The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients - Full Text View

Sponsors and Collaborators:	St. Antonius Hospital Erasmus Medical Center
Information provided by:	St. Antonius Hospital
ClinicalTrials.gov Identifier:	NCT00558090

Purpose

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	Intervention
Critical Illness	Drug: morphine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomised Clinical Trial of the Optimization of Procedural Pain Control in ICU Patients

Further study details as provided by St. Antonius Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay [ Time Frame: 10 days ] [ Designated as safety issue: No ]
The mean NRS per patient in rest during ICU stay [ Time Frame: 10 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Pharmacodynamic parameters of morphine iv (EC50 etc) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Covariates for the PK/PD of morphine iv [ Time Frame: 10 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	February 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558090

Contacts

Contact: Sabine Ahlers, Msc

s.ahlers@antonius.net

Locations

Netherlands
St antonius Hospital	Recruiting
Nieuwegein, Netherlands, 3430 EM

Sponsors and Collaborators

St. Antonius Hospital

Erasmus Medical Center

Investigators

Principal Investigator:

Catherijne AJ Knibbe, Pharm D

St Antonius Hospital, Department of Clinical Pharmacy

More Information

Responsible Party:	St Antonius Hospital ( Dr. C.A.J. Knibbe, hospital pharmacist- clinical pharmacologist )
Study ID Numbers:	R-07.15A/OPCIC, NL18828.100.07
Study First Received:	November 13, 2007
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00558090
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by St. Antonius Hospital:

pain
Intensive Care Unit
morphine

pKpD
numerical rating scale
critically ill patients

Study placed in the following topic categories:

Morphine
Critical Illness
Pain

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009