Validation of methods for monitoring nociception and pain prediction in the ICU

Validation of methods for monitoring nociception and pain prediction in the ICU - ValidPainScore-ICU

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011206

Enrollment

1100

Registered

2017-01-11

Start date

2017-01-11

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R52.0 R52.2

Interventions

Group 1: We investigate data about the pupillary dilation reflex, the nociceptive flexion reflex and various clinical pain scores obtained from intensive care patients that are unable to communicate t

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - mechanically ventilated patients in intensive care units - unable to communicate pain level due to sedation or impared consciousness - potentially painfull diagnostic or therapeutic interventions during routine care

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
1. Difference in duration of mechnical ventilation between sedated intensive care patients showing nociceptive reactions to painful procedures compared to similar patients without nociceptive reactions.	—

Secondary

Measure	Time frame
2. Difference in duration of ICU stay and rates of infections, delirium, chronic pain and post-traumatic stress disorder between patients showing nociceptive responses during potentially painful procedures and patients without such responses. 3. Correlation of the threshold of the nociceptive flexion reflex (NFRT), the threshold of the pupillary dilation reflex (PDRT), the Nociception-Level-Index (NOL), the Patient-State-Index (PSI), othher EEG-indices for sedation and the concentrations of analgesics and sedatives directly before and during potentially painful procedures with the occurrence of nociceptive responses during the procedures. 4. Correlation of the threshold of the nociceptive flexion reflex (NFRT), the threshold of the pupillary dilation reflex (PDRT), the Nociception-Level-Index (NOL), the Patient-State-Index (PSI), othher EEG-indices for sedation and the concentrations of analgesics and sedatives directly before and during potentially painful procedures with the duration of mechanical ventilation, the duration of ICU stay and rates of infections, delirium, chronic pain and post-traumatic stress disorder. 5. Correlation of the change in Nociception-Level-Index (NOL), Patient-State-Index (PSI) and other EEG-derived sedation-paramter by painfull intervention with the occurrence of nociceptive responses during the procedures and analgesic or sedetativ medication. 6. Differences in the correlations of the secondary outcomes 3, 4 and 5 between patients with lesions of the central nervous system and patients without such lesions. 7. Interrater reliability of clinical pain scores (Behavorial Pain Scale, PAIN Algorithm, Pain Behavior Observation Tool, Critical Care Pain Observation Tool, Nociception Coma Scale, Nonverbal Pain Assessment Tool, Cardiac Analgesic Assessment Scale) directly before and during potentially painful procedures. 8. Difference in measurement precision and duration between different algorithms to estimate the pupillary dilatio	—

Measure

Time frame

2. Difference in duration of ICU stay and rates of infections, delirium, chronic pain and post-traumatic stress disorder between patients showing nociceptive responses during potentially painful procedures and patients without such responses. 3. Correlation of the threshold of the nociceptive flexion reflex (NFRT), the threshold of the pupillary dilation reflex (PDRT), the Nociception-Level-Index (NOL), the Patient-State-Index (PSI), othher EEG-indices for sedation and the concentrations of analgesics and sedatives directly before and during potentially painful procedures with the occurrence of nociceptive responses during the procedures. 4. Correlation of the threshold of the nociceptive flexion reflex (NFRT), the threshold of the pupillary dilation reflex (PDRT), the Nociception-Level-Index (NOL), the Patient-State-Index (PSI), othher EEG-indices for sedation and the concentrations of analgesics and sedatives directly before and during potentially painful procedures with the duration of mechanical ventilation, the duration of ICU stay and rates of infections, delirium, chronic pain and post-traumatic stress disorder. 5. Correlation of the change in Nociception-Level-Index (NOL), Patient-State-Index (PSI) and other EEG-derived sedation-paramter by painfull intervention with the occurrence of nociceptive responses during the procedures and analgesic or sedetativ medication. 6. Differences in the correlations of the secondary outcomes 3, 4 and 5 between patients with lesions of the central nervous system and patients without such lesions. 7. Interrater reliability of clinical pain scores (Behavorial Pain Scale, PAIN Algorithm, Pain Behavior Observation Tool, Critical Care Pain Observation Tool, Nociception Coma Scale, Nonverbal Pain Assessment Tool, Cardiac Analgesic Assessment Scale) directly before and during potentially painful procedures. 8. Difference in measurement precision and duration between different algorithms to estimate the pupillary dilatio

—

Countries

Germany

Contacts

Public ContactStefan Schaller

Charité – Universitätsmedizin Berlin, Klinik für Anästhesiologie m.S. operative Intensivmedizin CCM + CVK, Charitéplatz 1, 10117 Berlin

stefan.schaller@charite.de030 450 531052

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 12, 2026