Clinical trial NCT03305055: RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain
Official title: Evaluating the Safety, Efficacy and Opiate Sparing Effects of Low-Dose, Slow Infusion Ketamine as a Battlefield Analgesic for Acute Pain in Burn Wounds.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Pain
Wound Care
Posttraumatic Stress Disorder
Keywords: opioid
ketamine
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Congressionally Directed Medical Research Programs
First posted: 2017-10-09
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, repeated exposure (twice daily, 7 days), safety and efficacy trial of Usual Care (fentanyl PLUS saline / placebo) versus Usual Care plus Study Drug Augmentation (fentanyl PLUS ketamine) in reducing acute pain severity assessed before, during and after wound care for acute burn injury in the Burn Center of an Academic Medical Center.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Department of Defense (DoD) and the U.S. Army Medical Research and Materiel Command (USAMRMC) are funding this RCT for the following reasons:

Primary Aims:

1. To evaluate the safety and efficacy of fentanyl (usual care) + placebo versus fentanyl + ketamine (low-dose, sub-anesthetic, slow-infusion) during twice daily burn wound care across a 7-day study period and 30 day outcome period.
2. To evaluate the opiate sparing effect of fentanyl (usual care) + placebo versus fentanyl + ketamine (low-dose, sub-anesthetic, slow-infusion) during the 7-day study period and 30 day outcome period.

and

Secondary Aims:

1. To determine the short and long term effect of the Ketamine Augmentation Condition versus the Usual Care Condition on symptoms and syndromes of posttraumatic stress disorder and of depression,
2. To evaluate several established and hypothesized moderators of the relationship between the Ketamine Augmentation Condition versus the Usual Care Condition on: 1) pain severity reported during wound care, 2) opiate use during wound care, 3) posttraumatic stress and 4) depression.

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)

Primary outcomes:
measure: Mean Wound Care Pain
timeFrame: Up to 40 days
measure: Trajectory of Mean Wound Care Session Pain Within Sessions
timeFrame: 7-days, within session
measure: Trajectory of Mean Wound Care Session Pain Across Sessions
timeFrame: 7-Days across sessions
measure: Opiate Sparing Effect
timeFrame: 37 days
Secondary outcomes:
measure: Post Traumatic Stress Disorder (PTSD) Symptoms as Assessed by Davidson Trauma Scale
timeFrame: 37 days
measure: Depression Symptoms as Assessed by the Patient Health Questionnaire
timeFrame: 37 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Burn Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University SOM
name: James A Fauerbach, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University SOM
name: Kevin Gerold, DOJD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University SOM
name: Julie Caffrey, DO
role: STUDY_DIRECTOR
References: