Intraoperative Low-dose Ketamine Infusion as the Main Analgesic in Burn Patients

NCT03049930 | Unknown Phase 4 FDA Drug

• 1 other identifier: 209459
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

Burns; Ketamine; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Intraoperative fentanyl

  For all participants, the dose of intraoperative fentanyl will be recorded in micrograms and compared between the two arms.

  24 hours

Secondary Outcomes (1)

• Time to the first narcotic

  24 hours

Study Arms (2)

Ketamine

EXPERIMENTAL

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.

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

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

Drug: Sodium chloride

Interventions

Ketamine DRUG

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.

Also known as: Ketalar

Ketamine

Sodium chloride DRUG

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (4)

• Ahern TL, Herring AA, Miller S, Frazee BW. Low-Dose Ketamine Infusion for Emergency Department Patients with Severe Pain. Pain Med. 2015 Jul;16(7):1402-9. doi: 10.1111/pme.12705. Epub 2015 Feb 3.

  PMID: 25643741 BACKGROUND

• Gupta A, Devi LA, Gomes I. Potentiation of mu-opioid receptor-mediated signaling by ketamine. J Neurochem. 2011 Oct;119(2):294-302. doi: 10.1111/j.1471-4159.2011.07361.x. Epub 2011 Sep 20.

  PMID: 21692801 BACKGROUND

• Kaur S, Saroa R, Aggarwal S. Effect of intraoperative infusion of low-dose ketamine on management of postoperative analgesia. J Nat Sci Biol Med. 2015 Jul-Dec;6(2):378-82. doi: 10.4103/0976-9668.160012.

  PMID: 26283834 BACKGROUND

• Mion G, Villevieille T. Ketamine pharmacology: an update (pharmacodynamics and molecular aspects, recent findings). CNS Neurosci Ther. 2013 Jun;19(6):370-80. doi: 10.1111/cns.12099. Epub 2013 Apr 10.

  PMID: 23575437 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Katharine Miles, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharine Miles, MD

CONTACT

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

Jane Wido

CONTACT

708-216-5119

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: No other parties are masked in the clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: The intervention study model is a randomized block design using a 1:1 allocation scheme

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: February 27, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)