We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Suwannee Suraseranivongse, Mahidol University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01547663
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Suwannee Suraseranivongse, Mahidol University
  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 Suwannee Suraseranivongse, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Suwannee Suraseranivongse, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01547663     History of Changes
Other Study ID Numbers: SIRB 461/2554
First Submitted: March 4, 2012
First Posted: March 8, 2012
Last Update Posted: March 8, 2012
Last Verified: March 2012

Keywords provided by Suwannee Suraseranivongse, Mahidol University:
pain scale
craniotomy

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