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

Johns Hopkins University

Status and phase: Terminated; Phase 4

Conditions: Posttraumatic Stress Disorder; Wound Care; Acute Pain

Treatments: Drug: Fentanyl; Drug: ketamine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03305055

IRB00089761

NTI-NTRR15-13 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4 participants in 2 patient groups

Fentanyl Plus Ketamine

Experimental group

Description:

Study drug group 1. Ketamine Loading Dose (Low Dose, Slow Infusion) = • 0.3 mg/kg; Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, ... Then, 2. Fentanyl Loading Dose (UC, injection) = • 1 mcg / kg. This is given to participants in both Group 1 and Group 2 initiated \< 1 minute prior to wound care. 3. Ketamine (Study Drug, Infusion) = • 2.5 mcg/kg/min, Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion. Fentanyl PRN dose\* = 1 mcg / kg. Provided when participant requires additional pain medication.

Treatment:

Drug: ketamine

Drug: Fentanyl

Fentanyl Plus Saline

Active Comparator group

Description:

Usual care group 1. Saline Loading Dose (Low Dose, Slow Infusion) = • An identical volume of saline as that in 0.3 mg/kg of ketamine. Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, (i.e., same time/rate as STUDY DRUG GROUP receives ketamine loading dose), ... Then, ... 2. Fentanyl Loading Dose (UC, injection) = • 1 mcg / kg: This is given to participants in both Group 1 and Group 2 initiated \<1 minute prior to wound care. 3. Saline (Placebo, Infusion) = • Identical volume of fluid as that in 2.5 mcg/kg/min of ketamine; Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion. FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication.

Treatment:

Drug: Fentanyl