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

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Drug: morphine

• Registration Number: NCT00558090
• Lead Sponsor: St. Antonius Hospital

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.

Study Timeline

• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-13
• Study First Posted: 2007-11-14
• Study Start: 2008-02
• Status Verified: 2008-10
• Primary Completion: 2009-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-03-29
• Last Update Posted: 2010-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values)	10 days
Pharmacodynamic parameters of morphine iv (EC50 etc)	10 days
Covariates for the PK/PD of morphine iv	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.	10 days
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

Trial Locations

Locations (1)

St antonius Hospital; 🇳🇱 Nieuwegein, Netherlands