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Ketamine Patient-Controlled Analgesia for Acute Pain

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Pain; Multiple Trauma; Fractures

Intervention: Ketamine (Drug); Hydromorphone (Drug)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Sheila C Takieddine, Pharm.D., Principal Investigator, Affiliation: UC Health
Eric W Mueller, Pharm.D., Principal Investigator, Affiliation: UC Health


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Total daily opioid requirement

Secondary outcome:

Breakthrough daily opioid requirement

Frequency of change of PCA therapy intensity

Worst pain score

Median pain score

Change in pain score


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Age greater than or equal to 18 years

- Total Injury Severity Score greater than 9

- At least one major orthopedic injury (upper or extremity fracture, abbreviated injury

score great than or equal to 2)

- 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

Locations and Contacts

University of Cincinnati Medical Center, Cincinnati, Ohio 45229, United States
Additional Information

Starting date: April 2014
Last updated: June 18, 2015

Page last updated: August 23, 2015

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