
| Age, Customized: Children (2-11 years) | Participants | 28 | 47 | 75 |
| Age, Customized: Adolescents (12-17 years) | Participants | 5 | 14 | 19 |
| Sex: Female, Male: Female | Participants | 13 | 23 | 36 |
| Sex: Female, Male: Male | Participants | 20 | 38 | 58 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 10 | 13 | 23 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 13 | 28 | 41 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 10 | 20 | 30 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 22 | 41 | 63 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 10 | 18 | 28 |
| Weight | kg | 26.95 (SD 19.68) | 28.83 (SD 17.25) | 28.16 (SD 18.06) |
| Height | cm | 118.3 (SD 21.5) | 125.8 (SD 26.6) | 123.2 (SD 25.1) |
| Height | cm | 112.5 (91 to 170) | 123.0 (90 to 185) | 117.0 (90 to 185) |
| Weight | kg | 21.60 (11.0 to 112.0) | 20.00 (11.8 to 90.0) | 20.00 (11.0 to 112.0) |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours), measured over Minimum of 12 hours up to 48 hours (± 6 hours)..
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Percentage of time |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the percentage of time with adequately maintained sedation depth within the COMFORT-B interval prescribed at randomisation. That interval could represent light, moderate or deep sedation. Assessments were made every 2 hours during the study’s primary assessment period, which was a minimum of 12 hours up to 48 hours with a ±6-hour window.
This measure focuses on whether sedation remained in the prescribed range over monitored time. Expressing the outcome as a percentage makes the summary reflect the share of assessed time in range rather than only a single sedation assessment. It is therefore a measure of maintenance of the targeted sedation depth, not a direct measure of comfort, recovery, ventilation duration or overall safety.
The registry reports group least-squares means with 95% confidence intervals and a mixed-model contrast. The group estimates were 62.37 for midazolam and 68.94 for isoflurane. The reported between-group contrast was 6.57, with a 95% confidence interval from -8.99 to 22.13. The interval describes uncertainty in the estimated contrast; it includes values on either side of no difference, so the posted estimate does not precisely establish the direction or size of a group difference.
The endpoint is clinically interpretable as time within the prescribed target, but its interpretation depends on how the assessment schedule, missing measurements and treatment changes were handled. Those details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary group estimates were 62.37 for midazolam and 68.94 for isoflurane. The sponsor-reported mixed-model contrast was 6.57, with a 95% confidence interval from -8.99 to 22.13. The contrast is expressed on the endpoint’s percentage-of-time scale. Its confidence interval extends from a negative estimate to a positive estimate, so the posted data are compatible with different directions of the underlying contrast as well as with little or no difference.
A confidence interval communicates the precision of an estimate under the analysis used. It is not a range that guarantees where the true effect lies, and it does not by itself establish clinical importance. The breadth and direction-crossing of this interval mean that the point estimate should not be read in isolation as a settled comparison. The registry does not report a p-value for this primary analysis.
The group means are least-squares means from a mixed models analysis, rather than simple arithmetic averages identified as such in the record. The registry does not describe the model’s covariates, covariance structure, missing-data assumptions or other implementation details. Consequently, the reported contrast should be read as the result of the stated model, not as a fully reproducible calculation from the group summaries alone.
The posted binary secondary comparisons show estimates in different directions across outcomes. The unadjusted recalculations do not establish that these patterns are reliable findings: their confidence intervals are broad and include no difference, and the registry does not report sponsor analyses for these outcomes. The secondary results are therefore exploratory context rather than a substitute for the primary comparison. They also involve different outcome definitions and analysis populations, so their estimates should not be combined into one general claim about sedation.
The adverse-event summaries describe events observed in the two groups, with different denominators from the primary outcome. They are descriptive and do not establish that a study drug caused an event or that an apparent difference is attributable to treatment. Death counts are also reported, but the registry’s listed 30 days/hospital mortality comparison is a secondary outcome and should not be mistaken for the primary efficacy endpoint.
