Adult ICU PatientsNCT03641911
Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients
An observational study of Adult ICU Patients and Pain, Acute, run by Mahidol University at 1 site in Thailand.
Trial summary
In SICU, Siriraj hospital there were no protocols place for the management of pain. All decisions were made according the attending physicians. There were no information about incidence of inappropriate pain management in SICU due to lack of validated tool for assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult ICU Patients, Pain, Acute
- How many people
- 118 participants
- Where
- 1 siteThailand
- Study dates
- 15 Nov 2017to 15 Feb 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult surgical ICU patients
Who may be able to join
- Older than 18 years.
- Expected duration of mechanical ventilation of more than 24 hours.
Who cannot join
- Quadriplegia.
- Receiving neuromuscular blocking medications.
- Coma or severe brain injury
- Neurosurgery/ CVT patients/ trauma patients
Trial locations and contacts
1 site in 1 country.
About this study
In SICU, Siriraj hospital there were no protocols place for the management of pain. All decisions were made according the attending physicians.
There were no information about incidence of inappropriate pain management in SICU due to lack of validated tool for assessment.
To date, Thai-version of BPS and CPOT were validated, the incidence of inappropriate pain management in SICU, Siriraj hospital should be assessed.
- Conditions
- Adult ICU Patients, Pain, Acute
- Keywords
- incidence, surgical ICU
- Medical subject headings
- Acute Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
overtreatment of pain (Richmond agitation sedation scale)
Richmond agitation sedation scale -3 to -5 undertreatment NRS 4-10 or CPOT 3-8
Measured: day0- 2 after admitted to ICU
inadequate treatment of pain (Numeral rating scale)
Numeral rating scale 4-10 in communicable patient or critical care pain observation tool 3-8 in non-communicable patients
Measured: day 0-2 after admitted to ICU
Secondary outcomes (4)
Mortality rate
Measured: 30 days after admitted to ICU
ICU length of stay
Measured: 30 days after admitted to ICU
Duration of mechanical ventilation
Measured: 30 days after admitted to ICU
Incidence of acquired complication
- Ventilator associated pneumonia
- GI hemorrhage
- Venous thromboembolism
- Central venous catheter colonization
Measured: 30 days after admitted to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start15 Nov 2017
- Primary completion31 Jan 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ICU PatientsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karuna Wongtangman, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641911
- Sponsor's protocol ID
- SI572/2017
- Status last verified
- Jul 2019
- First submitted
- 8 Nov 2017
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients
- ClinicalTrials.gov ID
- NCT03641911
- Acronym / sponsor ID
- SI572/2017
- Conditions
- Adult ICU Patients, Pain, Acute
- Keywords
- incidence, surgical ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 22 Aug 2018 (actual)
- 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.
In SICU, Siriraj hospital there were no protocols place for the management of pain. All decisions were made according the attending physicians.
There were no information about incidence of inappropriate pain management in SICU due to lack of validated tool for assessment.
To date, Thai-version of BPS and CPOT were validated, the incidence of inappropriate pain management in SICU, Siriraj hospital should be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult surgical ICU patients
Key inclusion criteria (2 listed)
- Older than 18 years.
- Expected duration of mechanical ventilation of more than 24 hours.
Key exclusion criteria (4 listed)
- Quadriplegia.
- Receiving neuromuscular blocking medications.
- Coma or severe brain injury
- Neurosurgery/ CVT patients/ trauma patients
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
overtreatment of pain (Richmond agitation sedation scale)
Time frame: day0- 2 after admitted to ICU
Richmond agitation sedation scale -3 to -5 undertreatment NRS 4-10 or CPOT 3-8
inadequate treatment of pain (Numeral rating scale)
Time frame: day 0-2 after admitted to ICU
Numeral rating scale 4-10 in communicable patient or critical care pain observation tool 3-8 in non-communicable patients
4 secondary outcomes
Mortality rate
Time frame: 30 days after admitted to ICU
ICU length of stay
Time frame: 30 days after admitted to ICU
Duration of mechanical ventilation
Time frame: 30 days after admitted to ICU
Incidence of acquired complication
Time frame: 30 days after admitted to ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adult ICU Patients and Pain, Acute, 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overtreatment of pain (Richmond agitation sedation scale) (time frame: day0- 2 after admitted to ICU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 16 Jul 2019.