Assessment of Chronic Pain in Survivors of Intensive Care

Pain After Survival From the Intensive Care Unit (PAIN-ICU): A Prospective, Multicentre, Observational Cohort Study to Determine the Incidence, Risk Factors and Impact of Chronic Pain in Critically Ill Adult Patients Discharged from ICU.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619000637145

Acronym

PAIN-ICU

Enrollment

300

Registered

2019-04-30

Start date

2019-10-01

Completion date

2020-10-01

Last updated

2019-07-15

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

Conditions

None listed

Brief summary

Improvements in the management of critically ill patients have resulted in improved survival. However, these survivors are at an increased risk of cognitive, psychiatric and physical disability. This constellation of symptoms is known as Post-ICU Syndrome (PICS). One particular component of PICS is the development of chronic pain. Clinically and epidemiologically, chronic pain has been defined as pain that persists for 3 months or more Currently, the incidence of chronic pain in survivors of intensive care in Australia is unknown. The current literature from overseas estimates the incidence of chronic pain to be between 40-60% of ICU survivors. To date, there are no studies that have identified modifiable risk factors that therapeutic interventions can target to prevent the development of chronic pain. In addition, there is no literature about long-term opioid use in survivors of ICU. Hence, noting that there is a high incidence of chronic pain in ICU survivors, we aim to confirm this and hypothesise that risk factors associated with analgesic management, sedative management and immobility are implicated in the development of chronic pain. We plan to do this by conducting a large cohort study that accurately measures chronic pain using internationally recommended definitions. In addition, we will evaluate the impact of chronic pain (i.e. requirement of opioids, quality of life, interference, neuropathic components, psychiatric comorbidities, employment) using validated scales. We will also identify modifiable risk factors to develop targeted therapeutic interventions that aim to reduce the incidence of chronic pain, which will inform larger therapeutic clinical trials.

Interventions

The outcome of chronic pain will be determined by a 30-minute phone interview 6 months after ICU discharge. A questionnaire will determine the incidence and characteristics of Chronic Post-ICU Pain (CPIP) and the impact of chronic pain (post-traumatic stress disorder, prolonged opioid use, anxiety, depression, productivity). Data collected during the ICU admission will determine modifiable risk factors for the development of chronic pain.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients admitted to the intensive care unit that have survived to ICU discharge. 2. Age > 18 years.

Exclusion criteria

1. Known diagnosis of chronic pain. 2. Death is deemed inevitable or imminent during this admission and either the attending physician, patient or surrogate legal decision maker is not committed to active treatment. 3. Known diagnosis of mild to severe cognitive impairment. 4. Proven or suspected primary neurological lesion including traumatic brain injury (TBI), subarachnoid haemorrhage (SAH), intracerebral haemorrhage (ICH), cerebrovascular accident (CVA), hypoxic ischaemic encephalopathy (HIE). 5. Inability to communicate in English. 6. The patient has been previously enrolled in the trial.

Outcome results