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

NCT ID: NCT00558090

Last Updated: 2010-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

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

Group Type ACTIVE_COMPARATOR

morphine

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role collaborator

St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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St Antonius Hospital

Principal Investigators

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Catherijne AJ Knibbe, Pharm D

Role: PRINCIPAL_INVESTIGATOR

St Antonius Hospital, Department of Clinical Pharmacy

Locations

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St antonius Hospital

Nieuwegein, , Netherlands

Site Status

Countries

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Netherlands

References

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Goulooze SC, Krekels EH, Saleh MA, Ahlers SJ, Valitalo PA, van Dongen EP, van Schaik RH, Hankemeier T, Tibboel D, Knibbe CAJ. Predicting Unacceptable Pain in Cardiac Surgery Patients Receiving Morphine Maintenance and Rescue Doses: A Model-Based Pharmacokinetic-Pharmacodynamic Analysis. Anesth Analg. 2021 Mar 1;132(3):726-734. doi: 10.1213/ANE.0000000000005228.

Reference Type DERIVED
PMID: 33122543 (View on PubMed)

Other Identifiers

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NL18828.100.07

Identifier Type: -

Identifier Source: secondary_id

R-07.15A/OPCIC

Identifier Type: -

Identifier Source: org_study_id

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