Clinical trial NCT02062879: Ketamine Patient-Controlled Analgesia for Acute Pain
Official title: Ketamine Patient-Controlled Analgesia for Acute Pain in Native Airway Multiple and Orthopedic Trauma Patients: A Randomized, Active Comparator, Blinded Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Pain
Multiple Trauma
Fractures
Keywords: pain
trauma
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Daily Opioid Requirement
timeFrame: Participants will be followed for their entire hospital stay, an expected average of 1 week.
Secondary outcomes:
measure: Breakthrough Daily Opioid Requirement
timeFrame: Participants will be followed for their entire hospital stay, an expected average of 1 week
measure: Median Pain Score
timeFrame: Participants will be followed for their entire hospital stay, an expected average of 1 week
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: UC Health
name: Sheila C Takieddine, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Health
name: Eric W Mueller, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Takieddine SC, Droege CA, Ernst N, Droege ME, Webb M, Branson RD, Gerlach TW, Robinson BRH, Johannigman JA, Mueller EW. Ketamine versus hydromorphone patient-controlled analgesia for acute pain in trauma patients. J Surg Res. 2018 May;225:6-14. doi: 10.1016/j.jss.2017.12.019. Epub 2018 Jan 8.