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The effect of risperidone on delirium indices.

Investigating the effect of risperidone on delirium indices in patients admitted to the PICU

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250611066179N1
Enrollment
54
Registered
2025-08-04
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium indicators in patients admitted to PICU. Delirium due to known physiological condition

Interventions

Intervention 1: Intervention group: Individuals who entered the study and were initially diagnosed with delirium will receive the fifth dose of risperidone at a dose of 0.02 mg/kg. Intervention 2: Con

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
28 Days to 18 Years

Inclusion criteria

Inclusion criteria: Patients admitted to the PICU Cornel score greater than or equal to 9 Age: 28 days to 18 years Minimal oral tolerance

Exclusion criteria

Exclusion criteria: Diagnosis of long QTsyn History and diagnosis of neuroleptic malignant syndrome Use of risperidone or other antipsychotic medications prior to admission with another diagnosis

Design outcomes

Primary

MeasureTime frame
Delirium indicators. Timepoint: At the beginning of the study, during and until the end of the study, every 12 hours for 5 days. Method of measurement: Agitation Sedation Richmond scale by patient observation.;Duration of oxygen and mechanical ventilation use. Timepoint: At the beginning of the study, during and until the end of the study, every 12 hours for 5 days. Method of measurement: Observation.

Secondary

MeasureTime frame
Duration of hospitalization. Timepoint: Hospital discharge day. Method of measurement: Registration in the patient file.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyedeh Maryam Ghodsi Khorsand

Tehran University of Medical Sciences

smghodsikh@tums.ac.ir+98 21 7301 3000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026