Analgesia-First Sedation in Trauma Patients

Part of paid clinical trials in Long Beach, California.

Sponsor
MemorialCare Health System
Study ID
NCT05751863
Status
Recruiting
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Conditions

  • Mechanical Ventilation
  • Respiratory Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Analgesia First Sedation Strategy for Mechanically Ventilated (MV) Trauma Subjects — OTHER
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2023
Status verified
Jul 2025
Primary completion
Mar 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Long Beach Memorial Medical CenterLong BeachCalifornia90806
Hyunsoon Park, RN
[email protected]
562-933-7176
Maged Tanios, MD. MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Long Beach Memorial Medical Center· Long Beach, CA

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