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The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients (OPCIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00558090
First Posted: November 14, 2007
Last Update Posted: March 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Erasmus Medical Center
Information provided by:
St. Antonius Hospital
November 13, 2007
November 14, 2007
March 30, 2010
February 2008
February 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00558090 on ClinicalTrials.gov Archive Site
  • The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv) [ Time Frame: 10 days ]
  • The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay [ Time Frame: 10 days ]
  • The mean NRS per patient in rest during ICU stay [ Time Frame: 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 ]
  • Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values) [ Time Frame: 10 days ]
  • Pharmacodynamic parameters of morphine iv (EC50 etc) [ Time Frame: 10 days ]
  • Covariates for the PK/PD of morphine iv [ Time Frame: 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 ]
Same as current
Not Provided
Not Provided
 
The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Critical Illness
Drug: morphine
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
Active Comparator: A
patients receive 2,5 mg morphine iv, before the first intervention on the day after admission in the ICU
Intervention: Drug: morphine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2010
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00558090
R-07.15A/OPCIC
NL18828.100.07
No
Not Provided
Not Provided
Dr. C.A.J. Knibbe, hospital pharmacist- clinical pharmacologist, St Antonius Hospital
St. Antonius Hospital
Erasmus Medical Center
Principal Investigator: Catherijne AJ Knibbe, Pharm D St Antonius Hospital, Department of Clinical Pharmacy
St. Antonius Hospital
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP