Pain Management of Intensive Care Unit Patients

Pain Management of Intensive Care Unit (ICU) Patients. An Intervention Study to Evaluate the Effect of Systematic Pain Management of Various Groups of ICU Patients.

The purpose of this study is to evaluate the effect of an algorithm, where ICU patients pain are assessed systematically with valid pain assessment tools and where pain is treated after pain intensity score.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Pain management algorithm

Detailed Description

As a pre-test, before the intervention is introduced, data from ICU patients from four intensive care units (ICU) will be collected from medical records to evaluate current pain management practices. An algorithm, which is developed by a group of resource persons, is educated to the staff in three of the ICUs. The staff will also receive training and guiding in the use of the algorithm and the different pain assessment tools. Then the algorithm will be implemented and used in all the consecutive ICU patients. Post-test data is then collected in the three ICUs. In the fourth ICU, which will be used as a comparison unit, the same post-test data will be collected at the same time as data in intervention ICUs were collected. The algorithm will not be introduced here.

• Study Type: Interventional
• Enrollment (Actual): 650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Fredrikstad, Norway, 1603
    • Ostfold Hospital Trust

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:

• All consecutive patients admitted into these four ICUs

Exclusion Criteria:

• Patients will be excluded if they are not able to express pain behaviors (i.e. quadriplegic, are receiving neuromuscular blockade or muscle paralyzing drugs or are being investigated for brain death.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention units; A time period before the clinicians will be educated, trained and guided in the pain management algorithm, pre-test data will be collected in four ICU units. The clinicians in three of the ICU units will be educated, trained and guided in the pain management algorithm. The algorithm will then be used to assess and treat pain in all consecutive ICU patients. Post-test data will be collected a time period after the intervention is implemented.	Other: Pain management algorithm; The algorithm guide the clinicians to score ICU patients pain systematically with different pain assessment tools. The tools are the Numeric Rating Scale, Behavioral Pain Scale and Behavioral Pain Scale Non Intubated. The algorithm guide the clinicians to choose between the different pain assessment tools depending on the ICU patient's condition and ability to rate his own pain. Thereafter the algorithm guide the clinicians to treat pain depending on the pain intensity score.
No Intervention: Control unit; The clinicians in the fourth ICU (control unit) will not be educated, trained and guided in the pain management algorithm. They will continue to assess and treat pain in all consecutive ICU patients as before. The unit, which will be used as a comparison unit, will collect the same post-test data at the same time as data in intervention ICUs were collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation, ICU and hospital length of stay	Duration of mechanical ventilation, ICU and hospital length of stay will be measured in a group of ICU patients before (pre-test) and after (post-test) the intervention.	The participants will be followed for the duration of hospital stay, an expected average of two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Documentation of ICU patients' pain and pain management in four ICU's.	The data is collected to evaluate current pain and pain management practices in a period before the intervention is implemented (pre-test). The data is collected from both intervention units and control unit.	The participants will be followed for the duration of ICU stay, an expected average of one week
Proportion of ICU patients express having pain or are estimated to have pain. How severe their pain is.	In the pre-test, the medical records are searched for use of different pain assessment tools or other notations about pain assessment of these patients. In the post-test the medical records are searched for systematically pain intensity scores from the different pain assessment tools.	The participants will be followed for the duration of ICU stay, an expected average of one week
The clinician's adherence to the pain management algorithm in ICU patients.	The medical records will be searched for documentation of how the algorithm is used. I.e. is it used to the right patients, Is it used as often as described, is it used to the right patients.	The adherence will be followed for the duration of ICU stay, an expected average of one week (post-test)
Sedation level and Use of psychoactive drugs	Sedation level and use of psychoactive drugs will be measured before (pre-test) and after (post-test) the intervention.	The participants will be followed for the duration of ICU stay, an expected average of one week
Use of Analgesics	Use of analgesics will be measured before (pre-test) and after (post-test) the intervention.	The participants will be followed for the duration of ICU stay, an expected average of one week

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: Oslo University Hospital
• Investigators: Principal Investigator: Brita F Olsen, Msc, Ostfold Hospital Trust

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: May 4, 2012
• First Submitted That Met QC Criteria: May 15, 2012
• First Posted (Estimate): May 16, 2012

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Pain management; Adult; Intensive care unit; Pain assessment
• Other Study ID Numbers: Project number 3234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No