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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
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
St antonius Hospital
Nieuwegein, Netherlands
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
The mean NRS during an intervention (2.5 mg versus 7.5 mg morphine iv)
Time frame: 10 days
The percentage of patients with at least one NRS-score of ≥ 4 at rest during ICU stay
Time frame: 10 days
The mean NRS per patient in rest during ICU stay
Time frame: 10 days
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
Pharmacokinetic parameters of morphine iv (volumes of distribution and clearance values)
Time frame: 10 days
Pharmacodynamic parameters of morphine iv (EC50 etc)
Time frame: 10 days
Covariates for the PK/PD of morphine iv
Time frame: 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.
Time frame: 10 days
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