Critical IllnessOPCICNCT00558090
The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients
A study testing morphine in people with Critical Illness, run by St. Antonius Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the ICU of the St. Antonius hospital, between 18-85 years old en weighing between 45-140 kg.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- morphine
- Keywords
- pain, Intensive Care Unit, morphine, pKpD, numerical rating scale, critically ill patients
- Medical subject headings
- Critical Illness, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | patients receive 2,5 mg morphine iv, before the first intervention on the day after admission in the ICU Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with a NRS of ≥ 4 during intervention (2.5 mg versus 7.5 mg morphine iv)
Measured: The first intervention one day after admission
Secondary outcomes (8)
The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv)
Measured: 10 days
The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay
Measured: 10 days
The mean NRS per patient in rest during ICU stay
Measured: 10 days
The percentage of patients with a NRS of ≥ 6 during intervention (2.5 mg versus 7.5 mg morphine iv)
Measured: one day after admission in the ICU
Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values)
Measured: 10 days
Pharmacodynamic parameters of morphine iv (EC50 etc)
Measured: 10 days
Covariates for the PK/PD of morphine iv
Measured: 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.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Investigators
- Catherijne AJ Knibbe, Pharm D, Principal investigator, St Antonius Hospital, Department of Clinical Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558090
- Sponsor's protocol ID
- R-07.15A/OPCIC
- Other IDs
- NL18828.100.07
- Acronym
- OPCIC
- Status last verified
- Oct 2008
- First submitted
- 13 Nov 2007
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33122543
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial of the Optimization of Procedural Pain Control in ICU Patients
- ClinicalTrials.gov ID
- NCT00558090
- Acronym / sponsor ID
- OPCIC / R-07.15A/OPCIC
- Conditions
- Critical Illness
- Keywords
- pain, Intensive Care Unit, morphine, pKpD, numerical rating scale, critically ill patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: morphinepatients receive 2,5 mg morphine iv, before the first intervention on the day after admission in the ICU |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the ICU of the St. Antonius hospital, between 18-85 years old en weighing between 45-140 kg.
Key exclusion criteria (6 listed)
- Pregnancy/ breastfeeding
- Language barrier
- Known morphine iv allergy
- Comatose patients (cooled)
- Patients who are suspected to be brain-dead
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morphinepatients 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 | Drug | A |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
- Derived from this study: PubMed 33122543Goulooze 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.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherijne AJ Knibbe, Pharm D principal investigator
St Antonius Hospital, Department of Clinical Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing morphine in people with Critical Illness, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00558090, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2010.