Overall, the posted primary estimate points toward a higher in-range sedation-time measure in the isoflurane group, but the confidence interval leaves substantial uncertainty about the between-group contrast. Neither the primary result nor the secondary summaries support a definitive claim about comparative clinical benefit or harm.
9. Statistical Methods Explained
The primary outcome is continuous: it records a percentage of monitored time within the specified sedation range. For a continuous outcome, the analysis compares group summaries on a numerical scale. The registry reports least-squares means and a mixed-model comparison, rather than only presenting separate raw group averages.
What does a least-squares mean represent?
In general, a least-squares mean is a model-based estimate of a group’s mean outcome. It can account for features included in the fitted model, whereas a raw mean is calculated directly from observed values. The registry identifies the primary method as a mixed models analysis but does not report enough model detail to identify which covariates or repeated-measure structures were used. The reported least-squares means and contrast should therefore be interpreted as model-based results, with the model specification not fully described in the registry record.
How should the confidence interval be read?
The primary contrast is 6.57, with a 95% confidence interval from -8.99 to 22.13. In general, a confidence interval gives a range of estimates reasonably compatible with the observed data and the statistical model, under the method’s assumptions. A narrower interval indicates greater precision than a wider one. Here, the interval includes negative and positive values, so the estimate does not pin down the direction of the contrast. The interval is not a statement that every value inside it is equally likely, nor does it indicate the probability that a particular treatment is superior.
The interval is reported at the 95% level. No p-value is reported for the primary mixed-model comparison, so a p-value should not be inferred from the registry entry. A confidence interval and a p-value address related questions but are not interchangeable descriptions of clinical importance.
Why does the mixed-model result differ in form from the group summaries?
In general, mixed models can be used when observations have a structure such as repeated measurements within a participant. They can represent correlations among observations rather than treating every assessment as independent. That feature may be relevant when sedation is assessed repeatedly over time. However, the registry does not state the precise model structure or confirm which repeated observations entered the fitted model. The method name alone does not reveal how all data-handling choices were made.
The reported group estimates are 62.37 for midazolam and 68.94 for isoflurane, with corresponding 95% confidence intervals of 44.7 to 80.04 and 52.83 to 85.05. The registry’s model-based contrast has its own confidence interval. A contrast interval is the uncertainty estimate for the between-group comparison; it should not be reconstructed by informally comparing the separate group intervals.
What do the secondary risk differences mean?
For binary outcomes, the recalculated comparisons are expressed as risk differences: the estimated event proportion in the isoflurane group minus the corresponding proportion in the midazolam group. In general, a risk difference is an absolute-scale comparison. A positive estimate means the event proportion is higher in the first group named in that comparison; a negative estimate means it is lower. The interval indicates the uncertainty around that difference. When the interval includes zero, the data do not clearly distinguish a difference from no difference under that calculation.
The posted secondary recalculations are unadjusted. In general, an unadjusted comparison does not account for other variables unless those are explicitly built into the analysis. The registry does not report adjusted sponsor analyses for the secondary outcomes included in the recalculations. The p-values accompanying those recalculations are not adjusted for the number of outcomes or comparisons, so they should not be treated as confirmatory evidence.
What do the planning illustrations show?
Planning illustrations use an assumed effect and statistical design choices to describe the number of participants per arm that would be needed under those assumptions. They are not evidence of the trial’s achieved power, and they do not show what the trial was originally designed to detect. The posted illustrations use the observed effect or stated fractions of it, a two-sided significance level of 0.05, equal allocation and a normal approximation. They are conditional planning calculations, not observed trial results.
In general, a smaller assumed effect requires a larger sample to detect it with the same target power, because it is harder to distinguish from random variation. Such illustrations are especially sensitive to the estimate used as the starting effect. An imprecise observed effect can make a planning calculation unstable, so the illustrations should not be interpreted as a sample-size justification for this study. The trial’s own sample-size rationale is not reported in the registry record.
