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

Phase 4

Withdrawn

• Conditions: Pain
• Interventions: Drug: Ketamine; Drug: Opioids

• Registration Number: NCT03095222
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Study Start: 2017-04-01
• Status Verified: 2017-05
• Primary Completion: 2018-05-24
• Study Completion: 2018-05-24
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Daily	Opioids	Daily ketamine infusions of 5 hours in length. Duration of participation will last 4 days.
Group 2: Continuous	Opioids	Continuous ketamine infusions (24 hours/day). Duration of participation will last 4 days.
Group 1: Daily	Ketamine	Daily ketamine infusions of 5 hours in length. Duration of participation will last 4 days.
Group 2: Continuous	Ketamine	Continuous ketamine infusions (24 hours/day). Duration of participation will last 4 days.

Primary Outcome Measures

Name	Time	Method
Change in pain severity	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

Name	Time	Method
Opioid Analgesic Consumption	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	Days 1-4	Any side effects or adverse effects attributed to ketamine infusions will be recorded.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States