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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Recruitment Status : Terminated (Funding withdrawn - slow enrollment)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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Acute Pain
Wound Care
Posttraumatic Stress Disorder
Interventions Drug: ketamine
Drug: Fentanyl
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fentanyl Plus Ketamine Fentanyl Plus Saline
Hide Arm/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.

ketamine: Information included in arm descriptions

Fentanyl: Information included in arm descriptions

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.

Fentanyl: Information included in arm descriptions

Period Title: Overall Study
Started 2 2
Completed 1 0
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             0             1
Adverse Event             1             1
Arm/Group Title Fentanyl Plus Ketamine Fentanyl Plus Saline Total
Hide Arm/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.

ketamine: Information included in arm descriptions

Fentanyl: Information included in arm descriptions

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.

Fentanyl: Information included in arm descriptions

Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
44  (35.4) 37  (15.6) 40.5  (22.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
1
  50.0%
0
   0.0%
1
  25.0%
Male
1
  50.0%
2
 100.0%
3
  75.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
 100.0%
2
 100.0%
4
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
Title Mean Wound Care Pain
Hide Description Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment.
Time Frame Up to 40 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure
Arm/Group Title Fentanyl Plus Ketamine Fentanyl Plus Saline
Hide Arm/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.

ketamine: Information included in arm descriptions

Fentanyl: Information included in arm descriptions

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.

Fentanyl: Information included in arm descriptions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Trajectory of Mean Wound Care Session Pain Within Sessions
Hide Description Trajectory of average pain within session
Time Frame 7-days, within session
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure
Arm/Group Title Fentanyl Plus Ketamine Fentanyl Plus Saline
Hide Arm/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.

ketamine: Information included in arm descriptions

Fentanyl: Information included in arm descriptions

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.

Fentanyl: Information included in arm descriptions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Trajectory of Mean Wound Care Session Pain Across Sessions
Hide Description Trajectory of average pain across 7 day study protocol
Time Frame 7-Days across sessions
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure
Arm/Group Title Fentanyl Plus Ketamine Fentanyl Plus Saline
Hide Arm/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.

ketamine: Information included in arm descriptions

Fentanyl: Information included in arm descriptions

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.

Fentanyl: Information included in arm descriptions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Opiate Sparing Effect
Hide Description 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).
Time Frame 37 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure.
Arm/Group Title Fentanyl Plus Ketamine Fentanyl Plus Saline
Hide Arm/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.

ketamine: Information included in arm descriptions

Fentanyl: Information included in arm descriptions

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.

Fentanyl: Information included in arm descriptions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Post Traumatic Stress Disorder (PTSD) Symptoms as Assessed by Davidson Trauma Scale
Hide Description 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.
Time Frame 37 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure
Arm/Group Title Fentanyl Plus Ketamine Fentanyl Plus Saline
Hide Arm/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.

ketamine: Information included in arm descriptions

Fentanyl: Information included in arm descriptions

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.

Fentanyl: Information included in arm descriptions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Depression Symptoms as Assessed by the Patient Health Questionnaire
Hide Description 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.
Time Frame 37 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure
Arm/Group Title Fentanyl Plus Ketamine Fentanyl Plus Saline
Hide Arm/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.

ketamine: Information included in arm descriptions

Fentanyl: Information included in arm descriptions

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.

Fentanyl: Information included in arm descriptions

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame End of study (approximately 37 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fentanyl Plus Ketamine Fentanyl Plus Saline
Hide Arm/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.

ketamine: Information included in arm descriptions

Fentanyl: Information included in arm descriptions

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.

Fentanyl: Information included in arm descriptions

All-Cause Mortality
Fentanyl Plus Ketamine Fentanyl Plus Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Fentanyl Plus Ketamine Fentanyl Plus Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fentanyl Plus Ketamine Fentanyl Plus Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      1/2 (50.00%)    
Skin and subcutaneous tissue disorders     
Pain at wound site *  1/2 (50.00%)  1 1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: James A. Fauerbach
Organization: Johns Hopkins University
Phone: 410-550-0890
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 Submitted: June 12, 2017
First Posted: October 9, 2017
Results First Submitted: February 18, 2019
Results First Posted: March 12, 2019
Last Update Posted: March 12, 2019