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CompletedNCT01599663Updated Apr 29, 2019

Pain Management of Intensive Care Unit Patients

An interventional study of Pain management algorithm in Pain, sponsored by Ostfold Hospital Trust. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-29.

Sponsored by Ostfold Hospital Trust · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
650
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • Pain management
  • Pain assessment
  • Intensive care unit
  • Adult
03

In context

Lead sponsor

Ostfold Hospital Trust is the lead sponsor of 48 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All consecutive patients admitted into these four ICUs

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
650 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherPain 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: The participants will be followed for the duration of hospital stay, an expected average of two weeks

Secondary outcomes

  1. 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.

    Time frame: The participants will be followed for the duration of ICU stay, an expected average of one week

  2. 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.

    Time frame: The participants will be followed for the duration of ICU stay, an expected average of one week

  3. 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.

    Time frame: The adherence will be followed for the duration of ICU stay, an expected average of one week (post-test)

  4. 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.

    Time frame: The participants will be followed for the duration of ICU stay, an expected average of one week

  5. Use of Analgesics

    Use of analgesics will be measured before (pre-test) and after (post-test) the intervention.

    Time frame: The participants will be followed for the duration of ICU stay, an expected average of one week

07

Study locations

1 site
  • Ostfold Hospital Trust
    Fredrikstad, 1603, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01599663
Lead sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital
Responsible party
Sponsor
First posted
May 16, 2012
Start date
May 2012
Primary completion
May 2017
Completion
Apr 2019
Last update
Apr 29, 2019

Study contacts

Brita F Olsen, Msc
principal investigator · Ostfold Hospital Trust

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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