Clinical trial NCT01599663: Pain Management of Intensive Care Unit Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Pain management
Pain assessment
Intensive care unit
Adult
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2012-05-16
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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.

Primary outcomes:
measure: Duration of mechanical ventilation, ICU and hospital length of stay
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of two weeks
Secondary outcomes:
measure: Documentation of ICU patients' pain and pain management in four ICU's.
timeFrame: The participants will be followed for the duration of ICU stay, an expected average of one week
measure: Proportion of ICU patients express having pain or are estimated to have pain. How severe their pain is.
timeFrame: The participants will be followed for the duration of ICU stay, an expected average of one week
measure: The clinician's adherence to the pain management algorithm in ICU patients.
timeFrame: The adherence will be followed for the duration of ICU stay, an expected average of one week (post-test)
measure: Sedation level and Use of psychoactive drugs
timeFrame: The participants will be followed for the duration of ICU stay, an expected average of one week
measure: Use of Analgesics
timeFrame: The participants will be followed for the duration of ICU stay, an expected average of one week
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
facility: Ostfold Hospital Trust
Study officials:
affiliation: Ostfold Hospital Trust
name: Brita F Olsen, Msc
role: PRINCIPAL_INVESTIGATOR
References: