Pain Management of Intensive Care Unit Patients

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Pain management algorithm

• Registration Number: NCT01599663
• Lead Sponsor: Ostfold Hospital Trust

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Primary Completion: 2017-05
• Status Verified: 2019-04
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention units	Pain management algorithm	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.

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation, ICU and hospital length of stay	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 Outcome Measures

Name	Time	Method
Proportion of ICU patients express having pain or are estimated to have pain. How severe their pain is.	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.
Documentation of ICU patients' pain and pain management in four ICU's.	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.
The clinician's adherence to the pain management algorithm in ICU patients.	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	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	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.

Trial Locations

Locations (1)

Ostfold Hospital Trust; 🇳🇴 Fredrikstad, Norway