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Pain Management of Intensive Care Unit Patients

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ClinicalTrials.gov Identifier: NCT01599663
Recruitment Status : Active, not recruiting
First Posted : May 16, 2012
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

May 4, 2012
May 16, 2012
December 6, 2017
May 2012
May 2017   (Final data collection date for primary outcome measure)
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 ]
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.
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 ]
Duration of mechanical ventilation, ICU and hospital lenght of stay will be measured in a group of ICU patients before (pre-test) and after (post-test) the intervention.
Complete list of historical versions of study NCT01599663 on ClinicalTrials.gov Archive Site
  • 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 ]
    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 ]
    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) ]
    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 ]
    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 ]
    Use of analgesics will be measured before (pre-test) and after (post-test) the intervention.
Same as current
Not Provided
Not Provided
 
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.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Pain
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.
  • 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.

    Intervention: Other: Pain management algorithm
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
720
October 2018
May 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01599663
Project number 3234
Yes
Not Provided
Plan to Share IPD: No
Ostfold Hospital Trust
Ostfold Hospital Trust
Oslo University Hospital
Principal Investigator: Brita F Olsen, Msc Ostfold Hospital Trust
Ostfold Hospital Trust
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP