Ketamine for Acute Pain Management After Trauma (KAPT)

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Trauma Injury; Opioid Use; Pain

Treatments: Drug: Usual Care; Drug: Ketamine plus usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04129086

HSC-MS-19-0726

Details and patient eligibility

About

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.

Enrollment: 305 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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305 participants in 2 patient groups

Ketamine plus Usual care

Experimental group

Treatment:

Drug: Ketamine plus usual care

Usual care

Active Comparator group

Treatment:

Drug: Usual Care