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

NCT02435589 | Unknown

• 1 other identifier: EX 043 - EP2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• a) Level of pain (intensity, incidence of high levels of pain with a numerical pain scale NRS> 6, Behavioral pain scale (BPS) > 5 and Critical pain observation Tool (C-POT) >2

  morning between 9:00-11: hrs, and afternoon between 4:00-6:00 hrs) for ten continuous days

• To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to:The total dose, frequency of administration and the type of analgesics and sedatives received

  every 24 hrs for ten continuous days

Secondary Outcomes (9)

• Effect of the systematic evaluation of pain among patients groups - control and intervention as to:The degree of sedation/agitation

  morning between 9:00-11: hrs, and afternoon between 4:00-6:00 hrs) for ten continuous days

• Effect of the systematic evaluation of pain among patients groups - control and intervention as to:The levels of biochemical marker, cortisol, in the serum

  morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)

• Effect of the systematic evaluation of pain among patients groups - control and intervention as to:The levels of biochemical marker corticotrophin hormone -ACTH in the serum

  morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)

• Effect of the systematic evaluation of pain among patients groups - control and intervention as to: The levels of biochemical marker, b-endorphin in the serum

  morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)

• Effect of the systematic evaluation of pain among patients groups - control and intervention as to: The levels of neuropeptide Y

  morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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

Control Group

ACTIVE COMPARATOR

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

Other: Systematic pain assessment

Interventions

Systematic pain assessment 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.

Control Group; Intervention group

Notification of results of assessments 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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cyprus University of Technology: lead
• Nicosia General Hospital: collaborator

Study Sites (1)

Nicosia General Hospital

Nicosia, Cyprus

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evanthia G Georgiou, PhD Cand

  Cyprus University of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evanthia G Georgiou, PhD Cand

CONTACT

0035722603049; evagrn@spidernet.com.cy

Elizabeth DE Papathanassoglou, PhD

CONTACT

0035799824336; e.papathanassoglou@cut..ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: May 6, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 6, 2015

Record last verified: 2015-05

Locations

CY (1)