Recruiting

Analgesia-First

Sponsor:

MemorialCare Health System

Code:

NCT05751863

Conditions

Mechanical Ventilation

Respiratory Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Analgesia First Sedation Strategy for Mechanically Ventilated (MV) Trauma Subjects

Protocol Directed Sedation and Daily Sedation Interruption

Study Details

Brief summary:

The study's aim is to ascertain the best approach for providing sedation and pain management for patients who have sustained trauma and are requiring respiratory support from a mechanical ventilator. The common approach to patients who need mechanical ventilation is to provide continuous drips of sedatives and pain medicine and awaken the patient once a day to check the brain functions. Another approach is to provide pain medicine and reserve sedatives for only a short duration when needed. The difference between approaches has not been studied in Trauma patients.

Conditions

Mechanical Ventilation

Respiratory Failure

Study ID

NCT05751863

Start date

Apr 1, 2023

Status verified date

Jul, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥ 18 years of age
2. Mechanically ventilated with an expected duration of MV ≥ 48h
3. Initiated continuous sedative/analgesic infusions by the ICU team
4. Patient is a candidate for MV weaning

Exclusion Criteria:

1. Admission after resuscitation from cardiac arrest
2. Significant neurological deficit due to a chronic disorder
3. History of alcohol dependence and/or other illicit drug abuse
4. Prior administration of continuous sedative/analgesic from a transferring institution
5. Patient receiving neuromuscular blocking agents
6. Allergy to midazolam, lorazepam, and/or propofol

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Analgesia First Sedation

Subjects will be randomized to receive analgesia-first sedation by intermittent doses of Fentanyl (25 mcg), instead of continuous IV infusions. If the intermittent IVP x4 fails to achieve the target pain score, an infusion starts at 50 mcg/hr and titration by 25 mcg q15 minutes. If sedation score is not achieved, propofol infusion starts at 5 mcg/kg/min to achieve goal RASS of 0 to -2. Subjects will be assessed for a ventilator weaning trial daily.

active comparator: Protocol Directed Sedation and Daily Sedation Interruption

Pain management will be initiated with intravenous fentanyl at 50 mcg/hr. If the goal pain score is not achieved, use bolus doses and increase the rate by 25 mcg/hr every 15 minutes until the goal pain score is achieved. If the goal pain score is surpassed, lower the rate by 25 mcg/hr every 15 minutes. If at goal pain score, continue the current dose. If RASS scores less than the goal and Propofol is already off - decrease Fentanyl infusion.

Agitation management will be initiated with intravenous propofol starting at 5 mcg/kg/min. Bolus doses will be used, and the rate will be increased by 5 mcg/kg/min every 15 minutes until goal RASS is achieved. If goal RASS is surpassed, lower the rate by 5 mcg/kg/min every 15 minutes until goal RASS is achieved. Bolus dose: 25 mg IVP every 5 minutes up to 2 doses PRN agitation before increasing infusion rate. Midazolam or dexmedetomidine substitutions for propofol are allowed according to the institutional protocol.

Interventions

Analgesia First Sedation Strategy for Mechanically Ventilated (MV) Trauma Subjects

The Intervention is using a sedation strategy for MV trauma that initially targets pain by intermittent boluses followed by an IV drip only if required. Sedatives are limited to agitation management and for a limited duration as needed. This "analgo-sedation" approach differs from the approach of using IV drips of analgesics and sedatives simultaneously and discontinuing both once daily to assess subjects.

Protocol Directed Sedation and Daily Sedation Interruption

The active comparator in this study is using a sedation strategy for MV trauma that uses IV drips of analgesics and sedatives simultaneously and discontinues both once daily to assess subjects.

Primary outcome measure

  • Mechanical Ventilation days until successful extubation [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Maged Tanios, MD, MPH

562-424-800tanios@memorialcare.org

Hyunsoon Park, RN

562-933-7176hpark@memorialcare.org

Locations

Long Beach Memorial Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Hyunsoon Park, RN

562-933-7176hpark@memorialcare.org

Principal Investigator:

Maged Tanios, MD. MPH

More Information

Sponsor

MemorialCare Health System

Last update posted

Jul 9, 2025

Last verified

Jul, 2025

Keywords

  • Trauma
  • Analgesia
  • Sedation
  • Intubation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MemorialCare Health System on 2025-07-09.