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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Drug: Ketamine; Drug: Opioids

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
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Daily; Daily ketamine infusions of 5 hours in length. Duration of participation will last 4 days.	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.
Active Comparator: Group 2: Continuous; Continuous ketamine infusions (24 hours/day). Duration of participation will last 4 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain severity	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.	Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Analgesic Consumption	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.	Day 4
Side effects / Adverse effects	Any side effects or adverse effects attributed to ketamine infusions will be recorded.	Days 1-4

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): May 24, 2018
• Study Completion (Actual): May 24, 2018

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; 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; Ketamine
• Other Study ID Numbers: STUDY00004424

Drug and device information, study documents

• 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