Trial Outcomes & Findings for Ketamine vs Hydromorphone (NCT NCT03001843)

Last Updated: 2021-03-09

Results Overview

Used to translate the dose and route of each of the opioids the patient has received over the last 48 hours to a parenteral morphine equivalent using a standard conversion table. SD standard deviation, mg: milligrams, pain measured on a 0-10 scale

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

48 hours

Results posted on

2021-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	Non-Ketamine This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain	Ketamine This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain. Ketamine: Anesthesia of only Ketamine pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain
Overall Study STARTED	27	27
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Ketamine n=27 Participants This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain	Ketamine n=27 Participants This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain. Ketamine: Anesthesia of only Ketamine pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Age, Categorical Between 18 and 65 years	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Age, Categorical >=65 years	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Sex: Female, Male Female	21 Participants n=27 Participants	23 Participants n=27 Participants	44 Participants n=54 Participants
Sex: Female, Male Male	6 Participants n=27 Participants	4 Participants n=27 Participants	10 Participants n=54 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Race (NIH/OMB) Asian	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Race (NIH/OMB) Black or African American	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Race (NIH/OMB) White	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Race (NIH/OMB) More than one race	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Race (NIH/OMB) Unknown or Not Reported	0 Participants Data not collected	0 Participants Data not collected	0 Participants Data not collected
Region of Enrollment United States	27 participants n=27 Participants	27 participants n=27 Participants	54 participants n=54 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	Non-Ketamine n=27 Participants This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain	Ketamine n=27 Participants This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain. Ketamine: Anesthesia of only Ketamine pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain
Pain Measured Based on Pain Medication Used on a Scale of 0-10	1.3 units on a scale Standard Deviation 2.2	0.7 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: 48 hours

Length of stay compared between the 2 groups in hours.

Outcome measures

Outcome measures
Measure	Non-Ketamine n=27 Participants This group will receive intraoperative narcotics as is usually done for this surgery. This arm will not receive Ketamine. Narcotics: The narcotic group will receive no ketamine but rather a more standard anesthetic pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain	Ketamine n=27 Participants This group will receive an intraoperative infusion of ketamine rather than narcotics to control pain. Ketamine: Anesthesia of only Ketamine pain scale: 0-10 pain scale. 0 = no pain and 10 = worst pain
Length of Stay (Hours)	43.6 hours Standard Deviation 20.6	39.8 hours Standard Deviation 14.5

Adverse Events

Non-Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Joshua Sappenfield, MD

University of Florida

Phone: 352-273-5259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place