All of these methods depend on how outcomes and missing observations were handled. The registry supplies the primary analysis population definition and outcome timing, but fuller analysis specifications are not reported. The numerical results are consequently best read as the posted analysis outputs, alongside the uncertainty and reporting limitations, rather than as a complete account of every statistical decision.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Mixed Models Analysis | Least square means 6.57 | -8.99 to 22.13 | not reported |
The primary result is the sponsor-reported mixed models analysis: a least-squares-mean contrast of 6.57, with a 95% confidence interval from -8.99 to 22.13. The registry does not report a p-value for this analysis. The interval crosses zero, indicating that the reported estimate is not precise enough to determine the direction of the contrast.
The registry record contains no discrepancy flag for the primary result, and the sponsor’s analysis takes precedence over any simple recalculation from the posted group summaries. The group estimates and the mixed-model contrast are not interchangeable: the former are model-based estimates for each group, while the latter is the reported between-group analysis. Reconstructing a contrast from rounded summaries would not reproduce the fitted model.
For the posted secondary outcomes, the recalculated comparisons are simple, unadjusted comparisons based on the reported summary counts. The registry does not report sponsor analyses for those outcomes. These recalculations are useful for describing the direction and uncertainty of the posted counts, but they are not substitutes for a prespecified or adjusted sponsor analysis. The record does not report whether a fuller analysis plan specified other methods for those outcomes.
11. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a multiplicity-control procedure for the primary and secondary outcomes. This matters because evaluating many outcomes can increase the chance of observing apparently notable results through random variation. The posted unadjusted secondary comparisons do not account for the number of comparisons, and their p-values should not be read as if they came from a single, prespecified test. The registry record does not report whether the sponsor used a hierarchy, adjusted testing procedure or other strategy in a fuller analysis plan.
The record lists a Full Analysis Set for the primary endpoint. It includes randomized patients who received study medication, had at least a 6-hour sedation period and had at least 3 blinded COMFORT-B assessments. The record says the set followed the intention-to-treat principle and that patients were analysed according to their assigned group. Because inclusion also required receipt of study medication and specified post-randomization assessment conditions, readers should retain both parts of that definition rather than assume that every randomized patient entered the primary analysis.
How missing primary assessments were handled is not reported in the registry record. The record does not state whether missing observations were imputed, excluded from particular calculations, or handled through assumptions in the mixed model. The number and reasons for missing assessments are not reported. The handling of missing data for the secondary outcomes is also not reported.
The registry does not report interim analyses, stopping rules, the sample-size justification or the full statistical analysis plan. It also does not explain all differences between the analysis denominators for the primary outcome and the adverse-event summaries. These omissions limit independent evaluation of prespecification and of how analysis decisions may have affected precision or interpretation. They do not establish that any particular procedure was or was not used; those details are simply not reported in the registry record.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Drug: Midazolam | 8 | 33 | 24.2% |
| Drug: Isoflurane | 19 | 61 | 31.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Drug: Midazolam | 2 of 33 |
| Drug: Isoflurane | 1 of 61 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Drug: Midazolam | 13 of 33 |
| Drug: Isoflurane | 32 of 61 |
Most frequent serious adverse event terms
| Event term | Organ system | Drug: Midazolam | Drug: Isoflurane |
|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | 0 of 33 | 3 of 61 |
| Septic shock | General disorders | 2 of 33 | 0 of 61 |
| Magnetic resonance imaging head abnormal | Investigations | 0 of 33 | 1 of 61 |
| Anaesthetic complication neurological | Injury, poisoning and procedural complications | 0 of 33 | 1 of 61 |
