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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02435589
• Other study ID #: EX 043 - EP2
• Status: Recruiting
• Phase: N/A
• First received: April 22, 2015
• Last updated: May 2, 2015
• Start date: March 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2015
• Source: Cyprus University of Technology
• Contact: Evanthia G Georgiou, PhD Cand
• Phone: 0035722603049
• Email: evagrn[@]spidernet.com.cy
• Is FDA regulated: No
• Health authority: Cyprus: Cyprus National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness
• Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
Cyprus	Nicosia General Hospital	Nicosia

Sponsors (2)

Lead Sponsor	Collaborator
Cyprus University of Technology	Nicosia General Hospital

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No