Text Size

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

This study is not yet open for participant recruitment.
Verified March 2012 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Suwannee Suraseranivongse, Mahidol University
ClinicalTrials.gov Identifier:
NCT01547663
First received: March 4, 2012
Last updated: March 7, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition
Pain, Postoperative

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comparison of Pain Scales in Patients With Disorder of Consciousness Following Craniotomy

Further study details as provided by Mahidol University:

Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with disorder of consciousness within 48 hours following craniotomy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547663

Locations
Thailand
Siriraj Hospital, Mahidol University Not yet recruiting
Bangkok, Thailand, 10700
Contact: Suwannee Suraseranivongse, MD     66814087655     sisur@mahidol.ac.th    
Principal Investigator: Suwannee Suraseranivongse, MD            
Sponsors and Collaborators
Mahidol University
  More Information

No publications provided

Responsible Party: Suwannee Suraseranivongse, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01547663     History of Changes
Other Study ID Numbers: SIRB 461/2554
Study First Received: March 4, 2012
Last Updated: March 7, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
pain scale
craniotomy

Additional relevant MeSH terms:
Consciousness Disorders
Pain, Postoperative
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Pain

ClinicalTrials.gov processed this record on May 23, 2013