Pain Management of Intensive Care Unit Patients
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| First Received Date ICMJE | May 4, 2012 | ||||||||
| Last Updated Date | October 1, 2012 | ||||||||
| Start Date ICMJE | May 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] Duration of mechanical ventilation, ICU and hospital lenght of stay will be measured in a group of ICU patients before (pre-test) and after (post-test) the intervention. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01599663 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pain Management of Intensive Care Unit Patients | ||||||||
| Official Title ICMJE | 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. | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Pain | ||||||||
| Intervention ICMJE | 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. |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 720 | ||||||||
| Estimated Completion Date | October 2015 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01599663 | ||||||||
| Other Study ID Numbers ICMJE | Project number 3234 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Ostfold Hospital Trust | ||||||||
| Study Sponsor ICMJE | Ostfold Hospital Trust | ||||||||
| Collaborators ICMJE | Oslo University Hospital | ||||||||
| Investigators ICMJE |
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| Information Provided By | Ostfold Hospital Trust | ||||||||
| Verification Date | October 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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