WHO ICTRP trial
A Study to Compare the Effect and Safety of Inhaled Isoflurane to Intravenous…
EUCTR2020-000578-31-FR · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2020-000578-31-FR |
|---|---|
| Public title | A Study to Compare the Effect and Safety of Inhaled Isoflurane to Intravenous Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old |
| Scientific title | A Randomised Active-controlled Study to Compare Efficacy and Safety of Inhaled Isoflurane Delivered by the AnaConDa-S (Anaesthetic Conserving Device) to Intravenous Midazolam for Sedation in Mechanically Ventilated Paediatric Patients 3 to 17 (Less than 18) Years Old - IsoCOMFORT study |
| Primary sponsor | Sedana Medical AB |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France;Spain;Germany;Sweden |
| Conditions | Sedation in Mechanically Ventilated Paediatric Patients 3 to 17 (Less than 18) Years Old MedDRA version: 20.0 Level: PT Classification code 10039897 Term: Sedation System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1… |
| Interventions | Trade Name: ISOFLURANE 100% Inhalation vapour, liquid Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: ISOFLURANE CAS Number: 26675-46-7 Concentration unit: % (V/V) percent volume/volume Concentration type: equal… |
| Registration date | Feb 7, 2020 |
| Target size | 160 |
| Secondary IDs | SED002;2020-000578-31-SE |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: