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Comparison · NCT04684238-5b6a9900

Drug: Midazolam vs Drug: Isoflurane: Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Drug: Midazolam vs Drug: Isoflurane: Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction. Trial comparisons, record NCT04684238-5b6a9900. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04684238-5b6a9900

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1820.08610.344wilson
Risk in group 20.2620.1680.384wilson
Risk difference, group 1 minus group 2-0.0805-0.2360.107newcombe hybrid score
Risk ratio, group 1 over group 20.6930.31.6log
Odds ratio, group 1 over group 20.6250.2181.79log
Number needed to treat, for one fewer participant with the outcome on Drug: Midazolam than on Drug: Isoflurane12.4from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Drug: MidazolamMidazolam for sedation in the ICU~Midazolam: Solution for Injection/Infusion633OG000
Group 2Drug: IsofluraneVolatile for sedation in the ICU~Isoflurane: Inhalation vapour, liquid. Isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device)1661OG001

Outcome

Type
SECONDARY
Title
Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction
Description
Evaluate the frequency of neurological symptoms or psychomotor dysfunction during and up to 48 hours after discontinuation of isoflurane and midazolam treatment, and the association with duration of treatment, and total exposure (MAC hours and midazolam doses) over time.
Time frame
During study treatment and up to 48 hours after discontinuation of isoflurane and midazolam
Population

Source ClinicalTrials.gov

Trial

Title
Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
NCT number
NCT04684238
Phases
PHASE3
Conditions
Sedation
Interventions
Midazolam, Isoflurane
Lead sponsor
Sedana Medical
Results first posted
2025-05-25

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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