Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Pediatric ALL

In brief

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

Key facts

Study ID

NCT04851717

Run by

Acacia Pharma Ltd

People needed

100

Starts

2021-11-15

Expected to finish

2027-10-01

Last updated by the study team

2025-07-01

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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

Where it is running

• Stanford University — Palo Alto, California, United States
• University of California Davis Children's Hospital — Sacramento, California, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States
• University of Pittsburgh Medical Center - Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• Rigshospitalet — Copenhagen, Denmark
• Odense Universitetshospital — Odense, Denmark

Full record on ClinicalTrials.gov

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