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

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. Identifier: NCT00558090
Recruitment Status : Completed
First Posted : November 14, 2007
Last Update Posted : March 30, 2010
Erasmus Medical Center
Information provided by:
St. Antonius Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critical Illness Drug: morphine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Clinical Trial of the Optimization of Procedural Pain Control in ICU Patients
Study Start Date : February 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

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
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv) [ Time Frame: 10 days ]
  2. The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay [ Time Frame: 10 days ]
  3. The mean NRS per patient in rest during ICU stay [ Time Frame: 10 days ]
  4. 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 ]
  5. Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values) [ Time Frame: 10 days ]
  6. Pharmacodynamic parameters of morphine iv (EC50 etc) [ Time Frame: 10 days ]
  7. Covariates for the PK/PD of morphine iv [ Time Frame: 10 days ]
  8. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00558090

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St antonius Hospital
Nieuwegein, Netherlands, 3430 EM
Sponsors and Collaborators
St. Antonius Hospital
Erasmus Medical Center
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Principal Investigator: Catherijne AJ Knibbe, Pharm D St Antonius Hospital, Department of Clinical Pharmacy
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Responsible Party: Dr. C.A.J. Knibbe, hospital pharmacist- clinical pharmacologist, St Antonius Hospital Identifier: NCT00558090    
Other Study ID Numbers: R-07.15A/OPCIC
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: October 2008
Keywords provided by St. Antonius Hospital:
Intensive Care Unit
numerical rating scale
critically ill patients
Additional relevant MeSH terms:
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Critical Illness
Pain, Procedural
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents