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

• ClinicalTrials.gov Identifier: NCT03095222
• Recruitment Status: Withdrawn
• First Posted: March 29, 2017
• Last Update Posted: October 31, 2018
• Sponsor: University of Kansas Medical Center
• Information provided by (Responsible Party): University of Kansas Medical Center

Tracking Information

• First Submitted Date: March 23, 2017
• First Posted Date: March 29, 2017
• Last Update Posted Date: October 31, 2018
• Actual Study Start Date: April 1, 2017
• Actual Primary Completion Date: May 24, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Exploring the Safety and Efficacy of Low-dose Ketamine Infusions for Pain Control in Acute Burn Injury
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pain

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: October 29, 2018): 0
• Original Estimated Enrollment (submitted: March 23, 2017): 20
• Actual Study Completion Date: May 24, 2018
• Actual Primary Completion Date: May 24, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03095222
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: University of Kansas Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Kansas Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Andrea Nicol, MD; University of Kansas Medical Center

• PRS Account: University of Kansas Medical Center
• Verification Date: May 2017