Clinical trial NCT00558090: The Optimization of Procedural Pain Control in Intensive Care Unit (ICU) Patients
Official title: Randomised Clinical Trial of the Optimization of Procedural Pain Control in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: pain
Intensive Care Unit
morphine
pKpD
numerical rating scale
critically ill patients
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2007-11-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The percentage of patients with a NRS of ≥ 4 during intervention (2.5 mg versus 7.5 mg morphine iv)
timeFrame: The first intervention one day after admission
Secondary outcomes:
measure: The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv)
timeFrame: 10 days
measure: The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay
timeFrame: 10 days
measure: The mean NRS per patient in rest during ICU stay
timeFrame: 10 days
measure: The percentage of patients with a NRS of ≥ 6 during intervention (2.5 mg versus 7.5 mg morphine iv)
timeFrame: one day after admission in the ICU
measure: Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values)
timeFrame: 10 days
measure: Pharmacodynamic parameters of morphine iv (EC50 etc)
timeFrame: 10 days
measure: Covariates for the PK/PD of morphine iv
timeFrame: 10 days
measure: 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.
timeFrame: 10 days
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St antonius Hospital
Study officials:
affiliation: St Antonius Hospital, Department of Clinical Pharmacy
name: Catherijne AJ Knibbe, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
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.