Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients
Condition: Wounds and Injuries; Rib Fractures
MeSH terms: Acute Pain; Fractures, Bone; Rib Fractures; Wounds and Injuries
Intervention: Ketamine; Placebo; Intercostal Nerve Block; Acetaminophen; Ibuprofen; Pantoprazole; Methocarbamol; Opioid
Intervention description: All individuals randomized to the experimental arm of the trial will receive early ketamine therapy (within 6 hours of admission) at a rate of 0.15 mg/kg/hr dosed based on ideal body weight. Individuals in the control arm will receive our standard of care for thoracic trauma patients, however, they will receive an additional placebo infusion of normal saline.; Individuals enrolled into the control arm of the trial will receive a normal saline placebo infusion at a rate equivalent to the dosage of ketamine in the experimental arm.; All individuals enrolled into the trial will undergo an Intercostal Nerve Blockade as a part of the institutional standard of care for rib fractures. This procedure will be performed according to current standard protocols in the Emergency Department or on admission.; All patients admitted to the hospital will be placed on scheduled acetaminophen 1000mg PO q 6 hours unless signs of liver disease/impairment or creatinine clearance < 35ml/min at which point dosage would be reduced to 650mg q 8 hours. Individuals unable to take oral medications would be placed on intravenous acetaminophen.; All patients will be placed on scheduled Ibuprofen or an equivalent NSAID at dosage of 600mg every 6 hours. Patients must have a Glomerular Filtration Rate > 60 ml/min with no contraindications to NSAID therapy (e.g. Aspirin use, allergy/sensitivity, concurrent ACE inhibitor use, other nephrotoxins, etc); All individuals on scheduled Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy will receive scheduled pantoprazole at 40mg daily. Individuals unable to take medications orally will be placed on intravenous therapy. Individuals with previous reaction or intolerance to pantoprazole will be placed on an equivalent proton pump inhibitor.; All individuals enrolled in the trial will be placed on scheduled methocarbamol 500 mg orally every 6 hours while admitted. Individuals with previous intolerance to methocarbamol will be placed on a pharmacy directed equivalent.; All individuals will receive as needed opiate therapy as an adjunct to the scheduled medications and "ketamine/placebo" solution. Choice in opiate therapy will be at the discretion of the attending trauma faculty. Dosage and adjustments will be in accordance with the institutional policy on appropriate opiate dosage adjustment.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Ketamine; Narcotics; Methocarbamol; Pantoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effectiveness of ketamine infusions in the management of acute
      pain resulting from broken ribs suffered following a blunt trauma. Half of patients will
      receive the institutional standard of care and a placebo infusion (no active medication). The
      other half of patients will receive the institutional standard of care and a ketamine
      infusion. All subjects and staff will be blinded as to whether they are receiving placebo or
      ketamine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age greater than 18 years

          2. rib fractures following recent trauma with admission to Froedtert Memorial Lutheran
             Hospital

        Exclusion Criteria:

          1. history of adverse reaction / intolerance to ketamine therapy

          2. elevated intracranial pressure

          3. ischemic heart disease defined as active acute coronary syndrome

          4. severe, poorly controlled hypertension (Systolic Blood Pressure > 200 mmHg or
             Diastolic Blood Pressure > 100 mmHg)

          5. current opiate agonist/antagonist therapy

          6. concurrent use of monoamine oxidase inhibitors (MAOIs)

          7. chronic pain or opioid tolerance defined as > 3 weeks of >30mg oral morphine
             equivalents per day

          8. current substance abuse with opiates (prescription and/or heroin) or ketamine

          9. Glasgow Coma Scale <13

         10. Intubation on arrival or need for urgent intubation on arrival

         11. inability to delineate pain and/or appropriately communicate with staff

         12. history of psychosis

         13. three or more psychotropic medications

         14. active delirium

         15. glaucoma

         16. pregnancy

         17. prisoners