Critically Ill PatientsPIJNICU2NCT00773045
Pain Measurement and Pain Management in the Intensive Care Unit(ICU)
An observational study of Critically Ill Patients, run by St. Antonius Hospital.
Trial summary
The purpose of this study is to evaluate the effect of a pain training program and systematic measurement of pain scores on actual pain levels and the use of analgesics in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Patients
- What is being tested?
- A Pain training program and pain measurement
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Oct 2007
- Phase
- Observational
- 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
Study population: Critically ill patients, 18 years and older
Who may be able to join
- All patients admitted to the ICU of the St. Antonius hospital, >18 years old.
Who cannot join
- Patients who are suspected to be brain-dead
About this study
Official title: Pain Measurement and Pain Management in the ICU
The purpose of this study is to evaluate the effect of a pain training program and systematic measurement of pain scores on actual pain levels and the use of analgesics in critically ill patients.
Read the detailed description
Systematic evaluation of pain, though still not common practice in all ICUs, is recommended in clinical practice guidelines for optimal pain management. Pain is a frequently experienced problem in patients in the Intensive Care Unit(ICU). In search of literature to support the need for introduction of a pain management system and to train the entire health staff in our department little information was found concerning the effects of pain training and pain management systems in the ICU. The small number of available studies may be explained by the difficulty of systematic pain measurement in ICU patients, mainly due to the inability to communicate effectively with these patients.
- Conditions
- Critically Ill Patients
- Being tested
- A Pain training program and pain measurement
- Keywords
- pain scores, critically ill patients, ICU, pain management, pain measurement
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Pain training program and pain measurementOther
Also called pain measurement, pain management
Comparing patients treated with and without analgesia and sedation protocol
| Study group | Role | What they receive |
|---|---|---|
| pain training program | ICU Patients treated with or without pain management protocol Receives: Other: A Pain training program and pain measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores using the numerical rating scale, rated by the attending nurse and by the patient if possible.
Measured: 3 times a day
Secondary outcomes (4)
Dose of all pain medication (morphine, paracetamol) per patient
Measured: 24 hr
Length of stay in the ICU
Measured: ICU stay
Pneumonia
Measured: ICU stay
30 day Mortality
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startApr 2006
- Primary completionAug 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill PatientsStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Peter Bruins, MD, PhD, Principal investigator, Department of Anaesthesiology, Intensive Care and Pain Management, St Antonius Hospital, Nieuwegein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773045
- Sponsor's protocol ID
- PIJNICU2/Z06.11
- Acronym
- PIJNICU2
- Status last verified
- Oct 2008
- First submitted
- 15 Oct 2008
- Last updated
- 16 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Measurement and Pain Management in the ICU
- ClinicalTrials.gov ID
- NCT00773045
- Acronym / sponsor ID
- PIJNICU2 / PIJNICU2/Z06.11
- Conditions
- Critically Ill Patients
- Keywords
- pain scores, critically ill patients, ICU, pain management, pain measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 16 Oct 2008 (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 a pain training program and systematic measurement of pain scores on actual pain levels and the use of analgesics in critically ill patients.
Detailed description
Systematic evaluation of pain, though still not common practice in all ICUs, is recommended in clinical practice guidelines for optimal pain management. Pain is a frequently experienced problem in patients in the Intensive Care Unit(ICU). In search of literature to support the need for introduction of a pain management system and to train the entire health staff in our department little information was found concerning the effects of pain training and pain management systems in the ICU. The small number of available studies may be explained by the difficulty of systematic pain measurement in ICU patients, mainly due to the inability to communicate effectively with these patients.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pain training program | – | Other: A Pain training program and pain measurementICU Patients treated with or without pain management protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients, 18 years and older
Key inclusion criteria (1 listed)
- All patients admitted to the ICU of the St. Antonius hospital, >18 years old.
Key exclusion criteria (1 listed)
- Patients who are suspected to be brain-dead
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 |
|---|---|---|
| A Pain training program and pain measurementAlso: pain measurement, pain managementComparing patients treated with and without analgesia and sedation protocol | Other | pain training program |
Primary outcome
Pain scores using the numerical rating scale, rated by the attending nurse and by the patient if possible.
Time frame: 3 times a day
4 secondary outcomes
Dose of all pain medication (morphine, paracetamol) per patient
Time frame: 24 hr
Length of stay in the ICU
Time frame: ICU stay
Pneumonia
Time frame: ICU stay
30 day Mortality
Time frame: within 30 days
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 16 Oct 2008.
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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.
Peter Bruins, MD, PhD principal investigator
Department of Anaesthesiology, Intensive Care and Pain Management, St Antonius Hospital, Nieuwegein
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill Patients, run by St. Antonius Hospital.
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 16 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain scores using the numerical rating scale, rated by the attending nurse and by the patient if possible. (time frame: 3 times a day). 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 16 Oct 2008.