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

University of Kansas

Status and phase: Withdrawn; Phase 4

Conditions: Pain

Treatments: Drug: Opioids; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03095222

STUDY00004424

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group 1: Daily

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Drug: Opioids

Group 2: Continuous

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Drug: Opioids