Trial Outcomes & Findings for A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion (NCT NCT03274453)

Results Overview

Hydromorphone use during the first postoperative 24 hours in mg/kg

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

24 Hours

Results posted on

2018-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Naive Placebo Saline will be administered at the same rate as the ketamine infusion.	Naive Ketamine After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine. Infusion will be maintained for 24 hours.	Tolerant Placebo Saline will be administered at the same rate as the ketamine infusion.	Tolerant Ketamine After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine. Infusion will be maintained for 24 hours.
Overall Study STARTED	38	30	32	29
Overall Study COMPLETED	34	24	28	25
Overall Study NOT COMPLETED	4	6	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Naive Placebo Saline will be administered at the same rate as the ketamine infusion.	Naive Ketamine After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine. Infusion will be maintained for 24 hours.	Tolerant Placebo Saline will be administered at the same rate as the ketamine infusion.	Tolerant Ketamine After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine. Infusion will be maintained for 24 hours.
Overall Study Lost to Follow-up	2	5	4	1
Overall Study Physician Decision	2	0	0	3
Overall Study Surgery Cancelled	0	1	0	0

Baseline Characteristics

A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naive Placebo n=34 Participants Saline will be administered at the same rate as the ketamine infusion.	Naive Ketamine n=24 Participants After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine. Infusion will be maintained for 24 hours.	Tolerant Placebo n=28 Participants Saline will be administered at the same rate as the ketamine infusion.	Tolerant Ketamine n=25 Participants After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine. Infusion will be maintained for 24 hours.	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	24 Participants n=7 Participants	28 Participants n=5 Participants	25 Participants n=4 Participants	111 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex/Gender, Customized Sex · Male	15 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants	13 Participants n=4 Participants	53 Participants n=21 Participants
Sex/Gender, Customized Sex · Female	19 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	58 Participants n=21 Participants

PRIMARY outcome

Timeframe: 24 Hours

Hydromorphone use during the first postoperative 24 hours in mg/kg

Outcome measures

Outcome measures
Measure	Naive Placebo n=34 Participants Saline will be administered at the same rate as the ketamine infusion.	Naive Ketamine n=24 Participants After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine. Infusion will be maintained for 24 hours.	Tolerant Placebo n=28 Participants Saline will be administered at the same rate as the ketamine infusion.	Tolerant Ketamine n=25 Participants After an initial bolus of 0.2 mg/kg, the dose will be fixed at 0.12 mg/kg/hr of ketamine. Infusion will be maintained for 24 hours.
Hydromorphone Use/24 Hours postOP in mg/kg	.13 mg/kg Interval 0.06 to 0.18	.09 mg/kg Interval 0.05 to 0.15	.27 mg/kg Interval 0.2 to 0.37	.19 mg/kg Interval 0.16 to 0.24

Adverse Events

Naive Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Naive Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tolerant Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tolerant Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kirsten Boenigk

New York University School of Medicine

Phone: 212 598 6085

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place