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

Condition(s) targeted: Critical Illness

Intervention: morphine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: St. Antonius Hospital

Official(s) and/or principal investigator(s):
Catherijne AJ Knibbe, Pharm D, Principal Investigator, Affiliation: St Antonius Hospital, Department of Clinical Pharmacy

Overall contact:
Sabine Ahlers, Msc, Email: s.ahlers@antonius.net

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.

Official title: Randomised Clinical Trial of the Optimization of Procedural Pain Control in ICU Patients

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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.

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.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Sabine Ahlers, Msc, Email: s.ahlers@antonius.net

St antonius Hospital, Nieuwegein 3430 EM, Netherlands; Recruiting

Starting date: February 2008
Ending date: October 2008
Last updated: October 14, 2008