Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acacia Pharma Ltd
• Collaborator: Paion UK Ltd.

Criteria

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