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Assessment and Management of Pain, Agitation, Delirium and Sleep Deprivation (PADS) in ICU by PADS Protocol, Thailand

Pain, Agitation, Delirium and Sleep Deprivation Assessment and Management in Intensive Care Units, Thailand: a Before-after Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04270331
Enrollment
509
Registered
2020-02-17
Start date
2020-04-01
Completion date
2021-06-30
Last updated
2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation on Recovery From Sedation, Delirium, Pain

Keywords

pain, agitation, sedation, delirium, protocol

Brief 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.

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

Interventions

OTHERPADS protocol

Assessment and management per PADS protocol

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A before-after study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults (18 years and older) * Patients admitted to medical or surgical intensive care units

Exclusion criteria

* Terminal ill patients, or patients unlikely to survive \> 24 hours

Design outcomes

Primary

MeasureTime frameDescription
ICU free daysDuring ICU stay or death or a maximum of 28 daysDays alive and not stay in ICU

Secondary

MeasureTime frameDescription
Delirium free daysDuring ICU stay or death or a maximum of 28 daysDay alive and free of delirium
Frequency of pain, agitation/sedation, delirium, sleep deprivation assessementDuring ICU stay or death or a maximum of 28 daysTimes per patient-days of evaluations during ICU stay
Incidence of in-target pain, agitation/sedation, deliriumDuring ICU stay or death or a maximum of 28 daysTimes per patient-days of in-target pain, agitation/sedation, delirium during ICU stay
Compliance to PADS protocolDuring ICU stay or death or a maximum of 28 daysTimes per patient-days of PADS protocol use by healthcare providers during ICU stay
Mechanical ventilator free daysDuring ICU stay or death or a maximum of 28 daysDay alive and free of mechanical ventilator
Antipsychotics useDuring ICU stay or death or a maximum of 28 daysType and dose of antipsychotics during ICU stay
Non-benzodiazepines useDuring ICU stay or death or a maximum of 28 daysType and dose of non-benzodiazepines during ICU stay
Benzodiazepines useDuring ICU stay or death or a maximum of 28 daysType and dose of non-benzodiazepines during ICU stay
All-cause hospital mortalityDuring hospital stay or death or a maximum of 90 daysRates of all-cause mortality during hospital stay

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026