Ketamine for Acute Pain Management After Trauma

NCT04129086 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: HSC-MS-19-0726
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of Ketamine drip along with usual care and usual care alone on trauma patients and to longitudinally quantify the pain experience of patients during hospitalization.

Conditions

Trauma Injury; Pain; Opioid Use

Keywords

Multimodal Pain Therapy; Ketamine; Trauma

Outcome Measures

Primary Outcomes (1)

• Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day

  In-hospital days (up to 6 weeks post hospital admission)

Secondary Outcomes (33)

• Pain as Assessed by Score on the Numeric Rating Scale (NRS)

  Hospital discharge (up to 6 weeks post hospital admission)

• Number of Patients That Showed Signs of Delirium During In-hospital Stay

  Hospital discharge (up to 6 weeks post hospital admission)

• Number of Patients That Required Unplanned Intubation During In-hospital Stay

  Hospital discharge (up to 6 weeks post hospital admission)

• Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay

  Hospital discharge (up to 6 weeks post hospital admission)

• Initiation of Ketamine Drip

  Hospital discharge (up to 6 weeks post hospital admission)

Study Arms (2)

Ketamine plus Usual care

EXPERIMENTAL

Drug: Ketamine plus usual care

Usual care

ACTIVE COMPARATOR

Drug: Usual Care

Interventions

Ketamine plus usual care DRUG

Bolus of .35 mg/kg Infusion start @ 0.15 mg/kg/hr; titrate range is 0.1 - 0.25 mg/kg/hr for 24 to 48 hours after admission and each subsequent major surgery plus multi-modal pain therapy considered as standard of care. Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.

Ketamine plus Usual care

Usual Care DRUG

Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.

Usual care

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult trauma patients
• Admission to Shock Trauma ICU (STICU) or Surgical Intermediate Unit (SIMU)
• Randomization within 6 hours of arrival

You may not qualify if:

• Patient not expected to survive
• Contraindications to ketamine Allergy, Poorly controlled hypertension, Cardiac arrhythmia disorders (including atrial fibrillation), congestive heart failure, unstable coronary artery disease or recent myocardial infarction( MI)(within 6 months), cirrhosis, seizure disorder, and for those patients with unknown medical history - median sternotomy scar, mechanism of injury is fall from standing, 65 years of age or older, any arrhythmia on EKD)
• pregnancy
• in police custody
• history of dementia or movement disorder (i.e. Parkinson's)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Klugh JM, Puzio TJ, Wandling MW, Guy-Frank CJ, Green C, Sergot PB, Prater SJ, Balogh J, Stephens CT, Wade CE, Kao LS, Harvin JA. Ketamine for acute pain after trauma: A pragmatic, randomized clinical trial. J Trauma Acute Care Surg. 2024 Oct 1;97(4):514-519. doi: 10.1097/TA.0000000000004325. Epub 2024 May 1.

  PMID: 38689402 DERIVED

• Puzio TJ, Klugh J, Wandling MW, Green C, Balogh J, Prater SJ, Stephens CT, Sergot PB, Wade CE, Kao LS, Harvin JA. Ketamine for acute pain after trauma: the KAPT randomized controlled trial. Trials. 2022 Jul 27;23(1):599. doi: 10.1186/s13063-022-06511-6.

  PMID: 35897081 DERIVED

MeSH Terms

Conditions

Accidental Injuries; Pain; Wounds and Injuries

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: John Andrew Harvin, MD
• Organization: The University of Texas Health Science Center at Houston

John.Harvin@uth.tmc.edu

713-500-7292

Study Officials

• John P Harvin, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 16, 2019
• Study Start: July 1, 2020
• Primary Completion: March 30, 2022
• Study Completion: September 30, 2022
• Last Updated: April 21, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)