Pain Management of Intensive Care Unit Patients

NCT01599663 | Completed DMC

• 1 other identifier: Project number 3234
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain management; Pain assessment; Intensive care unit; Adult

Outcome Measures

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.

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

Secondary Outcomes (5)

• 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

• 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

• 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)

• Sedation level and Use of psychoactive drugs

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

• Use of Analgesics

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

Study Arms (2)

Intervention units

EXPERIMENTAL

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

Control unit

NO INTERVENTION

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

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.

Intervention units

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients admitted into these four ICUs

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Oslo University Hospital: collaborator

Study Sites (1)

Ostfold Hospital Trust

Fredrikstad, 1603, Norway

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Brita F Olsen, Msc

  Ostfold Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 16, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: April 1, 2019
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)