TerminatedPhase 4ketamine

RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain

NCT ID

NCT03305055

Target Enrollment

4 participants

Start Date

2017-12-16

Est. Completion

2018-04-21

About This Study

The Ketamine for Acute Pain in Burns study is a randomized, double-blind, parallel group trial (RCT) with active control (usual care) contrasting the efficacy and safety of "Ketamine Plus Opiate-based usual care" (O+K) with the safety and efficacy of the "Current Standard of Care". THe current standard of care is an opiate medication alone, Fentanyl (Usual Care-Opiate (UC-O), dose/timing as per Burn Center protocol).

Conditions Studied

Acute PainWound CarePosttraumatic Stress Disorder

Interventions

•ketamine
•Fentanyl

Eligibility

Age:18 Years - 70 Years

Healthy Volunteers:No

View full eligibility criteria

Inclusion Criteria:

* Total Body Surface Area (TBSA) greater than or equal to 2%; Less than or equal to 40% TBSA
* English speaking
* pain in emergency room during initial wound evaluation (on admission) greater than 5 /10
* estimated length of stay greater than or equal to 5 days

Exclusion Criteria:

* requiring endotracheal intubation and sedation,
* severe hearing impairment,
* cognitive impairment status - Mini-Mental State Examination (MMSE) \</=20,
* diminished capacity unable to provide informed consent;
* Past Medical History (PMH): insensate (eg. spinal cord injury, peripheral neuropathy)
* Safety: contraindication (e.g., potential drug interactions or medical comorbidities)

Study Locations (1)

Johns Hopkins Burn Center