Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients

July 12, 2019 updated by: Karuna Wongtangman, Mahidol University

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10170
        • Karuna Wongtangman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult surgical ICU patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day0- 2 after admitted to ICU
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
day 0-2 after admitted to ICU

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation
Time Frame: 30 days after admitted to ICU
30 days after admitted to ICU
ICU length of stay
Time Frame: 30 days after admitted to ICU
30 days after admitted to ICU
Mortality rate
Time Frame: 30 days after admitted to ICU
30 days after admitted to ICU
Incidence of acquired complication
Time Frame: 30 days after admitted to ICU
  • Ventilator associated pneumonia
  • GI hemorrhage
  • Venous thromboembolism
  • Central venous catheter colonization
30 days after admitted to ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

February 15, 2019

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 22, 2018

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI572/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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