| Complications of transplanted liver subjects affected / exposed | Injury, poisoning and procedural complications | 1 of 33 | 0 of 61 |
| Gastrostomy tube site complication | Injury, poisoning and procedural complications | 0 of 33 | 1 of 61 |
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | 1 of 33 | 0 of 61 |
| Postpericardiotomy syndrome | Injury, poisoning and procedural complications | 1 of 33 | 0 of 61 |
| Hypotension | Vascular disorders | 0 of 33 | 1 of 61 |
| Shock haemorrhagic | Vascular disorders | 0 of 33 | 1 of 61 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Drug: Midazolam | Drug: Isoflurane |
|---|---|---|---|
| Constipation | Gastrointestinal disorders | 4 of 33 | 12 of 61 |
| Pyrexia | General disorders | 2 of 33 | 8 of 61 |
| Pleural effusion | General disorders | 1 of 33 | 5 of 61 |
| Delirium | Psychiatric disorders | 1 of 33 | 5 of 61 |
| Bradycardia | Cardiac disorders | 3 of 33 | 3 of 61 |
| Hypoxia | General disorders | 1 of 33 | 4 of 61 |
| Tachycardia | Cardiac disorders | 0 of 33 | 4 of 61 |
| Hyperthermia | General disorders | 2 of 33 | 1 of 61 |
| Pruritus | Skin and subcutaneous tissue disorders | 2 of 33 | 0 of 61 |
Serious events with the highest arm-level rate: septic shock (6.1%), acute kidney injury (4.9%), complications of transplanted liver subjects affected / exposed (3.0%), postoperative thoracic procedure complication (3.0%), postpericardiotomy syndrome (3.0%).
The adverse-event summary reports serious adverse events among 8 of 33 participants at risk in the midazolam group and 19 of 61 at risk in the isoflurane group. Other adverse events were reported for 13 of 33 and 32 of 61, respectively. The registry reports deaths for 2 participants in the midazolam group and 1 participant in the isoflurane group. These are descriptive counts, not estimates that establish a treatment-caused difference.
The registry lists septic shock at 6.1%, acute kidney injury at 4.9%, complications of transplanted liver subjects affected / exposed at 3.0%, postoperative thoracic procedure complication at 3.0%, postpericardiotomy syndrome at 3.0%, and cerebrovascular accident at 3.0% among the top serious-event terms. These categories describe reported events; the registry summary does not establish their cause or provide enough context to compare event severity or relatedness between groups.
The adverse-event denominators differ from the primary outcome’s group sizes, and the registry record does not explain that difference. The counts should be interpreted within their stated at-risk groups and should not be combined with the primary analysis. The available summaries do not establish comparative safety.
13. What the Result Does, and Does Not, Mean
The primary result describes a model-based comparison of the percentage of monitored time in the prescribed sedation range. The isoflurane group estimate was 68.94 and the midazolam group estimate was 62.37. The reported contrast was 6.57, with a 95% confidence interval from -8.99 to 22.13. These values describe the posted result and its uncertainty; they do not establish a definite difference between the groups.
The result does not show that either sedative works or fails to work. Both groups received active sedation, and the endpoint evaluates maintenance of a prescribed sedation depth within the trial’s observation period. It does not directly answer questions about every clinical outcome, longer-term recovery or the comparative merits of the treatments in settings outside the trial population.
The primary confidence interval includes estimates in both directions. The point estimate alone should not be used to claim that isoflurane produced better sedation maintenance, and the interval should not be interpreted as proof that the treatments are equivalent. A finding of equivalence or non-inferiority would require an appropriate design, a prespecified margin and the corresponding analysis; these are not reported in the registry record.
The secondary outcomes and adverse-event counts do not remove this uncertainty. They are distinct measures, include unadjusted recalculations, and have their own limitations in reporting and precision. They can help frame questions for further study, but they do not convert the primary estimate into a definitive clinical conclusion.
In general, statistical uncertainty is only one part of interpretation. Clinical importance depends on the outcome’s meaning, the size of differences considered important, and the study’s methods and population. The registry record does not report a threshold for a clinically important difference in the primary endpoint. Accordingly, the posted data support a cautious description of the observed estimates, not medical advice or a treatment recommendation.
