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

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
morphine
Sponsored by
St. Antonius Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring pain, Intensive Care Unit, morphine, pKpD, numerical rating scale, critically ill patients

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St antonius Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

patients receive 2,5 mg morphine iv, before the first intervention on the day after admission in the ICU

Outcomes

Primary Outcome Measures

The percentage of patients with a NRS of ≥ 4 during intervention (2.5 mg versus 7.5 mg morphine iv)

Secondary Outcome Measures

The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv)
The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay
The mean NRS per patient in rest during ICU stay
The percentage of patients with a NRS of ≥ 6 during intervention (2.5 mg versus 7.5 mg morphine iv)
Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values)
Pharmacodynamic parameters of morphine iv (EC50 etc)
Covariates for the PK/PD of morphine iv
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.

Full Information

First Posted
November 13, 2007
Last Updated
March 29, 2010
Sponsor
St. Antonius Hospital
Collaborators
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00558090
Brief Title
The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients
Acronym
OPCIC
Official Title
Randomised Clinical Trial of the Optimization of Procedural Pain Control in ICU Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Antonius Hospital
Collaborators
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
pain, Intensive Care Unit, morphine, pKpD, numerical rating scale, critically ill patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
patients receive 2,5 mg morphine iv, before the first intervention on the day after admission in the ICU
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv)
Time Frame
10 days
Title
The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay
Time Frame
10 days
Title
The mean NRS per patient in rest during ICU stay
Time Frame
10 days
Title
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
Title
Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values)
Time Frame
10 days
Title
Pharmacodynamic parameters of morphine iv (EC50 etc)
Time Frame
10 days
Title
Covariates for the PK/PD of morphine iv
Time Frame
10 days
Title
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. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherijne AJ Knibbe, Pharm D
Organizational Affiliation
St Antonius Hospital, Department of Clinical Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
St antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
33122543
Citation
Goulooze SC, Krekels EH, Saleh MA, Ahlers SJ, Valitalo PA, van Dongen EP, van Schaik RH, Hankemeier T, Tibboel D, Knibbe CAJ. Predicting Unacceptable Pain in Cardiac Surgery Patients Receiving Morphine Maintenance and Rescue Doses: A Model-Based Pharmacokinetic-Pharmacodynamic Analysis. Anesth Analg. 2021 Mar 1;132(3):726-734. doi: 10.1213/ANE.0000000000005228.
Results Reference
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The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients

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