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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-05-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Daily

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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.

Opioids

Intervention Type DRUG

Standard of care for pain management.

Group 2: Continuous

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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.

Opioids

Intervention Type DRUG

Standard of care for pain management.

Interventions

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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.

Intervention Type DRUG

Opioids

Standard of care for pain management.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No