Overview

This trial is active, not recruiting.

Condition pain
Treatment pain management algorithm
Sponsor Ostfold Hospital Trust
Collaborator Oslo University Hospital
Start date May 2012
End date March 2016
Trial size 720 participants
Trial identifier NCT01599663, Project number 3234

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(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.
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.
(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.

Primary Outcomes

Measure
Duration of mechanical ventilation, ICU and hospital length of stay
time frame: The participants will be followed for the duration of hospital stay, an expected average of two weeks

Secondary Outcomes

Measure
Documentation of ICU patients' pain and pain management in four ICU's.
time frame: 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.
time frame: 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.
time frame: 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
time frame: The participants will be followed for the duration of ICU stay, an expected average of one week
Use of Analgesics
time frame: The participants will be followed for the duration of ICU stay, an expected average of one week

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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.
Principal investigator Brita F Olsen, Msc
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Ostfold Hospital Trust.