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

Cyprus University of Technology

Status: Unknown

Conditions: Pain

Treatments: Other: Notification of results of assessments; Other: Systematic pain assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT02435589

EX 043 - EP2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Other: Systematic pain assessment

Other: Notification of results of assessments

Control Group

Active Comparator group

Description:

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

Treatment:

Other: Systematic pain assessment