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

Primary Purpose

Pain

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Opioids
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1: Daily

Group 2: Continuous

Arm Description

Daily ketamine infusions of 5 hours in length. Duration of participation will last 4 days.

Continuous ketamine infusions (24 hours/day). Duration of participation will last 4 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Side effects / Adverse effects
Any side effects or adverse effects attributed to ketamine infusions will be recorded.

Full Information

First Posted
March 23, 2017
Last Updated
October 29, 2018
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03095222
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The study never screened or enrolled any subjects due to stalled recruitment efforts.
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Daily
Arm Type
Active Comparator
Arm Description
Daily ketamine infusions of 5 hours in length. Duration of participation will last 4 days.
Arm Title
Group 2: Continuous
Arm Type
Active Comparator
Arm Description
Continuous ketamine infusions (24 hours/day). Duration of participation will last 4 days.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Opioids
Intervention Description
Standard of care for pain management.
Primary Outcome Measure Information:
Title
Change in pain severity
Description
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.
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Opioid Analgesic Consumption
Description
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.
Time Frame
Day 4
Title
Side effects / Adverse effects
Description
Any side effects or adverse effects attributed to ketamine infusions will be recorded.
Time Frame
Days 1-4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Nicol, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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