The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients (OPCIC)
March 29, 2010 updated by: St. Antonius Hospital
Randomised Clinical Trial of the Optimization of Procedural Pain Control in ICU Patients
The purpose of this study is to determine the influence of morphine 2,5 mg or morphine 7,5 mg iv during a painful and unavoidable intervention in critically ill patients.
Study Overview
Detailed Description
In 2006, in the Intensive Care Unit (ICU) of the St. Antonius Hospital an analgesia improvement program has been implemented.
This program consisted of training of ICU nurses and intensivists using a hospital based standardized pain protocol, and systematic pain measurements in rest, rated by the patient himself whenever possible or otherwise by the attending nurse.
This program has resulted in a reduction of severe pain levels (NRS≥4) in ICU patients in rest from 41% to 22%.
In order to further reduce this percentage, a pain titration protocol is introduced in 2007.
As no attention has yet been paid to intervention-related pain levels in these patients, in this prospective study pain control will be studied using different analgesic dosages of morphine iv (2,5 mg vs 7,5 mg) around unavoidable painful interventions within a pain titration protocol for pain control in rest.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nieuwegein, Netherlands, 3430 EM
- St Antonius hospital
-
-
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 to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients admitted to the ICU of the St. Antonius hospital, between 18-85 years old en weighing between 45-140 kg.
Exclusion Criteria:
- Pregnancy/ breastfeeding
- Language barrier
- Known morphine iv allergy
- Comatose patients (cooled)
- Patients who are suspected to be brain-dead
- Unintubated patients on the verge of intubation due to respiratory insufficiency
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: A
patients receive 2,5 mg morphine iv, before the first intervention on the day after admission in the ICU
|
patients receive 7,5 mg morphine iv 30 minutes before intervention (turning of the patient), the day after admission in the ICU.
before, during and after, the patient will be asked to rate the pain using the NRS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The percentage of patients with a NRS of ≥ 4 during intervention (2.5 mg versus 7.5 mg morphine iv)
Time Frame: The first intervention one day after admission
|
The first intervention one day after admission
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv)
Time Frame: 10 days
|
10 days
|
|
The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay
Time Frame: 10 days
|
10 days
|
|
The mean NRS per patient in rest during ICU stay
Time Frame: 10 days
|
10 days
|
|
The percentage of patients with a NRS of ≥ 6 during intervention (2.5 mg versus 7.5 mg morphine iv)
Time Frame: one day after admission in the ICU
|
one day after admission in the ICU
|
|
Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values)
Time Frame: 10 days
|
10 days
|
|
Pharmacodynamic parameters of morphine iv (EC50 etc)
Time Frame: 10 days
|
10 days
|
|
Covariates for the PK/PD of morphine iv
Time Frame: 10 days
|
10 days
|
|
Safety and other measures of the analgesics (morphine iv and paracetamol) used for intervention related pain as well as pain titration protocol for pain control in rest.
Time Frame: 10 days
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Catherijne AJ Knibbe, Pharm D, St Antonius Hospital, Department of Clinical Pharmacy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
February 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
November 13, 2007
First Submitted That Met QC Criteria
November 13, 2007
First Posted (Estimate)
November 14, 2007
Study Record Updates
Last Update Posted (Estimate)
March 30, 2010
Last Update Submitted That Met QC Criteria
March 29, 2010
Last Verified
October 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-07.15A/OPCIC
- NL18828.100.07
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.