Pain, PostoperativeNCT01547663
A Comparison of Pain Scales in Patients With Disorder of Consciousness Following Craniotomy
An observational study of Pain, Postoperative, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with disorder of consciousness within 48 hours following craniotomy
Who may be able to join
- Age > 18 years old
- Preoperative intracranial lesion which predicts delayed recovery
- Disorder of consciousness within 48 hours after craniotomy assessed by using Coma Recovery Scale-Revised (CRS-R) 17
- Not received postoperative sedation or muscle relaxants
Who cannot join
- Documented history of prior brain injury
- History of delayed development
- Prior psychiatric illness
- Prior neurological illness
- Superior limb contusion, fracture, paralysis -cannot move
- Thalamic hemorrhage -cannot express feeling
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
Suwannee Suraseranivongse, MD, 66814087655, sisur@mahidol.ac.th
Suwannee Suraseranivongse, MD
About this study
This study aims to test validity, reliability and practicality of translated NCS, CNPI and FLACC in unconscious patients in 48 hour following craniotomy.
Read the 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.
- Conditions
- Pain, Postoperative
- Keywords
- pain scale, craniotomy
- Medical subject headings
- Pain, Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwannee Suraseranivongse, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547663
- Sponsor's protocol ID
- SIRB 461/2554
- Status last verified
- Mar 2012
- First submitted
- 4 Mar 2012
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Pain Scales in Patients With Disorder of Consciousness Following Craniotomy
- ClinicalTrials.gov ID
- NCT01547663
- Acronym / sponsor ID
- SIRB 461/2554
- Conditions
- Pain, Postoperative
- Keywords
- pain scale, craniotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with disorder of consciousness within 48 hours following craniotomy
Key inclusion criteria (4 listed)
- Age > 18 years old
- Preoperative intracranial lesion which predicts delayed recovery
- Disorder of consciousness within 48 hours after craniotomy assessed by using Coma Recovery Scale-Revised (CRS-R) 17
- Not received postoperative sedation or muscle relaxants
Key exclusion criteria (6 listed)
- Documented history of prior brain injury
- History of delayed development
- Prior psychiatric illness
- Prior neurological illness
- Superior limb contusion, fracture, paralysis -cannot move
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2012; AzTrials last refreshed its copy on 8 Nov 2026.