NCT00773045

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

Enrollment Period

4 months

First QC Date

October 15, 2008

Last Update Submit

October 15, 2008

Conditions

Critically Ill Patients

Keywords

pain scorescritically ill patientsICUpain managementpain measurement

Outcome Measures

Primary Outcomes (1)

  • Pain scores using the numerical rating scale, rated by the attending nurse and by the patient if possible.

    3 times a day

Secondary Outcomes (4)

  • Dose of all pain medication (morphine, paracetamol) per patient

    24 hr

  • Length of stay in the ICU

    ICU stay

  • Pneumonia

    ICU stay

  • 30 day Mortality

    within 30 days

Study Arms (1)

pain training program

ICU Patients treated with or without pain management protocol

Other: A Pain training program and pain measurement

Interventions

A Pain training program and pain measurementOTHER

Comparing patients treated with and without analgesia and sedation protocol

Also known as: pain measurement, pain management
pain training program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients, 18 years and older

You may qualify if:

  • All patients admitted to the ICU of the St. Antonius hospital, \>18 years old.

You may not qualify if:

  • Patients who are suspected to be brain-dead

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Agnosia

Interventions

Pain Management

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsDisease ManagementPatient Care ManagementHealth Services Administration

Study Officials

  • Peter Bruins, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 16, 2008

Study Start

April 1, 2006

Primary Completion

August 1, 2006

Study Completion

October 1, 2007

Last Updated

October 16, 2008

Record last verified: 2008-10