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Measuring level of pain and comparing it with various clinical and other physiological assessments of perception of pain in patients with sudden onset injury to brain.

Quantification of the burden of pain and comparison of clinical and neurophysiological assessments of nociception and pain in patients with acute brain injury. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/03/081902
Enrollment
105
Registered
2025-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: S069- Unspecified intracranial injury

Interventions

Intervention1: Nil: Nil (observational study) Control Intervention1: Nil: Nil (observational study)

Sponsors

National Institute of Mental Health and Neurosciences (NIMHANS)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted to Neurocritical care unit with acute altered consciousness (Glasgow Coma Scale of less than 13), aged more than or equal to 18 years(no upper limit),presenting to ICU with neurological manifestations of acute brain injury (within 72 hours) due to traumatic and non-traumatic causes will be included.

Exclusion criteria

Exclusion criteria: Patients who do not give consent to participate in the study are excluded from the study. Those cases where due to technical and other reasons, we are not able to implement assessments are also excluded.

Design outcomes

Primary

MeasureTime frame
The burden of nociception or pain at rest using ANI with pain or nociception defined as ANI value of less than 50Timepoint: every hourly from 6 hours of admission for 24hours—

Secondary

MeasureTime frame
Comparison of the burden of pain assessed using BPS, ANI and cardiorespiratory parameters at rest and during painful stimuli.Timepoint: At rest and during one standard painful stimuli;Predictors of pain in patients with Acute brain injuryTimepoint: N/A;The impact of acute pain on clinical outcomes which includes length of ICU stay, length of hospital stay, duration of mechanical ventilation, GCS score and Glasgow outcome scale expanded (GOS E) score at hospital discharge, in hospital mortality and GOS E and severity of chronic pain assessed using NRS at 3 months following discharge.Timepoint: N/A;Impact of pain on daily activities and on quality of life using EuroQol 5-dimensional 5-level (EQ 5D-5L) questionnaire through telephonic interview at 3 months from dischargeTimepoint: 3 months from discharge from hospital;Impact of pain on quality of sleep using Richard Campbell questionnaire through telephonic interview at 3months from discharge Timepoint: 3 months from discharge from hospital—

Countries

India

Contacts

Public ContactDr Preena Babu

National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore

itz.sonia77@gmail.com9480829729

Outcome results

None listed

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