Trial Outcomes & Findings for RCT: Fentanyl Plus Ketamine Versus Fentanyl Alone for Acute Burn Pain (NCT NCT03305055)

Results Overview

Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

Up to 40 days

Results posted on

2019-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	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. ketamine: Information included in arm descriptions Fentanyl: 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. Fentanyl: Information included in arm descriptions
Overall Study STARTED	2	2
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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. ketamine: Information included in arm descriptions Fentanyl: 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. Fentanyl: Information included in arm descriptions
Overall Study Withdrawal by Subject	0	1
Overall Study Adverse Event	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fentanyl Plus Ketamine n=2 Participants 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	Fentanyl Plus Saline n=2 Participants 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 n=4 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 35.4 • n=5 Participants	37 years STANDARD_DEVIATION 15.6 • n=7 Participants	40.5 years STANDARD_DEVIATION 22.7 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 40 days

Population: 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

Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 7-days, within session

Population: 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

Trajectory of average pain within session

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 7-Days across sessions

Population: 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

Trajectory of average pain across 7 day study protocol

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 37 days

Population: Data was not collected for this outcome measure.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 37 days

Population: 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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 37 days

Population: 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

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.

Outcome measures

Outcome data not reported

Adverse Events

Fentanyl Plus Ketamine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Fentanyl Plus Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fentanyl Plus Ketamine n=2 participants at risk 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	Fentanyl Plus Saline n=2 participants at risk 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
Skin and subcutaneous tissue disorders Pain at wound site	50.0% 1/2 • Number of events 1 • End of study (approximately 37 days)	50.0% 1/2 • Number of events 1 • End of study (approximately 37 days)

Additional Information

James A. Fauerbach

Johns Hopkins University

Phone: 410-550-0890

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place