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Comparison of effect of sedoanalgesia using ketamine and midazolam vs midazolam and fentanyl in management of raised intracranial pressure in children due to brain infections

Comparison of intravenous continuous infusion of ketamine-midazolam with fentanyl-midazolam combination as sedoanalgesia on cerebral haemodynamics in children with raised ICP due to acute CNS infections: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014622
Enrollment
70
Registered
2018-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Children aged between 1 to 12 years with raised intracranial pressure due to acute CNS infections Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Ketamine and midazolam: To compare cerebral hemodynamic parameters like CPP,ICP,MAP during sedoanalgesia with ketamine and midazolam in children with raised ICP Control Intervention1: F

Sponsors

Pediatric ICU PGIMER Chandigarh
Lead Sponsor
Dr Arun Bansal
Collaborator
Dr Jayashree Muralidharan
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All children 1-12year old admitted with raised ICP due to acute CNS infections and undergoing invasive intraparenchymal ICP monitoring.

Exclusion criteria

Exclusion criteria: Acute liver failure Oliguric AKI Known hypersensitivity and contraindication to study drugs. Known chronic neurological illness Traumatic brain injury, extradural, subdural and subarachnoid haemorrhage, CNS tumours, hydrocephalus Clinical brain death at admission Infection at the site of ICP catheter insertion Hypertensive encephalopathy Children with more than 7 days of illness

Design outcomes

Primary

MeasureTime frame
To compare cerebral hemodynamics (CPP, ICP, MAP) during continuous intravenous infusion of sedoanalgesia with ketamine+midazolam and midazolam+fentanyl combination in 1- 12year old children with raised ICP due to acute CNS infectionsTimepoint: January 2018- June 2019,—

Secondary

MeasureTime frame
Mortality at PICU discharge Time for resolution of raised ICP GCS at 72 hours, 120 hours and PICU discharge Ventilation free days Timepoint: January 2018- June 2019,—

Countries

India

Contacts

Public ContactDr Arun Bansal

PGIMER Chandigarh

drarunbansal@gmail.com9815455002

Outcome results

None listed

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