Trial Outcomes & Findings for Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia (NCT NCT01325493)

NCT ID: NCT01325493

Last Updated: 2016-01-14

Results Overview

Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 54 participants
• Primary outcome timeframe: at 24, 48, 72, 96 hours post operatively
• Results posted on: 2016-01-14

Participant Flow

Participant milestones

Measure	Ketamine Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.	Saline Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Overall Study STARTED	30	24
Overall Study COMPLETED	29	21
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Ketamine Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.	Saline Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Overall Study Protocol Violation	0	1
Overall Study loss of neuromonitoring signals	0	2
Overall Study Allergy	1	0

Baseline Characteristics

Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia

Baseline characteristics by cohort

Measure	Ketamine n=29 Participants Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.	Saline n=21 Participants Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.	Total n=50 Participants Total of all reporting groups
Age, Continuous	14 years n=93 Participants	14 years n=4 Participants	14 years n=27 Participants
Sex: Female, Male Female	24 Participants n=93 Participants	14 Participants n=4 Participants	38 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	7 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment United States	29 participants n=93 Participants	21 participants n=4 Participants	50 participants n=27 Participants
American Society of Anesthesiology classification ASA 1	13 participants n=93 Participants	14 participants n=4 Participants	27 participants n=27 Participants
American Society of Anesthesiology classification ASA 2	15 participants n=93 Participants	7 participants n=4 Participants	22 participants n=27 Participants
American Society of Anesthesiology classification ASA 3	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants

PRIMARY outcome

Timeframe: at 24, 48, 72, 96 hours post operatively

Morphine consumption (mg/kg) was measured over time in the Ketamine group and compared to the Control (saline) group. Values are for each 24 hour time period and displayed as hours post surgery.

Outcome measures

Measure	Ketamine n=29 Participants Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.	Saline n=21 Participants Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Morphine Equivalent Consumption (mg/kg) 24 hrs after surgery	1.3 mg/kg Standard Deviation .3	1.36 mg/kg Standard Deviation .42
Morphine Equivalent Consumption (mg/kg) 48 hrs after surgery	1.28 mg/kg Standard Deviation .26	1.275 mg/kg Standard Deviation .31
Morphine Equivalent Consumption (mg/kg) 72 hrs after surgery	.89 mg/kg Standard Deviation .55	.93 mg/kg Standard Deviation .36
Morphine Equivalent Consumption (mg/kg) 96 hrs after surgery	.57 mg/kg Standard Deviation .44	.38 mg/kg Standard Deviation .35

SECONDARY outcome

Timeframe: 24, 48, 72, 96 hours post operatively

Sedation scores 0 = completely awake

1. = sleepy but responds appropriately

2. = somnolent but arouses to light stimuli

3. = asleep but responsive to deeper physical stimuli

4. = asleep and not responsive to any stimuli Values are for each 24 hour time period and displayed as hours post surgery.

Outcome measures

Measure	Ketamine n=29 Participants Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.	Saline n=21 Participants Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Sedation Score 72 hrs after surgery	.38 Sedation Score Standard Deviation .45	.3 Sedation Score Standard Deviation .84
Sedation Score 96 hrs after surgery	.24 Sedation Score Standard Deviation .43	.21 Sedation Score Standard Deviation .39
Sedation Score 24 hrs after surgery	.73 Sedation Score Standard Deviation .68	.75 Sedation Score Standard Deviation .73
Sedation Score 48 hrs after surgery	.62 Sedation Score Standard Deviation .8	.54 Sedation Score Standard Deviation .85

SECONDARY outcome

Timeframe: 24, 48, 72, 96 hours post operatively

Patient volunteered response at rest, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.

Outcome measures

Measure	Ketamine n=29 Participants Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.	Saline n=21 Participants Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Pain Score at Rest 24 hrs after surgery	3.9 pain score at rest Standard Deviation 2.1	4.55 pain score at rest Standard Deviation 2.0
Pain Score at Rest 48 hrs after surgery	4.53 pain score at rest Standard Deviation 1.69	5.2 pain score at rest Standard Deviation 2.2
Pain Score at Rest 72 hrs after surgery	3.6 pain score at rest Standard Deviation 2.3	3.48 pain score at rest Standard Deviation 2.0
Pain Score at Rest 96 hrs after surgery	4.48 pain score at rest Standard Deviation 2.1	3.8 pain score at rest Standard Deviation 1.8

SECONDARY outcome

Timeframe: 24, 48, 72, 96 hours post operatively

Patient volunteered response during a cough, 1-10 scale (where a higher score indicates more pain and a lower score indicates less pain). Values are for each 24 hour time period and displayed as hours post surgery.

Outcome measures

Measure	Ketamine n=29 Participants Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.	Saline n=21 Participants Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Pain Score During Cough. 24 hrs after surgery	4.5 pain score at cough Standard Deviation 2.5	5.1 pain score at cough Standard Deviation 3.0
Pain Score During Cough. 48 hrs after surgery	5.4 pain score at cough Standard Deviation 2.3	5.45 pain score at cough Standard Deviation 2.7
Pain Score During Cough. 72 hrs after surgery	4.4 pain score at cough Standard Deviation 2.3	3.7 pain score at cough Standard Deviation 2.5
Pain Score During Cough. 96 hrs after surgery	5.15 pain score at cough Standard Deviation 2.5	4.2 pain score at cough Standard Deviation 2

Adverse Events

Ketamine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ketamine n=29 participants at risk Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg\*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.	Saline n=21 participants at risk Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
Surgical and medical procedures Allergy	3.4% 1/29 • Number of events 1 • the duration of the study (96 hrs) post surgery	0.00% 0/21 • the duration of the study (96 hrs) post surgery

Other adverse events

Adverse event data not reported

Additional Information

Julia Finkel

Children's National Health System

Phone: 2024764867

Email: JFINKEL@childrensnational.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place