Pain Management of Intensive Care Unit Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT01599663
First received: May 4, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Pain
Other: Pain management algorithm

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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.

Further study details as provided by Ostfold Hospital Trust:

Primary Outcome Measures:
  • Duration of mechanical ventilation, ICU and hospital length of stay [ Time Frame: The participants will be followed for the duration of hospital stay, an expected average of two weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Documentation of ICU patients' pain and pain management in four ICU's. [ Time Frame: The participants will be followed for the duration of ICU stay, an expected average of one week ] [ Designated as safety issue: No ]
    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.

  • Proportion of ICU patients express having pain or are estimated to have pain. How severe their pain is. [ Time Frame: The participants will be followed for the duration of ICU stay, an expected average of one week ] [ Designated as safety issue: No ]
    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 clinician's adherence to the pain management algorithm in ICU patients. [ Time Frame: The adherence will be followed for the duration of ICU stay, an expected average of one week (post-test) ] [ Designated as safety issue: No ]
    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.

  • Sedation level and Use of psychoactive drugs [ Time Frame: The participants will be followed for the duration of ICU stay, an expected average of one week ] [ Designated as safety issue: No ]
    Sedation level and use of psychoactive drugs will be measured before (pre-test) and after (post-test) the intervention.

  • Use of Analgesics [ Time Frame: The participants will be followed for the duration of ICU stay, an expected average of one week ] [ Designated as safety issue: No ]
    Use of analgesics will be measured before (pre-test) and after (post-test) the intervention.


Estimated Enrollment: 720
Study Start Date: May 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599663

Locations
Norway
Ostfold Hospital Trust
Fredrikstad, Norway, 1603
Sponsors and Collaborators
Ostfold Hospital Trust
Oslo University Hospital
Investigators
Principal Investigator: Brita F Olsen, Msc Ostfold Hospital Trust
  More Information

No publications provided

Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT01599663     History of Changes
Other Study ID Numbers: Project number 3234
Study First Received: May 4, 2012
Last Updated: November 18, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Ostfold Hospital Trust:
Pain management
Pain assessment
Intensive care unit
Adult

ClinicalTrials.gov processed this record on August 01, 2014