Incidence of Inadequate Pain Treatment in Ventilated Crit... | NCT03641911

Studies
Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients

NCT03641911

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jul 16, 2019Actual

Enrollment

118Actual

Phase

Not provided

Conditions

Adult ICU Patients
Pain, Acute

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2017Actual

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Feb 15, 2019Actual

First Submitted Date

Nov 8, 2017

First Submission Date that Met QC Criteria

Aug 21, 2018

First Posted Date

Aug 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2019

Last Update Posted Date

Jul 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

To date, Thai-version of BPS and CPOT were validated, the incidence of inappropriate pain management in SICU, Siriraj hospital should be assessed.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overtreatment of pain (Richmond agitation sedation scale)	Richmond agitation sedation scale -3 to -5 undertreatment NRS 4-10 or CPOT 3-8	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	day 0-2 after admitted to ICU

Secondary Outcomes

Measure	Description	Time Frame
Mortality rate		30 days after admitted to ICU
ICU length of stay		30 days after admitted to ICU
Duration of mechanical ventilation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 years.
Expected duration of mechanical ventilation of more than 24 hours.

Exclusion Criteria:

Quadriplegia.
Receiving neuromuscular blocking medications.
Coma or severe brain injury
Neurosurgery/ CVT patients/ trauma patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult surgical ICU patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karuna Wongtangman		Bangkok Noi	Bangkok	10170	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided