ClinicalTrials.gg
RecruitingNCT06506565IMPROVEUpdated Dec 13, 2024

Low-Dose Ketamine Infusion During Burn Wound Care

A Phase 4 interventional study of Ketamine and 0.9% NaCl in Burn, Pain and Dissociation, sponsored by University of Tennessee. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.

Sponsored by University of Tennessee · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Burn
  • Pain
  • Dissociation
  • Opioid

Keywords

  • ketamine
  • burn
  • opioid
  • analgesia
03

In context

Burns

905 studies on the registry are indexed under Burns; 164 are open to participants now.

This study's planned enrollment of 140 is above the median of 40 across 663 interventional studies indexed under Burns.

Browse Burns studies →

Lead sponsor

University of Tennessee is the lead sponsor of 142 studies on the registry; 21 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Admitted to burn service with thermal injury

Exclusion criteria

Exclusion Criteria:

  • unable/unwilling to consent within 72 hours
  • unable to report NRS
  • known to ketamine
  • \< than 18 years of age
  • pregnant
  • incarcerated
  • TBSA over 50 %
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
140 participants (estimated)

Study 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.

    Drug: Ketamine

  • Placebo comparator
    Placebo

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

    Drug: 0.9% NaCl

Interventions

  • Infusion during wound care

  • Drug0.9% NaCl

    Infusion during wound care

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Analgesia

    Numeric Pain Rating Scale (0 - 10, with 0 being absence of pain and 10 being the worst pain imaginable)

    Time frame: up to 7 days from enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06506565
Responsible party
Sponsor
First posted
Jul 17, 2024
Start date
Jul 8, 2024
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Dec 13, 2024

Study contacts

David M Hill, Pharm.D.
Contact
dhill19@uthsc.edu
1-901-545-7100

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Ketamine

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