Clinical Research Directory

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