Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients

Pain, Acute Clinical Trial

Official title:

Incidence of Inadequate Pain Treatment in Ventilated Critically Ill Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641911
• Other study ID #: SI572/2017
• Status: Completed
• Start date: November 15, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: July 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 15, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Adult ICU Patients
• Critical Illness
• Pain, Acute

Locations

Country	Name	City	State
Thailand	Karuna Wongtangman	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mortality rate		30 days after admitted to ICU
Secondary	ICU length of stay		30 days after admitted to ICU
Secondary	Duration of mechanical ventilation		30 days after admitted to ICU
Secondary	Incidence of acquired complication	Ventilator associated pneumonia; GI hemorrhage; Venous thromboembolism; Central venous catheter colonization	30 days after admitted to ICU