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Recruiting

NCT Number: NCT06506565

Low-Dose Ketamine Infusion During Burn Wound Care

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.

Recruiting

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Key information

Conditions

Burn Agnosia Burns Dissociation Dissociative Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regional One Health

Memphis, Tennessee, 38103, United States

Location status: Recruiting

Location contact

Yvonne Shaw, RN

CONTACT

[email protected]

901-448-2714

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 %

Treatment and study plan

ketamine

Drug

Infusion during wound care

0.9% NaCl

Drug

Infusion during wound care

Other names: Placebo

Primary outcomes

  1. Analgesia

    Time frame: up to 7 days from enrollment

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

Study contacts

Contact information is provided by the study sponsor or research team.

David M Hill, Pharm.D.

CONTACT

[email protected]

1-901-545-7100

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Registry information

Official study title

A Randomized, Placebo-Controlled, Double-Blind Evaluation of Low-Dose Ketamine Infusion During Burn Wound Care Procedures to Improve Pain Intensity and Reduce Opioid Consumption

Acronym: IMPROVE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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