NCT03641911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

November 8, 2017

Last Update Submit

July 12, 2019

Conditions

Adult ICU PatientsPain, Acute

Keywords

incidencesurgical ICU

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • Mortality rate

    30 days after admitted to ICU

  • ICU length of stay

    30 days after admitted to ICU

  • Duration of mechanical ventilation

    30 days after admitted to ICU

  • Incidence of acquired complication

    30 days after admitted to ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult surgical ICU patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karuna Wongtangman

Bangkok Noi, Bangkok, 10170, Thailand

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

November 8, 2017

First Posted

August 22, 2018

Study Start

November 15, 2017

Primary Completion

January 31, 2019

Study Completion

February 15, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations

TH(1)