Clinical trial · Interventional
Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
A Phase 2/3, Prospective, Open-label Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of Remimazolam for Intravenous Sedation in Paediatric Patients Undergoing Diagnostic and/or Therapeutic Procedures
NCT04851717CI-TRIAL-00091630active not recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remimazolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All Patients
- description
- All paediatric patients undergoing diagnostic and/or therapeutic procedures
- interventionNames
- Drug: Remimazolam
Primary outcomes (1)
- measure
- Success of the procedure
- timeFrame
- 2 hours
- description
- Success of the procedure defined as: Completion of the procedure AND no requirement for rescue sedative medication AND no requirement for more than the permitted bolus or infusion regimen
Secondary outcomes (14)
- measure
- Target depth of sedation achieved
- timeFrame
- 2 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.