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

NCT ID: NCT04061330

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketamine Group

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

Initial bolus of ketamine 0.3 mg/kg IV (maximum 30 mg) followed by ketamine infusion of 0.25mg/kg/hr (maximum 25mg/kg/hr) for 6 hours or until patient leaves the emergency department (ED),whichever occurs first.

Opioid group

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

Bolus doses of morphine 0.1 mg/kg (maximum 8 mg) intravenously every 2 hours for 6 hours or until patient leaves the ED, whichever occurs first.

Interventions

Ketamine

Initial bolus of ketamine 0.3 mg/kg IV (maximum 30 mg) followed by ketamine infusion of 0.25mg/kg/hr (maximum 25mg/kg/hr) for 6 hours or until patient leaves the emergency department (ED),whichever occurs first.

Intervention Type: DRUG

Morphine

Bolus doses of morphine 0.1 mg/kg (maximum 8 mg) intravenously every 2 hours for 6 hours or until patient leaves the ED, whichever occurs first.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Paulina Sergot

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulina Sergot, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-19-0580

Identifier Type: -

Identifier Source: org_study_id