Ketamine Patient-Controlled Analgesia for Acute Pain

University of Cincinnati

Status and phase: Terminated; Phase 3

Conditions: Multiple Trauma; Fractures; Acute Pain

Treatments: Drug: Hydromorphone; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02062879

Mueller2014

Details and patient eligibility

About

This study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. Patients receiving ketamine PCA are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. Patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. Ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than or equal to 18 years
• Total Injury Severity Score greater than 9
• Functioning intravenous catheter present per standard of care
• Patient planned to receive PCA for acute pain per standard of care
• Patient ability to effectively use a PCA device as assessed by the primary attending trauma service
• Negative pregnancy test for women of childbearing age

Exclusion criteria

• Body mass index greater than 35
• History of active psychiatric disease
• Acute or chronic liver or renal failure
• History of heart failure or coronary artery disease
• Patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy
• Patients who abuse alcohol and are at high risk for alcohol withdrawal
• Intubated patients
• Glasgow Coma Scale score less than 13, or motor subscore less than 6
• Documented allergy to ketamine, hydromorphone, or lorazepam
• Pregnancy
• Incarceration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Ketamine

Experimental group

Description:

Ketamine 90mg/30 mL PCA (3 mg/mL)

Treatment:

Drug: Ketamine

Hydromorphone

Active Comparator group

Description:

Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)

Treatment:

Drug: Hydromorphone