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

NCT ID: NCT03305055

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-16
• Study Completion Date: 2018-04-21

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.

Conditions

Acute Pain; Wound Care; Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fentanyl Plus Ketamine

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.

Group Type: EXPERIMENTAL

ketamine

Intervention Type: DRUG

Information included in arm descriptions

Fentanyl

Intervention Type: DRUG

Information included in arm descriptions

Fentanyl Plus Saline

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.

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

Information included in arm descriptions

Interventions

ketamine

Information included in arm descriptions

Intervention Type: DRUG

Fentanyl

Information included in arm descriptions

Intervention Type: DRUG

Other Intervention Names

STUDY DRUG GROUP (Fentanyl plus Ketamine); USUAL CARE GROUP (Fentanyl plus saline/placebo)

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James A Fauerbach, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University SOM

Kevin Gerold, DOJD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University SOM

Julie Caffrey, DO

Role: STUDY_DIRECTOR

Johns Hopkins University SOM

Locations

Johns Hopkins Burn Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NTI-NTRR15-13

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00089761

Identifier Type: -

Identifier Source: org_study_id