At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 94 enrolled
Drug / intervention
Midazolam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised Active-controlled Study to Compare Efficacy & Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) vs IV Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3-17 Years Old
In Brief
A Phase 3 clinical trial evaluating Midazolam and Isoflurane for Sedation. Completed, enrolled 94 participants across 24 sites in 5 countries.
Detailed Summary
This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device (ACD)) versus intravenous midazolam for sedation in mechanically ventilated children admitted to an intensive care unit.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedation
CountriesFrance, Germany, Spain, Sweden, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartJan 2021
Primary CompletionJan 2023
TodayJul 2026
First PostedDec 24, 2020
Enrollment StartJan 14, 2021
Primary CompletionJan 19, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.5 years ago
Interventions
Midazolamdrug
Solution for Injection/Infusion
Isofluranedrug
Inhalation vapour, liquid. Isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device)