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Completed

NCT Number: NCT01599663

Pain Management of Intensive Care Unit 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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ostfold Hospital Trust

Fredrikstad, 1603, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain management algorithm

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2017
Study completion
2019
First posted
May 16, 2012
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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