PainNCT04270331
Assessment and Management of Pain, Agitation, Delirium and Sleep Deprivation (PADS) in ICU by PADS Protocol, Thailand
A study testing PADS protocol in people with Pain and Agitation on Recovery From Sedation, run by Mahidol University at 1 site in Thailand.
Trial summary
The investigators proposed that pain, agitation, delirium and sleep deprivation protocol (PADS) will help improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Agitation on Recovery From Sedation, Delirium
- What is being tested?
- PADS protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 509 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2020to 30 Jun 2021
- Phase
- Interventional
- 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
Who may be able to join
- Adults (18 years and older)
- Patients admitted to medical or surgical intensive care units
Who cannot join
- Terminal ill patients, or patients unlikely to survive > 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain, Agitation, Delirium and Sleep Deprivation Assessment and Management in Intensive Care Units, Thailand: a Before-after Study
The investigators proposed that pain, agitation, delirium and sleep deprivation protocol (PADS) will help improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.
Read the detailed description
Pain is frequently reported in patients admitted to an ICU, with an incidence of up to 50% in medical patients during admission, and increasing up to 80% during standard care procedures. Agitation was also reported in 52% of the patients, typically within 4-9 days after admission. However, there were studies reporting inadequate pain, agitation and delirium assessment and management in real-world clinical practice. The clinical practice guideline for the management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU was recently published in 2018 and emphasized routinely monitoring pain, agitation and delirium during ICU admissions. Also, appropriate management of pain and agitation in critically ill patients resulted in reduction in ICU length of stay, hospital length of stay, delirium and mortality. Therefore, structural pain, agitation/sedation, delirium assessment and treatment in the ICUs, Thailand might be necessary.
Since pain, agitation/sedation and delirium protocol has not yet been initiated in ICUs, Thailand, this study is designed as a before-after study in order to assess outcomes by comparing between before and after protocol initiation. The objectives of the study were to document the impact of pain, agitation/sedation, delirium protocol on clinical outcomes of ICU patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand
- Conditions
- Pain, Agitation on Recovery From Sedation, Delirium
- Being tested
- PADS protocol
- Keywords
- pain, agitation, sedation, delirium, protocol
- Medical subject headings
- Pain, Delirium, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PADS protocolOther
Assessment and management per PADS protocol
| Study group | Role | What they receive |
|---|---|---|
| A Before group | No intervention | No protocol assigned |
| An After group | Experimental | PADS (pain, agitation, delirium, sleep deprivation assessment and management) protocol assigned Receives: Other: PADS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU free days
Days alive and not stay in ICU
Measured: During ICU stay or death or a maximum of 28 days
Secondary outcomes (9)
Mechanical ventilator free days
Day alive and free of mechanical ventilator
Measured: During ICU stay or death or a maximum of 28 days
Delirium free days
Day alive and free of delirium
Measured: During ICU stay or death or a maximum of 28 days
Frequency of pain, agitation/sedation, delirium, sleep deprivation assessement
Times per patient-days of evaluations during ICU stay
Measured: During ICU stay or death or a maximum of 28 days
Incidence of in-target pain, agitation/sedation, delirium
Times per patient-days of in-target pain, agitation/sedation, delirium during ICU stay
Measured: During ICU stay or death or a maximum of 28 days
Compliance to PADS protocol
Times per patient-days of PADS protocol use by healthcare providers during ICU stay
Measured: During ICU stay or death or a maximum of 28 days
All-cause hospital mortality
Rates of all-cause mortality during hospital stay
Measured: During hospital stay or death or a maximum of 90 days
Antipsychotics use
Type and dose of antipsychotics during ICU stay
Measured: During ICU stay or death or a maximum of 28 days
Non-benzodiazepines use
Type and dose of non-benzodiazepines during ICU stay
Measured: During ICU stay or death or a maximum of 28 days
Benzodiazepines use
Type and dose of non-benzodiazepines during ICU stay
Measured: During ICU stay or death or a maximum of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Apr 2020
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A before-after study
- Masking
- None (open label)
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pitchaya Dilokpattanamongkol, Mahidol University
- Investigators
- Punchika Luetrakool, MD, Principal investigator, Ramathibodi hospital, Mahidol university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270331
- Sponsor's protocol ID
- MURA2020/151
- Status last verified
- Aug 2021
- First submitted
- 12 Feb 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share individual participant data per request and after 2 years from publications
Publications
Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PubMed 30113379Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
PubMed 23269131Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014 Jan 30;370(5):444-54. doi: 10.1056/NEJMra1208705. No abstract available.
