Investigation of Remimazolam in children undergoing sedation for medical procedures

Phase 1

• Conditions: Paediatric procedural sedation; MedDRA version: 23.0Level: LLTClassification code 10083924Term: Sedation procedureSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-004118-37-DK
• Lead Sponsor: PAION UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-04
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Signed informed consent form and/or assent (if applicable) and willingness of patient and parent(s) to participate in 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.
? Patient aged <2 years must not be dosed in European sites until adequate supporting data are available from juvenile toxicity studies.
• 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. Only needs to be performed once if screening is on the same day as the treatment day.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 IMP
• Known paradoxical reactions to benzodiazepines
• History of sleep apnoea
• Active respiratory failure
• Active neuromuscular disease
• Active cardiac failure
• Active hepatic failure
• Pregnant or Breast-feeding females
• Prohibited medication:
? Any investigational drug when taken within 30 days or less than 7 half-lives (whichever is longer) before Treatment Day.
? Any medication given for sedative purposes other than nitrous oxide and IMP on the Treatment Day
? (For full list of prohibited medication after randomisation please see Protocol)
• Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the trial for any other reason

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified