Ketamine for Acute Pain Management After Trauma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Trauma Injury Pain Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ketamine plus Usual care

Group Type EXPERIMENTAL

Ketamine plus usual care

Intervention Type 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.

Usual care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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Ketamine plus usual care

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.

Intervention Type DRUG

Usual 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No