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

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ClinicalTrials.gov Identifier: NCT03305055
Recruitment Status : Terminated (Funding withdrawn - slow enrollment)
First Posted : October 9, 2017
Results First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Collaborators:
United States Department of Defense
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE June 12, 2017
First Posted Date  ICMJE October 9, 2017
Results First Submitted Date  ICMJE February 18, 2019
Results First Posted Date  ICMJE March 12, 2019
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE December 16, 2017
Actual Primary Completion Date March 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
  • Mean Wound Care Pain [ Time Frame: Up to 40 days ]
    Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment.
  • Trajectory of Mean Wound Care Session Pain Within Sessions [ Time Frame: 7-days, within session ]
    Trajectory of average pain within session
  • Trajectory of Mean Wound Care Session Pain Across Sessions [ Time Frame: 7-Days across sessions ]
    Trajectory of average pain across 7 day study protocol
  • Opiate Sparing Effect [ Time Frame: 37 days ]
    Pro Re Nata (PRN) pain management or adjunct expressed in opiate equivalents (e.g., anxiolytic) or premed (e.g., non-protocol medications for pain, anxiety, etc); post-session (1 and 6 hours post session , e.g., pain, anxiolytic, etc).
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
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.
Change History Complete list of historical versions of study NCT03305055 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • Post Traumatic Stress Disorder (PTSD) Symptoms as Assessed by Davidson Trauma Scale [ Time Frame: 37 days ]
    PTSD symptoms score as assessed by Davidson Trauma Scale consisting of 17 items (symptoms) with each item measured for severity and frequency. Each item is rated 0 - 4. Overall score ranges from 0 to 136, with higher scores indicating higher frequency and severity.
  • Depression Symptoms as Assessed by the Patient Health Questionnaire [ Time Frame: 37 days ]
    Severity and trajectory of depression symptoms as assessed by the Patient Health Questionnaire (PHQ) 9. The questionnaire has 9 items with each rated from 0 to 3. Overall scores ranges from 0 to 27 with 1-4 being minimal depression, 5-9 being mild depression, 10-14 being moderate depression, 15-19 being moderately severe depression and 20-27 being severe depression.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain
Official Title  ICMJE Evaluating the Safety, Efficacy and Opiate Sparing Effects of Low-Dose, Slow Infusion Ketamine as a Battlefield Analgesic for Acute Pain in Burn Wounds.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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 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.
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 ("bag") and the study drug information is entered from the bag into the pump so that delivery that is timed and volume controlled per study protocol. This is hung next to patient, connected and started. Masked personnel include provider (order study drug protocol), nurse (wound care), data assessor (Research Assistant), and consenting participant (patient with acute burn).
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Pain
  • Wound Care
  • Posttraumatic Stress Disorder
Intervention  ICMJE
  • Drug: ketamine
    Information included in arm descriptions
    Other Name: STUDY DRUG GROUP (Fentanyl plus Ketamine)
  • Drug: Fentanyl
    Information included in arm descriptions
    Other Name: USUAL CARE GROUP (Fentanyl plus saline/placebo)
Study Arms  ICMJE
  • Experimental: 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.

    Interventions:
    • Drug: ketamine
    • Drug: Fentanyl
  • Active Comparator: 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.

    Intervention: Drug: Fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 22, 2018)
4
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2017)
150
Actual Study Completion Date  ICMJE April 21, 2018
Actual Primary Completion Date March 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03305055
Other Study ID Numbers  ICMJE IRB00089761
NTI-NTRR15-13 ( Other Grant/Funding Number: National Trauma Institute; Departement of Defense )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Plan not operationalized as yet.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • United States Department of Defense
  • Congressionally Directed Medical Research Programs
Investigators  ICMJE
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
PRS Account Johns Hopkins University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP