Trial · NCT04684238
Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
NCT04684238, Phase 3, Completed, Sedana Medical; results first posted 2025-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old. Trials, record NCT04684238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04684238
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
- NCT number
- NCT04684238
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 94 participants, actual
- Lead sponsor
- Sedana Medical
- Conditions
- Sedation
- Interventions
- Midazolam, Isoflurane
- First posted
- 2020-12-24
- Last updated
- 2025-05-25
- Results first posted
- 2025-05-25
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Minimum of 12 hours up to 48 hours (± 6 hours). | Percentage of time of adequately maintained sedation within the COMFORT-B interval (light, moderate or deep sedation) prescribed at randomisation, monitored every 2 h for a minimum of 12 h (up to 48 h ± 6 h) |
| Secondary | Compare the Use of Opioids | From first blinded COMFORT-B assessment (at +2 h from start of study drug initiation) to end of the study treatment period | Dose of opioids from first blinded COMFORT-B assessment (at +2 h from start of study drug) to end of study treatment period. This was a key secondary efficacy endpoint. Dose of opioids was expressed as fentanyl IV equivalents. |
| Secondary | Compare the Use of Opioids | Last 4 hours of study treatment compared to first 4 hours of study treatment after first blinded COMFORT-B assessment (at +2 h from start of study drug initiation). | Dose of opioids during the last 4 h of study treatment, as compared to the first 4 h of study treatment after first blinded COMFORT-B assessment. This was a key secondary efficacy endpoint. Dose of opioids is expressed as fentanyl IV equivalents. |
| Secondary | Compare Time From End of Study Drug Administration to Extubation | From end of study drug administration to extubation or end of extubation attempt | Time from end of study drug administration to extubation if study drug was terminated for extubation |
| Secondary | Compare the Proportion of Time With Spontaneous Breathing | From initiation of study drug treatment to End of study treatment (up to 48h +/- 6h) | Proportion of observations with spontaneous breathing efforts during study treatment. This was a key secondary safety endpoint. |
| Secondary | Evaluate Haemodynamic Effect as Indicated by Need for Additional Inotropic/Vasopressor Agent | From start of study treatment to end of study treatment (up to 48h +/- 6h) | Need for additional inotropic/vasopressor agent defined by change in Vasoactive-Inotropic Score (VIS) during study treatment period compared to baseline. The VIS quantifies the amount of cardiovascular support required by infants postoperatively according to the below calculation: VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (U/kg/min). An increased VIS score correlates to an increase in inotropic/vasopressor agents. |
| Secondary | Evaluate the Number of Patients With Withdrawal Symptom | From > 96 hours sedation (including pre-study sedation period) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. | Evaluate the frequency of withdrawal symptoms in isoflurane- vs midazolam-treated patients according to SOS-PD. |
| Secondary | Evaluate the Frequency of Delirium | Patients admitted to the ICU ≥48 hours (including period prior to study enrolment) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. | Evaluate the frequency of delirium in isoflurane- vs midazolam-treated patients |
| Secondary | Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction | During study treatment and up to 48 hours after discontinuation of isoflurane and midazolam | 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. |
| Secondary | Compare the 30 Days/Hospital Mortality | From start of study treatment up to 30 days | Compare the 30 days/hospital mortality in isoflurane- vs midazolam-treated patients |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Minimum of 12 hours up to 48 hours (± 6 hours). | 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. | Percentage of time | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Minimum of 12 hours up to 48 hours (± 6 hours). | The PP analysis set included all patients in the FAS without any major protocol deviation affecting the primary analysis. To be included in the PP analysis patients had to have been sedated for at least 12h (which was interpreted as 12 h of study sedative treatment from start of IMP), with at least 50% of the planned COMFORT-B assessments performed. | Percentage of time | LEAST_SQUARES_MEAN |
| SECONDARY | Compare the Use of Opioids | From first blinded COMFORT-B assessment (at +2 h from start of study drug initiation) to end of the study treatment period | 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 (ITT) principle, i.e., patients were analysed according to the treatment group they were assigned to at randomisation. | μg/kg/h | LEAST_SQUARES_MEAN |
