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

The Effects of a Systematic Pain Assessment Approach on Critically Ill Patients Outcomes: A Randomized Interventional Clinical Study

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Other: Systematic pain assessment; Other: Notification of results of assessments

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth DE Papathanassoglou, PhD; Phone Number: 0035799824336; Email: e.papathanassoglou@cut..ac.cy
• Study Contact Backup: Name: Evanthia G Georgiou, PhD Cand; Phone Number: 0035722603049; Email: evagrn@spidernet.com.cy

Study Locations

• Cyprus
  • Nicosia, Cyprus
    • Recruiting
    • Nicosia General Hospital
    • Contact: Theodoros Kyprianou, PhD; Phone Number: 22603813; Email: drtheo@cytanet.com.cy
    • Principal Investigator: Evanthia G Georgiou, PhD cand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intervention: systematic pain assessment; 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; 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.; 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
Active Comparator: 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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)
Effect of the systematic evaluation of pain among patients groups - control and intervention as to: The levels of neuropeptide , substance P in the serum	morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to duration of mechanical ventilation	Day and time of initiation of mechanical ventilation till the day and time of end of mechanical ventilation, up to six months.
To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to length of stay in the ICU	From the day of admission to ICU till the day of discharge from ICU, up to six months
To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to the occurrence of adverse events	every 24 hrs for ten continuous days

Collaborators and Investigators

• Sponsor: Cyprus University of Technology
• Collaborators: Nicosia General Hospital
• Investigators: Principal Investigator: Evanthia G Georgiou, PhD Cand, Cyprus University of Technology

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: May 2, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Estimate): May 6, 2015
• Last Update Submitted That Met QC Criteria: May 2, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: EX 043 - EP2