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

Critical Illness Clinical Trial

— OPCIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00558090
• Other study ID #: R-07.15A/OPCIC
• Secondary ID: NL18828.100.07
• Status: Completed
• Phase: N/A
• First received: November 13, 2007
• Last updated: March 29, 2010
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: October 2008
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• morphine
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

Locations

Country	Name	City	State
Netherlands	St antonius Hospital	Nieuwegein

Sponsors (2)

Lead Sponsor	Collaborator
St. Antonius Hospital	Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv)		10 days	No
Secondary	The percentage of patients with at least one NRS-score of = 4 at rest during ICU stay		10 days	No
Secondary	The mean NRS per patient in rest during ICU stay		10 days	No
Secondary	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	No
Secondary	Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values)		10 days	No
Secondary	Pharmacodynamic parameters of morphine iv (EC50 etc)		10 days	No
Secondary	Covariates for the PK/PD of morphine iv		10 days	No
Secondary	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	Yes