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NCT Number: NCT05488834

Nurse-led Pain Management in Adult ICU

This project is about implementing a pain scale, the Critical Care Pain Observation Tool (CPOT), in ICU settings at King Abdullah Medical City to evaluate its impact on nurse pain assessment and management.

Pain is considered as a significant problem in ICU and the literature shows that 50% of patients in ICU suffer moderate to severe pain and up to 70% of patients experience undetected pain while in ICU. The CPOT is an evidence-based intervention to assess pain among non-verbal patients in ICU settings. A stepped-Wedge Randomised trial will be used to implement the CPOT in 8 ICU in King Abduullah Medical City. Patient chart audits and a survey of ICU nurses will be conducted post implementation.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz Medical City

Riyadh, Saudi Arabia

About this study

This project is about implementing a pain scale, Critical Care Pain Observation Tool (CPOT), in 8 adult ICUs in King Abdullah Medical City to evaluate the impact on nurse pain assessment and management.

The literature shows that pain is perceived to be one of the most concerning issues in ICU and that 50% of patients in the ICU suffer moderate to severe pain. In addition, 70% of patients have undetected pain while admitted to ICU. Evidence-based guidelines suggest that CPOT is the most reliable and efficient pain scale tool for non-verbal patients in ICUs, and it is recommended in countries such as the USA, Canada, Australia and New Zealand. The literature suggests that CPOT has a positive impact on frequency of pain assessment.

A Stepped-Wedge Randomised trial will be used to implement the CPOT and at the same time assess the effectiveness of CPOT on pain assessment frequency and management. Patient charts will be audited, and a survey of nurses will be undertaken post CPOT implementation to assess the CPOT acceptability, appropriateness and feasibility.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Patient chart audits

Inclusion criteria

  • Patient's who are 18 years and above
  • Patients must be discharged from ICU

Exclusion criteria

  • Patient's who are on muscle relaxants

Nurses survey

Inclusion criteria

  • Working in ICU
  • Understand English language

Treatment and study plan

Critical-Care Pain Observation Tool

Other

The Critical Care Pain Observation Tool (CPOT) was created to help assess pain in critically ill patients who were unable to self-report pain.

The CPOT instrument evaluates facial expression, body movement, muscle tension, and compliance with ventilator or vocalisation to evaluate an individual's pain. The total score ranges from 0 to 8, where 8 is the worst pain. Patients are observed for 60 seconds while resting and during nociceptive procedures such as turning or wound dressings to detect any change in behaviour that could indicate pain. Further, the patient must be observed before and at the peak of analgesia medications administered to evaluate pain treatment effectiveness.

Other names: CPOT

Primary outcomes

  1. Number of documented pain assessments per 24-hour period

    Time frame: 6 months

    How many times pain is documented and reassessed then charted in the medical file for a non-verbal patient over a 24 hour period.

Secondary outcomes

  1. Level of sedation and analgesia

    Time frame: 6 months

    Measurement of the amount of sedation and analgesics administered to patients. For opioids such as Morphine, the Morphine equivalent units (MME) will be used to standardise the level of analgesia given per day. Other opioids will be equalised to Morphine using this formula: MME/day = Dosage X Doses per day X MME conversion Factor (Sinha et al., 2017).

  2. Length of intubation (LOI)

    Time frame: 6 months

    The LOI is the total time a patient was intubated and invasively ventilated.

  3. ICU stay

    Time frame: 6 months

    The ICU stay is the total time in days that the patient was been admitted to the ICU.

  4. Acceptability

    Time frame: 6 months

    To measure the acceptability of the CPOT intervention, the candidate will apply the post-intervention survey and measure how acceptable the CPOT is to nurses working in the ICUs.

  5. Appropriateness

    Time frame: 6 months

    To measure the perceived fit, compatibility or relevance of the CPOT intervention to nurses working in the ICUs using the post-intervention survey.

  6. Feasibility in nursing practice

    Time frame: 6 months

    To measure how feasible it is to implement the CPOT intervention within the ICUs using the post-intervention survey

Sponsors and collaborators

Lead sponsor

King Abdulaziz Medical City

Other Gov

Collaborators

  • Newcastle University
  • Qassim University

Registry information

Official study title

Nurse-led Pain Management in Adult ICU; A Randomised Stepped-Wedge Hybrid Effectiveness Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2022
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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