Ketamine Patient-Controlled Analgesia for Acute Pain

Study Overview
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Brief Summary
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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.

Official Title
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Ketamine Patient-Controlled Analgesia for Acute Pain in Native Airway Multiple and Orthopedic Trauma Patients: A Randomized, Active Comparator, Blinded Trial

Conditions
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Acute Pain, Multiple Trauma, Fractures

Intervention / Treatment
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* Drug: Ketamine
* Drug: Hydromorphone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine<br>Ketamine 90mg/30 mL PCA (3 mg/mL) | Drug: Ketamine<br>* Ketamine administered as patient-controlled analgesia.<br>* Other names: Ketalar;|
| Active Comparator: Hydromorphone<br>Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) | Drug: Hydromorphone<br>* Hydromorphone administered as patient-controlled analgesia.<br>* Other names: Dilaudid;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma, pain