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

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:
  • pain measurement
  • pain management

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.

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

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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