Ketamine Patient-Controlled Analgesia for Acute Pain

Phase 3

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	Ketamine 90mg/30 mL PCA (3 mg/mL)
Hydromorphone	Hydromorphone	Hydromorphone 6mg/30 mL PCA (0.2 mg/mL)

Primary Outcome Measures

Name	Time	Method
Total Daily Opioid Requirement	Participants will be followed for their entire hospital stay, an expected average of 1 week.	Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Breakthrough Daily Opioid Requirement	Participants will be followed for their entire hospital stay, an expected average of 1 week	Breakthrough daily opioid requirement in milligrams of morphine equivalents/day
Median Pain Score	Participants will be followed for their entire hospital stay, an expected average of 1 week	Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.