Pain Measurement and Pain Management in the Intensive Care Unit(ICU) - Full Text View

Sponsored by:	St. Antonius Hospital
Information provided by:	St. Antonius Hospital
ClinicalTrials.gov Identifier:	NCT00773045

Purpose

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.

Condition	Intervention
Critically Ill Patients	Other: A Pain training program and pain measurement

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Pain Measurement and Pain Management in the ICU

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:

Pain scores using the numerical rating scale, rated by the attending nurse and by the patient if possible. [ Time Frame: 3 times a day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dose of all pain medication (morphine, paracetamol) per patient [ Time Frame: 24 hr ] [ Designated as safety issue: No ]
Length of stay in the ICU [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
Pneumonia [ Time Frame: ICU stay ] [ Designated as safety issue: No ]
30 day Mortality [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	190
Study Start Date:	April 2006
Study Completion Date:	October 2007
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
pain training program ICU Patients treated with or without pain management protocol	Other: A Pain training program and pain measurement Comparing patients treated with and without analgesia and sedation protocol

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Critically ill patients, 18 years and older

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773045

Sponsors and Collaborators

St. Antonius Hospital

Investigators

Principal Investigator:

Peter Bruins, MD, PhD

Department of Anaesthesiology, Intensive Care and Pain Management, St Antonius Hospital, Nieuwegein

More Information

Responsible Party:	St Antonius Hospital ( P Bruins, MD, PhD, Department of Anaesthesiology, Intensive Care and Pain Management )
Study ID Numbers:	PIJNICU2/Z06.11
Study First Received:	October 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00773045
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by St. Antonius Hospital:

pain scores
critically ill patients
ICU
pain management
pain measurement

Study placed in the following topic categories:

Critical Illness
Pain

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009