| SECONDARY | Compare the Use of Opioids | Last 4 hours of study treatment compared to first 4 hours of study treatment after first blinded COMFORT-B assessment (at +2 h from start of study drug initiation). | FAS: Patients with 8 hours or more of study treatment from first blinded COMFORT-B assessment. | μg/kg/h | LEAST_SQUARES_MEAN |
| SECONDARY | Compare Time From End of Study Drug Administration to Extubation | From end of study drug administration to extubation or end of extubation attempt | Subgroup of patients with endotracheal tube where wake-up was initiated at end of study treatment | hour | MEAN |
| SECONDARY | Compare the Proportion of Time With Spontaneous Breathing | From initiation of study drug treatment to End of study treatment (up to 48h +/- 6h) | Full Analysis Set | proportion of time | LEAST_SQUARES_MEAN |
| SECONDARY | Evaluate Haemodynamic Effect as Indicated by Need for Additional Inotropic/Vasopressor Agent | From start of study treatment to end of study treatment (up to 48h +/- 6h) | Safety analysis set | Change from baseline in VIS | MEAN |
| SECONDARY | Evaluate the Number of Patients With Withdrawal Symptom | From > 96 hours sedation (including pre-study sedation period) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Evaluate the Frequency of Delirium | Patients admitted to the ICU ≥48 hours (including period prior to study enrolment) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction | During study treatment and up to 48 hours after discontinuation of isoflurane and midazolam | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Drug: Midazolam | 62.37 | 95% Confidence Interval 44.70 to 80.04 | Percentage of time | |
| Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Drug: Isoflurane | 68.94 | 95% Confidence Interval 52.83 to 85.05 | Percentage of time | |
| Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Drug: Midazolam | 65.57 | 95% Confidence Interval 44.03 to 87.11 | Percentage of time | |
| Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Drug: Isoflurane | 70.91 | 95% Confidence Interval 50.75 to 91.07 | Percentage of time | |
| Compare the Use of Opioids | Drug: Midazolam | 4.6 | 95% Confidence Interval 3.5 to 5.6 | μg/kg/h | |
| Compare the Use of Opioids | Drug: Isoflurane | 2.1 | 95% Confidence Interval 1.3 to 2.9 | μg/kg/h | |
| Compare the Use of Opioids | Drug: Midazolam | 0.58 | 95% Confidence Interval -0.16 to 1.32 | μg/kg/h | |
| Compare the Use of Opioids | Drug: Isoflurane | -0.19 | 95% Confidence Interval -0.74 to 0.35 | μg/kg/h | |
| Compare Time From End of Study Drug Administration to Extubation | Drug: Midazolam | 1.09 | Inter-Quartile Range 0.49 to 5.50 | hour | |
| Compare Time From End of Study Drug Administration to Extubation | Drug: Isoflurane | 0.75 | Inter-Quartile Range 0.25 to 1.5 | hour |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Drug: Midazolam | 33 | |
| Overall Study | STARTED | Drug: Isoflurane | 61 | |
| Overall Study | COMPLETED | Drug: Midazolam | 31 | |
| Overall Study | COMPLETED | Drug: Isoflurane | 60 | |
| Overall Study | NOT COMPLETED | Drug: Midazolam | 2 | |
| Overall Study | NOT COMPLETED | Drug: Isoflurane | 1 |
Source ClinicalTrials.gov
Adverse events92
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperthermia | General disorders | Drug: Midazolam | 2 | 33 | 2 |
| other | Hyperthermia | General disorders | Drug: Isoflurane | 1 | 61 | 1 |
| other | Pyrexia | General disorders | Drug: Midazolam | 2 | 33 | 2 |
| other | Pyrexia | General disorders | Drug: Isoflurane | 8 | 61 | 13 |
| other | Hypoxia | General disorders | Drug: Midazolam | 1 | 33 | 3 |
| other | Hypoxia | General disorders | Drug: Isoflurane | 4 | 61 | 12 |
| other | Pleural effusion | General disorders | Drug: Midazolam | 1 | 33 | 2 |
| other | Pleural effusion | General disorders | Drug: Isoflurane | 5 | 61 | 6 |
| other | Delirium | Psychiatric disorders | Drug: Midazolam | 1 | 33 | 1 |
| other | Delirium | Psychiatric disorders | Drug: Isoflurane | 5 | 61 | 5 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Drug: Midazolam | 2 | 33 |
| Total, all-cause mortality | Drug: Isoflurane | 1 | 61 |
| Total, other adverse events | Drug: Midazolam | 13 | 33 |
| Total, other adverse events | Drug: Isoflurane | 32 | 61 |
| Total, serious adverse events | Drug: Midazolam | 8 | 33 |
| Total, serious adverse events | Drug: Isoflurane | 19 | 61 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Drug: Midazolam vs Drug: Isoflurane: Compare the 30 Days/Hospital Mortality | Trial comparisons |
| Drug: Midazolam vs Drug: Isoflurane: Evaluate the Frequency of Delirium | Trial comparisons |
| Drug: Midazolam vs Drug: Isoflurane: Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction | Trial comparisons |
| Drug: Midazolam vs Drug: Isoflurane: deaths from any cause | Trial comparisons |
| Drug: Midazolam vs Drug: Isoflurane: Evaluate the Number of Patients With Withdrawal Symptom | Trial comparisons |
| Drug: Midazolam vs Drug: Isoflurane: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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