PubMed 24476433
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain, Agitation, Delirium and Sleep Deprivation Assessment and Management in Intensive Care Units, Thailand: a Before-after Study
- ClinicalTrials.gov ID
- NCT04270331
- Acronym / sponsor ID
- MURA2020/151
- Conditions
- Pain, Agitation on Recovery From Sedation, Delirium
- Keywords
- pain, agitation, sedation, delirium, protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Feb 2020 (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.
The investigators proposed that pain, agitation, delirium and sleep deprivation protocol (PADS) will help improve the patients' outcomes (shortening ICU length of stay, improving ventilator free days, increasing delirium free days) in critically ill patients, a university hospital, Thailand.
Detailed description
Pain is frequently reported in patients admitted to an ICU, with an incidence of up to 50% in medical patients during admission, and increasing up to 80% during standard care procedures. Agitation was also reported in 52% of the patients, typically within 4-9 days after admission. However, there were studies reporting inadequate pain, agitation and delirium assessment and management in real-world clinical practice. The clinical practice guideline for the management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU was recently published in 2018 and emphasized routinely monitoring pain, agitation and delirium during ICU admissions. Also, appropriate management of pain and agitation in critically ill patients resulted in reduction in ICU length of stay, hospital length of stay, delirium and mortality. Therefore, structural pain, agitation/sedation, delirium assessment and treatment in the ICUs, Thailand might be necessary.
Since pain, agitation/sedation and delirium protocol has not yet been initiated in ICUs, Thailand, this study is designed as a before-after study in order to assess outcomes by comparing between before and after protocol initiation. The objectives of the study were to document the impact of pain, agitation/sedation, delirium protocol on clinical outcomes of ICU patients admitted to ICUs at Ramathibodi Hospital, a university hospital, Thailand
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A before-after study
| Arm | Type | Receives |
|---|---|---|
| A Before group | No intervention | –No protocol assigned |
| An After group | Experimental | Other: PADS protocolPADS (pain, agitation, delirium, sleep deprivation assessment and management) protocol assigned |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (18 years and older)
- Patients admitted to medical or surgical intensive care units
Key exclusion criteria (1 listed)
- Terminal ill patients, or patients unlikely to survive > 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PADS protocolAssessment and management per PADS protocol | Other | An After group |
Primary outcome
ICU free days
Time frame: During ICU stay or death or a maximum of 28 days
Days alive and not stay in ICU
9 secondary outcomes
Mechanical ventilator free days
Time frame: During ICU stay or death or a maximum of 28 days
Delirium free days
Time frame: During ICU stay or death or a maximum of 28 days
Frequency of pain, agitation/sedation, delirium, sleep deprivation assessement
Time frame: During ICU stay or death or a maximum of 28 days
Incidence of in-target pain, agitation/sedation, delirium
Time frame: During ICU stay or death or a maximum of 28 days
Compliance to PADS protocol
Time frame: During ICU stay or death or a maximum of 28 days
All-cause hospital mortality
Time frame: During hospital stay or death or a maximum of 90 days
Antipsychotics use
Time frame: During ICU stay or death or a maximum of 28 days
Non-benzodiazepines use
Time frame: During ICU stay or death or a maximum of 28 days
Benzodiazepines use
Time frame: During ICU stay or death or a maximum of 28 days
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 1 Sep 2021.
- Background: PubMed 30113379Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
- Background: PubMed 23269131Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.
- Background: PubMed 24476433Reade MC, Finfer S. Sedation and delirium in the intensive care unit. N Engl J Med. 2014 Jan 30;370(5):444-54. doi: 10.1056/NEJMra1208705. No abstract available.
- Individual participant dataSharing planned: Yes. Plan to share individual participant data per request and after 2 years from publications
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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.
Punchika Luetrakool, MD principal investigator
Ramathibodi hospital, Mahidol university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PADS protocol in people with Pain and Agitation on Recovery From Sedation, 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 1 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 1 Sep 2021. 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?
ICU free days (time frame: During ICU stay or death or a maximum of 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04270331, which also lists 3 linked publications.
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 1 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.