Analgesia-First Sedation in Trauma Patients

NCT05751863 | Recruiting

• 1 other identifier: 279-22
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Keywords

Trauma; Analgesia; Sedation; Intubation

Outcome Measures

Primary Outcomes (1)

• Mechanical Ventilation days until successful extubation

  Duration of mechanical ventilation

  28 days

Secondary Outcomes (1)

• Duration of MV weaning

  28 days

Other Outcomes (2)

• ICU length of stay

  28 days

• Adverse Events related to Mechanical Ventilation

  28 days

Study Arms (2)

Analgesia First Sedation

EXPERIMENTAL

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.

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

Protocol Directed Sedation and Daily Sedation Interruption

ACTIVE COMPARATOR

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.

Other: Protocol Directed Sedation and Daily Sedation Interruption

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.

Analgesia First Sedation

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.

Protocol Directed Sedation and Daily Sedation Interruption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MemorialCare Health System: lead

Study Sites (1)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

RECRUITING

Related Publications (4)

• Mehta S, Burry L, Cook D, Fergusson D, Steinberg M, Granton J, Herridge M, Ferguson N, Devlin J, Tanios M, Dodek P, Fowler R, Burns K, Jacka M, Olafson K, Skrobik Y, Hebert P, Sabri E, Meade M; SLEAP Investigators; Canadian Critical Care Trials Group. Daily sedation interruption in mechanically ventilated critically ill patients cared for with a sedation protocol: a randomized controlled trial. JAMA. 2012 Nov 21;308(19):1985-92. doi: 10.1001/jama.2012.13872.

  PMID: 23180503 BACKGROUND

• Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

  PMID: 30113379 BACKGROUND

• Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.

  PMID: 20116842 BACKGROUND

• Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.

  PMID: 10816184 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Wounds and Injuries; Agnosia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maged Tanios, MD, MPH

  Long Beach Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maged Tanios, MD, MPH

CONTACT

562-424-800; tanios@memorialcare.org

Hyunsoon Park, RN

CONTACT

562-933-7176; hpark@memorialcare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Model Details: We will enroll patients admitted into the MemorialCare Long Beach Medical Center Intensive Care Unit. Only patients admitted to the Trauma service and are mechanically ventilated, requiring continuous intravenous administration of sedatives and/or analgesics, and are anticipated to require MV for will be screened. Each month of the trial, the Trauma patients were assigned to use either protocol-directed sedation (PDS) plus daily sedation interruption (DSI) protocol (even numbered months) or Analgesia First Sedation (AFS) protocol (odd-numbered months). This is a pragmatic, unblinded, cluster-randomized, multiple-crossover study to evaluate the efficacy and safety of AFS versus PDS-DSI.

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 2, 2023
• Study Start: April 1, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)