Ketamine Patient-Controlled Analgesia for Acute Pain

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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Pain; Multiple Trauma; Fractures
• Intervention / Treatment: Drug: Ketamine; Drug: Hydromorphone

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Sheila C Takieddine, Pharm.D., UC Health; Principal Investigator: Eric W Mueller, Pharm.D., UC Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Actual): September 21, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: trauma; pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Acute Pain; Multiple Trauma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Ketamine; Hydromorphone
• Other Study ID Numbers: Mueller2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No