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

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ClinicalTrials.gov Identifier: NCT02435589
Recruitment Status : Unknown
Verified May 2015 by Evanthia Georgiou, Cyprus University of Technology.
Recruitment status was:  Recruiting
First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Collaborator:
Nicosia General Hospital
Information provided by (Responsible Party):
Evanthia Georgiou, Cyprus University of Technology

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.

Condition or disease Intervention/treatment Phase
Pain Other: Systematic pain assessment Other: Notification of results of assessments Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of a Systematic Pain Assessment Approach on Critically Ill Patients Outcomes: A Randomized Interventional Clinical Study
Study Start Date : March 2015
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: 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
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.




Primary Outcome Measures :
  1. 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 [ Time Frame: morning between 9:00-11: hrs, and afternoon between 4:00-6:00 hrs) for ten continuous days ]
  2. 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 [ Time Frame: every 24 hrs for ten continuous days ]

Secondary Outcome Measures :
  1. Effect of the systematic evaluation of pain among patients groups - control and intervention as to:The degree of sedation/agitation [ Time Frame: morning between 9:00-11: hrs, and afternoon between 4:00-6:00 hrs) for ten continuous days ]
  2. Effect of the systematic evaluation of pain among patients groups - control and intervention as to:The levels of biochemical marker, cortisol, in the serum [ Time Frame: morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample) ]
  3. 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 [ Time Frame: morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample) ]
  4. 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 [ Time Frame: morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample) ]
  5. Effect of the systematic evaluation of pain among patients groups - control and intervention as to: The levels of neuropeptide Y [ Time Frame: morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample) ]
  6. Effect of the systematic evaluation of pain among patients groups - control and intervention as to: The levels of neuropeptide , substance P in the serum [ Time Frame: morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample) ]
  7. To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to duration of mechanical ventilation [ Time Frame: Day and time of initiation of mechanical ventilation till the day and time of end of mechanical ventilation, up to six months. ]
  8. To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to length of stay in the ICU [ Time Frame: From the day of admission to ICU till the day of discharge from ICU, up to six months ]
  9. To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to the occurrence of adverse events [ Time Frame: every 24 hrs for ten continuous days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435589


Contacts
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Contact: Evanthia G Georgiou, PhD Cand 0035722603049 evagrn@spidernet.com.cy
Contact: Elizabeth DE Papathanassoglou, PhD 0035799824336 e.papathanassoglou@cut..ac.cy

Locations
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Cyprus
Nicosia General Hospital Recruiting
Nicosia, Cyprus
Contact: Theodoros Kyprianou, PhD    22603813    drtheo@cytanet.com.cy   
Principal Investigator: Evanthia G Georgiou, PhD cand         
Sponsors and Collaborators
Cyprus University of Technology
Nicosia General Hospital
Investigators
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Principal Investigator: Evanthia G Georgiou, PhD Cand Cyprus University of Technology
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Responsible Party: Evanthia Georgiou, PhD student, Cyprus University of Technology
ClinicalTrials.gov Identifier: NCT02435589    
Other Study ID Numbers: EX 043 - EP2
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes