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
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.
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 requirementFrequency of change of PCA therapy intensity Worst pain score Median pain score Change in pain score
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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