Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial.
Sangeeta Mehta, Lisa Burry, Deborah Cook...
https://pubmed.ncbi.nlm.nih.gov/23180503/Actively Recruiting
Led by MemorialCare Health System · Updated on 2025-07-09
170
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are evaluating the best sedation and pain management approach for trauma patients needing mechanical ventilation. The study compares continuous sedative and pain medication infusions with an analgesia-first strategy, where sedatives are reserved for brief use as needed. Although sedation protocols have improved outcomes in medical ICU patients, it remains unclear which method is better for surgical trauma patients. Participants will be randomly assigned to receive either analgesia-first sedation using intermittent fentanyl doses with sedatives added only if necessary, or protocol-directed sedation with continuous infusions of analgesics and sedatives interrupted daily. Both groups will be managed with approved ICU protocols, with daily assessments for ventilator weaning. During the study, participants will be monitored for days on mechanical ventilation until successful extubation, as well as duration of weaning. Researchers will track ICU and hospital length of stay, sedation levels, pain control, and safety outcomes. The total participation time includes at least 28 days of outcome measurement, with regular assessments to guide sedation and ventilation management.
CONDITIONS
Analgesia-First Sedation in Trauma Patients
M
Maged Tanios, MD, MPH
H
Hyunsoon Park, RN
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MemorialCare Health System
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Analgesia-First Sedation | Protocol-Directed Sedation with Daily Interruption |
|---|---|---|
| What it is | An 'analgesia-first' strategy for sedation in mechanically ventilated trauma patients, where pain is primarily managed with intermittent analgesic boluses and an IV drip is added only as needed. Sedatives are used strictly for agitation and only for short periods. | A protocol-driven approach where sedative and analgesic IV infusions are given together and both are stopped every day to assess whether patients can be woken and potentially weaned from the ventilator. |
| Role in trial | Investigational intervention tested to determine if prioritizing pain management before sedative use improves outcomes during mechanical ventilation. | Active comparator arm, using a commonly established sedation protocol in ICU care. |
| Primary use | To manage pain and minimize sedative exposure in mechanically ventilated trauma patients. | Combined use of sedatives and analgesics to maintain comfort and allow daily assessment for possible weaning. |
| How it is given or performed | Analgesics are administered as intermittent boluses first, with an IV infusion started only if necessary; sedatives are reserved for agitation and short-term use. | IV infusions of both sedatives and analgesics are used together, and both are paused each day for at least one assessment of arousability and readiness for ventilator weaning. |
| Evidence status | Large trials and guidelines in critically ill adults support the use of analgesia-first ('analgosedation') strategies in the ICU as a preferred approach for minimizing sedative exposure. | A well-established sedation protocol involving daily interruption has shown safety, feasibility, and a reduction in ventilator duration in previous randomized controlled trials. |
| Important limitations | Real-world effectiveness may depend on protocol adherence, staff training, and the ability to identify and manage pain accurately. Published evidence is mostly from mixed ICU populations, with fewer trauma-specific trials. | Patients may still experience excessive sedation, and agitation can occur during daily interruption; outcomes depend on consistent application and patient selection. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive one of two sedation strategies to facilitate mechanical ventilation: either intermittent analgesic boluses followed by sedative infusions as needed (Analgesia First Sedation), or continuous intravenous infusions of analgesics and sedatives with daily interruption (Protocol Directed Sedation and Daily Sedation Interruption). Participants are assessed daily for ventilator weaning readiness.
Daily assessments during mechanical ventilation
Duration - Up to 28 days
After cessation of sedation treatment, participants are monitored for mechanical ventilation outcomes and ICU/hospital length of stay.
Visits as needed during ICU stay
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Sangeeta Mehta, Lisa Burry, Deborah Cook...
https://pubmed.ncbi.nlm.nih.gov/23180503/Thomas Strøm, Torben Martinussen, Palle Toft
https://pubmed.ncbi.nlm.nih.gov/20116842/J P Kress, A S Pohlman, M F O'Connor...
https://pubmed.ncbi.nlm.nih.gov/10816184/Maged A Tanios, Huan Mark Nguyen, Jeffry Nahmias...
https://pubmed.ncbi.nlm.nih.gov/41717531/John W Devlin, Yoanna Skrobik, Céline Gélinas...
https://pubmed.ncbi.nlm.nih.gov/30113379/MemorialCare Health System
Lead Sponsor