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

• Conditions: Pain, Postoperative

• Registration Number: NCT01547663
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted: 2012-03-04
• Study First Submitted QC: 2012-03-07
• Last Update Submitted: 2012-03-07
• Study First Posted: 2012-03-08
• Last Update Posted: 2012-03-08
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand