The Effects of a Systematic Pain Assessment Approach on Critically Ill Patients Outcomes in ICU

NCT ID: NCT02435589

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-05-31

Brief Summary

The purpose of this study is to investigate the effectiveness of a systematic approach to pain assessment in the critically ill patients' outcome The investigators hypothesize that, patients who will undergo systematic pain assessment and they will have their results notified to physicians and nurses, will demonstrate favorable effects on pain intensity, more efficient use of sedatives and analgesics, duration of mechanical ventilation, length of ICU stay, mortality, adverse events and complications, in relation to patients who will receive standard care alone. Moreover it is expected that they will demonstrate altered levels of plasma neuropeptides and biochemical markers in peripheral blood.

Detailed Description

Appropriate pain management depends on the systematic and comprehensive assessment of pain. Inaccurate pain assessment and the resulting inadequate treatment of pain in critically ill adults can have significant physiological and psychological consequences.

The investigators will examine whether a systematic pain assessment approach can improve patients outcomes.

120 ICU patients will be randomized either to control or intervention group. The control group will receive standard care plus pain assessments but nurses and physicians will be blind of these results. The intervention group will receive standard care plus systematic pain assessment and the results will be notified to nurses and physicians.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

Intervention:

1. systematic pain assessment

2. Notification of results of assessments to nurses and physicians. Pain Assessments will be done with the use of 2 different behavioral pain tools by independent assessors and the results of the assessments will be notified to the nurses and physicians and their respond will be observed and documented

Group Type: EXPERIMENTAL

Systematic pain assessment

Intervention Type: OTHER

Systematic assessment of pain twice daily with the use of 2 different behavioral pain tools (Behavioral Pain Scale - BPS, and Critical Care Pain Observation Tool - C-POT) for non-communicative patients and Numerical Rating Scale (NRS) 1-10 for communicative patients.

Notification of results of assessments

Intervention Type: OTHER

Pain assessments will be carried out by independent investigators who will notify the results to ICU nurses and physicians and observe and document their reaction

Control Group

Intervention. Systematic pain assessments. Assessments of pain will be done by independent assessors but results will not be notified to nurses or physicians

Group Type: ACTIVE_COMPARATOR

Systematic pain assessment

Intervention Type: OTHER

Systematic assessment of pain twice daily with the use of 2 different behavioral pain tools (Behavioral Pain Scale - BPS, and Critical Care Pain Observation Tool - C-POT) for non-communicative patients and Numerical Rating Scale (NRS) 1-10 for communicative patients.

Interventions

Systematic pain assessment

Systematic assessment of pain twice daily with the use of 2 different behavioral pain tools (Behavioral Pain Scale - BPS, and Critical Care Pain Observation Tool - C-POT) for non-communicative patients and Numerical Rating Scale (NRS) 1-10 for communicative patients.

Intervention Type: OTHER

Notification of results of assessments

Pain assessments will be carried out by independent investigators who will notify the results to ICU nurses and physicians and observe and document their reaction

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years and older
• All patients with an estimated source of pain or due to immunological process as trauma, surgery, or due to general factors such as endotracheal intubation, interventional catheters

Exclusion Criteria

• Length of stay in the ICU <24 hours
• The patient receives neuromuscular blockers,
• The patient has a disease or condition, such as Guillain-Barre, peripheral neuropathy, which modifies sensory transmission of painful stimuli
• The patient has a disease or condition which complicates the assessment of pain behavior, such as decerebration or vegetative state, agitation> 3 in the Richmond Agitation sedation Scale (RASS)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nicosia General Hospital

OTHER

Sponsor Role: collaborator

Cyprus University of Technology

OTHER

Sponsor Role: lead

Responsible Party

Evanthia Georgiou

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evanthia G Georgiou, PhD Cand

Role: PRINCIPAL_INVESTIGATOR

Cyprus University of Technology

Locations

Nicosia General Hospital

Nicosia, , Cyprus

Site Status: RECRUITING

Countries

Cyprus

Central Contacts

Evanthia G Georgiou, PhD Cand

Role: CONTACT

evagrn@spidernet.com.cy

0035722603049

Elizabeth DE Papathanassoglou, PhD

Role: CONTACT

e.papathanassoglou@cut..ac.cy

0035799824336

Facility Contacts

Theodoros Kyprianou, PhD

Role: primary

drtheo@cytanet.com.cy

22603813

Other Identifiers

EX 043 - EP2

Identifier Type: -

Identifier Source: org_study_id