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Exploring the Safety and Efficacy of Low-dose Ketamine Infusions for Pain Control in Acute Burn Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03095222
Recruitment Status : Withdrawn (The study never screened or enrolled any subjects due to stalled recruitment efforts.)
First Posted : March 29, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE March 23, 2017
First Posted Date  ICMJE March 29, 2017
Last Update Posted Date October 31, 2018
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date May 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
Change in pain severity [ Time Frame: Day 4 ]
Pain severity measured using the 11-point Visual Numerical Scale (VNS). Scores range from 0 to 10. A score of 0 represents no pain. A score of 10 represents the worst pain imaginable. The score will be collected each day. An average of the score will be calculated for all days of the study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
  • Opioid Analgesic Consumption [ Time Frame: Day 4 ]
    All subjects will be on some form of opioid analgesic. All opioid usage will be recorded. For each 24 hour period, the total daily opioid consumption will be calculated and converted to oral morphine equivalents. The outcome will be reported as an average over all days of participation.
  • Side effects / Adverse effects [ Time Frame: Days 1-4 ]
    Any side effects or adverse effects attributed to ketamine infusions will be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploring the Safety and Efficacy of Low-dose Ketamine Infusions for Pain Control in Acute Burn Injury
Official Title  ICMJE Exploring the Safety and Efficacy of Low-dose Ketamine Infusions for Pain Control in Acute Burn Injury
Brief Summary The purpose of this study is to identify the optimal dosing strategy for low-dose ketamine infusions in adult acute burn injury patients when used with usual pain medications.
Detailed Description This Aim will identify the safest and most optimal dosing strategy for low-dose ketamine infusions. While the hourly rate for low-dose ketamine infusions used for adjunctive analgesia appears to be well-established both in the medical literature and our institutional protocols, there is no information available for this specific population of patients (adult acute burn injury) to know whether the infusions should be utilized for discrete periods of time or should be given continuously. Findings from this study will help provide preliminary data on the optimal dosing strategy of this medication for adjunctive analgesia in this population.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Ketamine
    To be given as intravenous infusion. Ketamine infusions will be started at 5 mg/hr and can be increased by nursing staff based on patient-reported pain relief up to a maximum hourly rate of 20 mg/hr.
  • Drug: Opioids
    Standard of care for pain management.
Study Arms  ICMJE
  • Active Comparator: Group 1: Daily
    Daily ketamine infusions of 5 hours in length. Duration of participation will last 4 days.
    Interventions:
    • Drug: Ketamine
    • Drug: Opioids
  • Active Comparator: Group 2: Continuous
    Continuous ketamine infusions (24 hours/day). Duration of participation will last 4 days.
    Interventions:
    • Drug: Ketamine
    • Drug: Opioids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 29, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2017)
20
Actual Study Completion Date  ICMJE May 24, 2018
Actual Primary Completion Date May 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute burn injury comprising 10-30% of total body surface. Burns severity may include second or third degree burns
  • Burn injury must have occurred within 72 hours of enrollment and randomization
  • Subjects may be opioid-naïve or opioid non-naïve
  • Anticipated stay in the burn unit is greater than 4 days, which is typically the minimum length of stay for patients with this level of burn injury

Exclusion Criteria:

  • Burn injury older than 72 hours
  • Acute burn injury comprising >30% total body surface
  • Patients who are intubated
  • Patients who have contraindication to ketamine administration
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03095222
Other Study ID Numbers  ICMJE STUDY00004424
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Kansas Medical Center
Study Sponsor  ICMJE University of Kansas Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea Nicol, MD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP