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

NCT00558090 | Completed

• 2 other identifiers: R-07.15A/OPCICNL18828.100.07
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

pain; Intensive Care Unit; morphine; pKpD; numerical rating scale; critically ill patients

Outcome Measures

Primary Outcomes (1)

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

  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)

  10 days

• The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay

  10 days

• The mean NRS per patient in rest during ICU stay

  10 days

• The percentage of patients with a NRS of ≥ 6 during intervention (2.5 mg versus 7.5 mg morphine iv)

  one day after admission in the ICU

• Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values)

  10 days

Study Arms (1)

A

ACTIVE COMPARATOR

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

Drug: morphine

Interventions

morphine DRUG

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

A

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to the ICU of the St. Antonius hospital, between 18-85 years old en weighing between 45-140 kg.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Antonius Hospital: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

St antonius Hospital

Nieuwegein, 3430 EM, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 33122543 DERIVED

MeSH Terms

Conditions

Critical Illness; Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Catherijne AJ Knibbe, Pharm D

  St Antonius Hospital, Department of Clinical Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: February 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 30, 2010

Record last verified: 2008-10

Locations

NL (1)