Acute and Persistent Pain in ICU Patients

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Les sponsors

Tampere University Hospital

Collaborateurs

Helsinki University Central Hospital

Töölö Hospital

ESSAI CLINIQUE: NCT03432546

BioSeek: NCT03432546

Mots clés

trouble de stress post traumatique

Abstrait

Approximately 20,000 patients are treated in intensive care units (ICU) in Finland annually. During ICU stay many diagnostic and other procedures as well as immobilization and underlying diseases may cause pain. Therefore the incidence of pain in ICU patients can be high. Acute pain may cause several detrimental effects including respiratory distress, tissue hypoxia, immunosuppression and anxiety. After discharge many survivors of critical care have lower health-related quality of life, symptoms of post-traumatic stress disorder or persistent pain.

Only few studies with a focus on acute or persistent pain in ICU patients have been made, hence the incidence and risk factors for ICU-related pain is not very well known. Some of the identified risk factors for persisting pain may be increased age, sepsis or inadequate pain management during ICU stay. Opioids are most often used for analgesics in intensive care. Because they may have several adverse effects the use must be based on validated pain scales. Many factors such as sedation, relaxation or delirium of the patient complicates the management of the pain.

This prospective observational study aims to determine the incidence and risk factors for acute and persistent pain in ICU patients as well as and the use of analgesics during intensive care.

Rendez-vous

Dernière vérification:	09/30/2019
Première soumission:	12/19/2017
Inscription estimée soumise:	02/06/2018
Première publication:	02/13/2018
Dernière mise à jour soumise:	10/20/2019
Dernière mise à jour publiée:	10/21/2019
Date de début réelle de l'étude:	04/05/2018
Date d'achèvement primaire estimée:	11/30/2028
Date estimée d'achèvement de l'étude:	11/30/2029

Condition ou maladie

Critical Care

Acute Pain

Chronic Pain

Intervention / traitement

Other: ICU patients

Phase

Groupes d'armes

Bras	Intervention / traitement
ICU patients Over 18-year old intensive care patients, non-interventional prospective observational study	Other: ICU patients Non-interventional

Critère d'éligibilité

Âges éligibles aux études	18 Years À 18 Years
Sexes éligibles à l'étude	All
Méthode d'échantillonnage	Non-Probability Sample
Accepte les bénévoles en santé	Oui
Critères	Inclusion Criteria: - not meeting the exclusion criteria Exclusion Criteria: - pregnant patients - age under 18 years - suffering from significant brain injury - elective neurosurgical patients - probable organ donors - suffering from significant cognitive impairment - presumed death under 48h

Résultat

Mesures des résultats primaires

1. Incidence of acute pain [Through study completion, an average of 3 days]

Moderate or severe pain (numerical rating scale (NRS) value above 3 / critical pain observatory tool (CPOT) value ≥3) during intensive care

2. Incidence of persistent neuropathic pain using Pain Detect [At intensive care follow up clinic at three months after discharge and thereafter the change in pain annually for 5 years]

Moderate or severe pain.

3. Incidence of anxiety affecting persistent pain [At intensive care follow up clinic at three months after discharge and thereafter the change in anxiety annually for 5 years]

State Trait anxiety Index T (STAI-T)

Mesures des résultats secondaires

1. Analgesic use [Through study completion, an average of 3 days]

Analgesics administered during intensive care including indications and dosages

2. Delirium [Through study completion, an average of 3 days]

Incidence of delirium during intensive care by using Intensive Care Delirium Screening Checklist (ICDSC, scores 0-8) scale, a sum of symptoms equal or above 4 is considered affirmative for delirium

Acute and Persistent Pain in ICU Patients

Mots clés

anxiété

trouble de stress post traumatique

sepsis

hypoxie

syndrome confusionnel

antalgique