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

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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Recruitment Status : Withdrawn (The study never screened or enrolled any subjects due to stalled recruitment efforts.)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

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Ketamine Drug: Opioids Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring the Safety and Efficacy of Low-dose Ketamine Infusions for Pain Control in Acute Burn Injury
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : May 24, 2018
Actual Study Completion Date : May 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
Drug Information available for: Ketamine

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Side effects / Adverse effects [ Time Frame: Days 1-4 ]
    Any side effects or adverse effects attributed to ketamine infusions will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095222


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Andrea Nicol, MD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03095222     History of Changes
Other Study ID Numbers: STUDY00004424
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: May 2017

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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

Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action