PainNCT01599663
Pain Management of Intensive Care Unit Patients
A study testing Pain management algorithm in people with Pain, run by Ostfold Hospital Trust at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Pain management algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteNorway
- Study dates
- May 2012to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consecutive patients admitted into these four ICUs
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Pain management algorithm
- Keywords
- Pain management, Pain assessment, Intensive care unit, Adult
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain management algorithmOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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.
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.
Measured: 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 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.
Measured: 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
Sedation level and use of psychoactive drugs will be measured before (pre-test) and after (post-test) the intervention.
Measured: The participants will be followed for the duration of ICU stay, an expected average of one week
Use of Analgesics
Use of analgesics will be measured before (pre-test) and after (post-test) the intervention.
Measured: The participants will be followed for the duration of ICU stay, an expected average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2017
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Brita F Olsen, Msc, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599663
- Sponsor's protocol ID
- Project number 3234
- Status last verified
- Apr 2019
- First submitted
- 4 May 2012
- Last updated
- 29 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01599663
- Acronym / sponsor ID
- Project number 3234
- Conditions
- Pain
- Keywords
- Pain management, Pain assessment, Intensive care unit, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- May 2012
- Primary completion
- May 2017 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention units | Experimental | Other: Pain management algorithmA 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consecutive patients admitted into these four ICUs
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain management algorithmThe 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. | Other | Intervention units |
Primary outcome
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
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.
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brita F Olsen, Msc principal investigator
Ostfold Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain management algorithm in people with Pain, run by Ostfold Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2019.