Recruiting

Ketamine

Sponsor:

University of Tennessee

Code:

NCT06506565

Conditions

Burn

Pain

Dissociation

Opioid

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketamine

0.9% NaCl

Study Details

Brief summary:

The current standard of care (SOC) (i.e. fentanyl and midazolam) offers limited efficacy for preventing or relieving pain. Ketamine infusions may provide the benefits of analgesia, minimize adverse events, and reduce opioid use. The purpose of this study is to determine if adding a low dose ketamine infusion during wound care will safely provide pain relief for patients with burn injury.

Conditions

Burn

Pain

Dissociation

Opioid

Study ID

NCT06506565

Start date

Jul 8, 2024

Status verified date

Dec, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Admitted to burn service with thermal injury

Exclusion Criteria:

  • unable/unwilling to consent within 72 hours
  • unable to report NRS
  • known contraindication to ketamine
  • < than 18 years of age
  • pregnant
  • incarcerated
  • TBSA over 50 %

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine

Ketamine infusion (0.3 mg/kg/hr) to begin 1 hour before wound care, continuing through and for 1 hour following wound care.

placebo comparator: Placebo

0.9% saline to begin 1 hour before wound care, continuing through and for 1 hour following wound care.

Interventions

Ketamine

Infusion during wound care

0.9% NaCl

Infusion during wound care

Primary outcome measure

  • Analgesia [ Time Frame: up to 7 days from enrollment ]

Central Contacts and Locations

Central contacts

David M Hill, Pharm.D.

1-901-545-7100dhill19@uthsc.edu

Locations

Regional One Health

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Yvonne Shaw, RN

901-448-2714yshaw@uthsc.edu

More Information

Sponsor

University of Tennessee

Last update posted

Dec 13, 2024

Last verified

Dec, 2024

Keywords

  • ketamine
  • burn
  • opioid
  • analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2024-12-13.