Pain Management of Intensive Care Unit Patients

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599663
• Other study ID #: Project number 3234
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: April 2019
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust	Fredrikstad

Sponsors (2)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The participants will be followed for the duration of hospital stay, an expected average of two weeks
Secondary	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.	The participants will be followed for the duration of ICU stay, an expected average of one week
Secondary	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.	The participants will be followed for the duration of ICU stay, an expected average of one week
Secondary	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.	The adherence will be followed for the duration of ICU stay, an expected average of one week (post-test)
Secondary	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.	The participants will be followed for the duration of ICU stay, an expected average of one week
Secondary	Use of Analgesics	Use of analgesics will be measured before (pre-test) and after (post-test) the intervention.	The participants will be followed for the duration of ICU stay, an expected average of one week