Burn, Dissociation, Opioid, Pain
Conditions
Keywords
ketamine, burn, opioid, analgesia
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.
Interventions
DRUGKetamine
Infusion during wound care
DRUG0.9% NaCl
Infusion during wound care
Sponsors
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All team members and patients are blinded to study treatment, except pharmacy staff.
Intervention model description
Patients will be randomly enrolled by blocks according to age, burn size, and opioid use history. Study treatment will occur for up to 7 days. Assignment will be to placebo or ketamine and all participants and staff will be blinded, except pharmacy. Each patient will receive standard of care fentanyl and midazolam during wound care regardless of study assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 %
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia | 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) |
Countries
United States
Contacts
Primary ContactDavid M Hill, Pharm.D.
Outcome results
None listed