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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03095222
• Other study ID #: STUDY00004424
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: May 24, 2018

Study information

• Verified date: May 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 24, 2018
• Est. primary completion date: May 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Pain

Intervention

Drug:
• 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.
• Opioids
Standard of care for pain management.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 4
Secondary	Side effects / Adverse effects	Any side effects or adverse effects attributed to ketamine infusions will be recorded.	Days 1-4