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A Comparison of Pain Scales in Patients With Disorder of Consciousness Following Craniotomy

M

Mahidol University

Status

Unknown

Conditions

Pain, Postoperative

Study type

Observational

Funder types

Other

Identifiers

NCT01547663
SIRB 461/2554

Details and patient eligibility

About

This study aims to test validity, reliability and practicality of translated NCS, CNPI and FLACC in unconscious patients in 48 hour following craniotomy.

Full description

This study aims to test predictive validity (sensitivity and specificity), content validity, concurrent validity, construct validity, inter-rater reliability and practicality of translated Nociception Coma Scale (NCS) , Checklist of Non Verbal Pain Indicator (CNPI) and the Faces, Legs, Activity, Cry, Consolability Observation Tool (FLACC) in unconscious patients in 48 hour following craniotomy.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age > 18 years old
  2. Preoperative intracranial lesion which predicts delayed recovery
  3. Disorder of consciousness within 48 hours after craniotomy assessed by using Coma Recovery Scale-Revised (CRS-R) 17
  4. Not received postoperative sedation or muscle relaxants

Exclusion criteria

  1. Documented history of prior brain injury
  2. History of delayed development
  3. Prior psychiatric illness
  4. Prior neurological illness
  5. Superior limb contusion, fracture, paralysis -cannot move
  6. Thalamic hemorrhage -cannot express feeling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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