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

NCT03095222 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: STUDY00004424
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 4

Secondary Outcomes (2)

• Opioid Analgesic Consumption

  Day 4

• Side effects / Adverse effects

  Days 1-4

Study Arms (2)

Group 1: Daily

ACTIVE COMPARATOR

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

Drug: Ketamine; Drug: Opioids

Group 2: Continuous

ACTIVE COMPARATOR

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

Drug: Ketamine; Drug: Opioids

Interventions

Ketamine 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.

Group 1: Daily; Group 2: Continuous

Opioids DRUG

Standard of care for pain management.

Group 1: Daily; Group 2: Continuous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ketamine; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Andrea Nicol, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: March 29, 2017
• Study Start: April 1, 2017
• Primary Completion: May 24, 2018
• Study Completion: May 24, 2018
• Last Updated: October 31, 2018

Record last verified: 2017-05

Locations

US (1)