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NCT01547663 Clinical Trial

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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01547663
Other study ID # SIRB 461/2554
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 4, 2012
Last updated March 7, 2012
Start date March 2012
Est. completion date December 2013

Study information
Verified date March 2012
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date December 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Thailand Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

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