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

Primary Purpose

Pain

Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Systematic pain assessment
Notification of results of assessments
Sponsored by
Cyprus University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Nicosia General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Effect of the systematic evaluation of pain among patients groups - control and intervention as to:The degree of sedation/agitation
Effect of the systematic evaluation of pain among patients groups - control and intervention as to:The levels of biochemical marker, cortisol, in the serum
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
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
Effect of the systematic evaluation of pain among patients groups - control and intervention as to: The levels of neuropeptide Y
Effect of the systematic evaluation of pain among patients groups - control and intervention as to: The levels of neuropeptide , substance P in the serum
To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to duration of mechanical ventilation
To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to length of stay in the ICU
To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to the occurrence of adverse events

Full Information

First Posted
April 22, 2015
Last Updated
May 2, 2015
Sponsor
Cyprus University of Technology
Collaborators
Nicosia General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02435589
Brief Title
The Effects of a Systematic Pain Assessment Approach on Critically Ill Patients Outcomes in ICU
Official Title
The Effects of a Systematic Pain Assessment Approach on Critically Ill Patients Outcomes: A Randomized Interventional Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology
Collaborators
Nicosia General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Intervention. Systematic pain assessments. Assessments of pain will be done by independent assessors but results will not be notified to nurses or physicians
Intervention Type
Other
Intervention Name(s)
Systematic pain assessment
Intervention Description
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
Intervention Name(s)
Notification of results of assessments
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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.
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evanthia G Georgiou, PhD Cand
Phone
0035722603049
Email
evagrn@spidernet.com.cy
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth DE Papathanassoglou, PhD
Phone
0035799824336
Email
e.papathanassoglou@cut..ac.cy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evanthia G Georgiou, PhD Cand
Organizational Affiliation
Cyprus University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nicosia General Hospital
City
Nicosia
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodoros Kyprianou, PhD
Phone
22603813
Email
drtheo@cytanet.com.cy
First Name & Middle Initial & Last Name & Degree
Evanthia G Georgiou, PhD cand

12. IPD Sharing Statement

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

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