Pain Management of Intensive Care Unit Patients

NCT ID: NCT01599663

Last Updated: 2019-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pain management algorithm

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brita F Olsen, Msc

Role: PRINCIPAL_INVESTIGATOR

Ostfold Hospital Trust

Locations

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Ostfold Hospital Trust

Fredrikstad, , Norway

Site Status

Countries

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Norway

Other Identifiers

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Project number 3234

Identifier Type: -

Identifier Source: org_study_id

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