- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00773045
Pain Measurement and Pain Management in the Intensive Care Unit(ICU) (PIJNICU2)
October 15, 2008 updated by: St. Antonius Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
190
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Critically ill patients, 18 years and older
Description
Inclusion Criteria:
- All patients admitted to the ICU of the St. Antonius hospital, >18 years old.
Exclusion Criteria:
- Patients who are suspected to be brain-dead
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
pain training program
ICU Patients treated with or without pain management protocol
|
Comparing patients treated with and without analgesia and sedation protocol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain scores using the numerical rating scale, rated by the attending nurse and by the patient if possible.
Time Frame: 3 times a day
|
3 times a day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose of all pain medication (morphine, paracetamol) per patient
Time Frame: 24 hr
|
24 hr
|
Length of stay in the ICU
Time Frame: ICU stay
|
ICU stay
|
Pneumonia
Time Frame: ICU stay
|
ICU stay
|
30 day Mortality
Time Frame: within 30 days
|
within 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Bruins, MD, PhD, Department of Anaesthesiology, Intensive Care and Pain Management, St Antonius Hospital, Nieuwegein
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
October 15, 2008
First Submitted That Met QC Criteria
October 15, 2008
First Posted (Estimate)
October 16, 2008
Study Record Updates
Last Update Posted (Estimate)
October 16, 2008
Last Update Submitted That Met QC Criteria
October 15, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIJNICU2/Z06.11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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