Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 2

Conditions: Pain, Acute

Treatments: Drug: Ketamine; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT04061330

HSC-MS-19-0580

Details and patient eligibility

About

The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of patient stay in the emergency department.

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients presenting to the ED with long bone fracture, open or closed.Long bone fractures include:humerus, radius, ulna, femur, tibia, fibula.

Exclusion criteria

• Received morphine in the ED prior to enrollment
• Received ketamine any time prior to enrollment
• Glasgow Coma Scale(GCS) less than 15
• Transferred from other facility
• Other moderate to severe trauma injuries
• Contraindication to ketamine
• Cannot consent (no intubation, airway issues, hemodynamic instability)
• Prisoners
• Suspected and/or confirmed pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Ketamine Group

Experimental group

Treatment:

Drug: Ketamine

Opioid group

Active Comparator group

Treatment:

Drug: Morphine