14. Why This Trial Matters Statistically
This trial raises a useful statistical question about how to compare sedation strategies when the target is a range of sedation depth maintained over time. The primary endpoint turns repeated assessments into a percentage of monitored time in range, making the outcome more informative than a single measurement for the specific question of target maintenance. The mixed-model result also illustrates why the reported between-group contrast and its confidence interval deserve more attention than the point estimate alone.
The contrast of 6.57 has a 95% confidence interval from -8.99 to 22.13. That interval communicates substantial uncertainty about the direction and size of the comparison. It is a practical example of why a numerical difference between group estimates does not, by itself, establish a reliable treatment difference. Interpretation also depends on the analysis population and model, details of which are only partly described in the registry record.
The trial also demonstrates the distinction between primary and secondary evidence. Secondary outcomes may be clinically relevant, but numerous unadjusted comparisons can produce mixed patterns that are difficult to interpret as confirmatory. Results with different definitions and timeframes should not be collapsed into a single overall conclusion. Clear reporting of prespecified priorities and multiplicity handling would help readers judge their evidential role.
Finally, a registry summary allows readers to see both reported results and important gaps. Here, the primary analysis is identified, while fuller details about missing-data handling, model specification, multiplicity and the sample-size rationale are not reported in the registry record. Recognizing those limits is part of sound statistical interpretation, not a reason to overstate what the available estimates show.
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.
Several limitations specific to this trial affect interpretation of the posted results. The primary analysis used a defined Full Analysis Set rather than describing the analysis population as every randomized participant without qualification. Eligibility for that set required receipt of study medication, a minimum sedation period and a minimum number of blinded COMFORT-B assessments. The registry does not report how many randomized patients were excluded from this endpoint analysis or why.
The primary result comes from a mixed models analysis, but the registry record does not describe the model specification, covariates, repeated-measure structure or assumptions about missing observations. The method name is not enough to reproduce the analysis. The record also does not report the number or pattern of missing assessments, or how missing data were handled.
The outcome-specific denominators vary: the primary result reports 33 participants in the midazolam group and 59 in the isoflurane group, while adverse-event summaries use 33 and 61 participants at risk. The registry does not explain these differences. This limits direct comparisons across outcome summaries and makes it important to retain each outcome’s stated denominator.
Masking is described as single, but the registry does not identify who was masked or how masking was maintained. Details about allocation concealment, deviations from assigned treatment and the handling of treatment changes are not reported in the registry record. The sponsor’s sample-size justification and any interim analyses are also not reported.
Secondary recalculations are unadjusted and lack reported sponsor analyses. The registry record does not report a multiplicity strategy or the full analysis plan. The available secondary results therefore have limited confirmatory value, while the primary confidence interval itself remains compatible with estimates on either side of no difference. These reporting gaps restrict how far conclusions can be generalized beyond the posted estimates.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old — NCT04684238.
- Registry record last updated 2025-05-25; status last verified 2025-05.
- Results first posted 2025-05-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT04684238 is a completed, randomized, parallel-group phase 3 study comparing inhaled isoflurane delivered by the AnaConDa-S device with intravenous midazolam for sedation in mechanically ventilated children aged 3–17 years. The registry lists enrollment as 94 and describes masking as single.
The primary endpoint was the percentage of time within the prescribed COMFORT-B sedation range during a minimum of 12 hours up to 48 hours, with a ±6-hour window. The reported mixed-model contrast was 6.57, with a 95% confidence interval from -8.99 to 22.13. The interval includes values in both directions, leaving uncertainty about the between-group difference.
Secondary outcome summaries and adverse-event counts provide additional descriptive information, but the registry record does not report sponsor analyses for the posted secondary comparisons or a multiplicity-control procedure. Further details about model specification, missing-data handling and the study’s sample-size rationale are not reported in the registry record.