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Completed

NCT Number: NCT00558090

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St antonius Hospital

Nieuwegein, 3430 EM, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: The first intervention one day after admission

Secondary outcomes

  1. The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv)

    Time frame: 10 days

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

    Time frame: 10 days

  3. The mean NRS per patient in rest during ICU stay

    Time frame: 10 days

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

    Time frame: one day after admission in the ICU

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

    Time frame: 10 days

  6. Pharmacodynamic parameters of morphine iv (EC50 etc)

    Time frame: 10 days

  7. Covariates for the PK/PD of morphine iv

    Time frame: 10 days

  8. 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.

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

St. Antonius Hospital

Other

Collaborators

  • Erasmus Medical Center

Registry information

Official study title

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

Acronym: OPCIC

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Nov 14, 2007
Registry last updated
Mar 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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