Inclusion Criteria:  Signed informed consent form and/or assent and willingness of patient and parent(s) to participate in the trial. In US sites: Paediatric male or female patients, aged ≥3 and <18 years scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial. In European sites: Paediatric male or female patients, aged full term birth to <18 years scheduled to undergo a diagnostic or therapeutic procedure, which is medically indicated and independent from the trial. Maximum planned duration of procedure: 2 hours ASA Physical Status I-III Planned spontaneous breathing during sedation A female who is of child bearing potential (i.e. after menarche) and sexually active must use a highly effective method of birth control during the trial period (from the time of consent until all specified observations are completed) Negative pregnancy test at screening and on treatment day -  Exclusion Criteria:  Emergency procedures Condition/procedure that requires planned airway control via endotracheal tube or LMA/IGEL insertion Cranio-facial malformation, which would severely limit the possibilities for emergency airway rescue Other abnormalities relating to the airway (including large tonsils and anatomical abnormalities of upper airway or lower airway) which may compromise emergency airway rescue Known hypersensitivity to benzodiazepines, flumazenil, dextran or any of the ingredients of the drug product Known paradoxical reactions to benzodiazepines History of sleep apnoea Active respiratory failure Active neuromuscular disease Active cardiac failure Active hepatic failure Breast feeding females Prohibited medication Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the trial for any other reason