ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03305055
Recruitment Status : Not yet recruiting
First Posted : October 9, 2017
Last Update Posted : October 9, 2017
Sponsor:
Collaborators:
United States Department of Defense
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
Johns Hopkins University

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).

Condition or disease Intervention/treatment Phase
Acute Pain Wound Care Posttraumatic Stress Disorder Drug: ketamine Drug: Fentanyl Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled, repeated exposure (twice daily, 7 days), safety and efficacy trial of Usual Care (fentanyl) versus Usual Care plus Study Drug Augmentation (ketamine) in reducing acute pain severity during wound care for acute burn injury in the Burn Center of an Academic Medical Center.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Pharmacy receives order from provider and then prepares the study drug in an unmarked, nondescript delivery system that is timed and volume controlled. This is hung next to patient, connected and started. Masked personnel include provider, nurse, and patient.
Primary Purpose: Treatment
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.
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fentanyl Plus Ketamine

STUDY GROUP (USUAL CARE/FENTANYL PLUS KETAMINE - "study drug")

i. Fentanyl Loading Dose = 1 mcg / kg (0.07 mg in a 70 kg individual). This is given to participants in both Groups 1& 2 starting at initiation of wound care.

ii. Ketamine Loading Dose = 0.3 mg/kg (approx. 20 mg of ketamine in a 70 kg patient). Dose to be initiated 10 minutes prior to initiating wound care & infused over 3 minutes.

iii. Ketamine Continuous Infusion = 2.5 mcg/kg/min (approximately 10 mg/hr in a 70 kg patient).

Will start immediately after completion of ketamine loading dose & will continue throughout dressing change.

*FENTANYL PRN DOSE* = 1 mcg / kg. Provided to participants in both Groups 1 & 2 when participant requires additional pain medication.

Drug: ketamine
Information included in arm descriptions

Drug: Fentanyl
Information included in arm descriptions

Active Comparator: Fentanyl Plus Saline

USUAL CARE GROUP (USUAL CARE FENTANYL PLUS SALINE)

i . Fentanyl Loading Dose = 1 mcg / kg (0.07 mg in a 70 kg individual) This is given to participants in both Group 1 and Group 2 starting at initiation of wound care.

ii. Saline Loading Dose (Placebo, Infusion) = An identical volume of saline as that in 0.3 mg/kg of "study drug". This will be initiated in the Usual Care group 10 minutes before the wound care is set to begin and infused over 3 minutes (i.e., during the same time that the "study drug" group receives with the "study drug" loading dose).

iii. Saline (Placebo, Infusion) = identical volume of fluid as that in 2.5 mcg/kg/min of ketamine, initiated immediately following the Saline Loading Dose and continued for the duration of the session.

*FENTANYL PRN DOSE* = 1 mcg / kg. Provided to participants in both Groups 1 & 2 when participant requires additional pain medication.

Drug: Fentanyl
Information included in arm descriptions




Primary Outcome Measures :
  1. Mean Wound Care Pain [ Time Frame: Up to 40 days following study protocol initiation with each participant. ]
    Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment.


Secondary Outcome Measures :
  1. PTSD symptoms, symptom clusters and diagnosis [ Time Frame: protocol day 1 up to 40 days following study protocol initiation. ]
    Severity of PTSD symptoms; Proportion of groups at 1-month meeting PTSD diagnostic criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 7 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 (eg potential drug interactions or medical comorbid conditions)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305055


Contacts
Contact: James A Fauerbach, PhD 410-652-4797 jfauerb1@jhmi.edu
Contact: Emily Werthman, RN (443) 838-7814 ewerthm1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Burn Center Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: James Fauerbach, PhD    410-652-4797    jfauerb1@jhmi.edu   
Contact: Emily Werthman, RN    (443) 838-7814    ewerthm1@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
United States Department of Defense
Congressionally Directed Medical Research Programs
Investigators
Principal Investigator: James A Fauerbach, PhD Johns Hopkins University SOM
Principal Investigator: Kevin Gerold, DOJD Johns Hopkins University SOM
Study Director: Julie Caffrey, DO Johns Hopkins University SOM

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03305055     History of Changes
Other Study ID Numbers: IRB00089761
NTI-NTRR15-13 ( Other Grant/Funding Number: National Trauma Institute; Departement of Defense )
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan not operationalized as of yet.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will become available by 1 year after final data publication and remain available for indefinitely.
Access Criteria: Written request from faculty investigator to PI or Study Director specifying planned safety & monitoring plan and data analytic aims and hypotheses

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Johns Hopkins University:
opioid
ketamine

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Acute Pain
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketamine
Fentanyl
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia