Recruiting

Ketamine

Sponsor:

Loyola University

Code:

NCT03049930

Conditions

Burns

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ketamine

Sodium chloride

Study Details

Brief summary:

The purpose of this study is to determine whether a low-dose ketamine infusion can be used as the main intra-operative analgesic in different burn patients, and thereby reduce the total intra-operative opioid requirement. Secondary objectives are to determine whether this low-dose ketamine infusion will lengthen the amount of time to the first narcotic given in the recovery room or ICU, and whether pain scores for awake patients will be lower post-operatively.

Conditions

Burns

Study ID

NCT03049930

Start date

Feb 27, 2018

Status verified date

Mar, 2019

Completion date

Aug, 2020

Anticipated

Primary completion date

Aug, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All adult burn patients aged 18-80 presenting to the operating room, both intubated and non-intubated
  • Patients having a procedure performed in Russo operating rooms at Loyola University Medical Center

Exclusion Criteria:

  • Allergy to ketamine or benzodiazepines
  • Ketamine use in the preceding 24 hours
  • Children (patients under age 18), prisoners, pregnant or breastfeeding women, patients with psychosis, patients with developmental delay, and any condition which, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of the trial endpoints.
  • Increased intracranial pressure at the discretion of the investigator
  • Increased intraocular pressure at the discretion of the investigator
  • Porphyria at the discretion of the investigator
  • Thyroid disorders at the discretion of the investigator

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine

Participants randomized to this arm will receive ketamine (1 mg/ml solution) infused at 0.2 mg/kg/hour (0.2 ml/kg/h) for a maximum of 20 ml/hour.

placebo comparator: Placebo

Participants randomized to this arm will receive 0.9 mg/ml sodium chloride, infused at a rate of 0.2 ml/kg/hour

Interventions

Ketamine

Ketamine is a medication used for starting and maintaining anesthesia. Participants randomized to the ketamine arm will receive 1 mg/ml solution infused at 0.2 mg/kg/hour (0.2 ml/kg/h) for a maximum of 20 ml/hour.

Sodium chloride

Participants randomized to the placebo arm will receive 0.9 mg/ml sodium chloride, infused at a rate of 0.2 ml/kg/hour

Primary outcome measure

  • Intraoperative fentanyl [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Katharine Miles, MD

708-216-4174katharine.miles@lumc.edu

Jane Wido

708-216-5119

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Katharine Miles, MD

708-216-4174katharine.miles@lumc.edu

Jane Wido

708-216-5119jwido@lumc.edu

More Information

Sponsor

Loyola University

Last update posted

Mar 14, 2019

Last verified

Mar, 2019

Keywords

  • Burns
  • Ketamine
  • Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2019-03-14.