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

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ClinicalTrials.gov Identifier: NCT01547663
Recruitment Status : Unknown
Verified March 2012 by Suwannee Suraseranivongse, Mahidol University.
Recruitment status was:  Not yet recruiting
First Posted : March 8, 2012
Last Update Posted : March 8, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Pain, Postoperative

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 Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comparison of Pain Scales in Patients With Disorder of Consciousness Following Craniotomy
Study Start Date : March 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: March 8, 2012    Key Record Dates
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