Trial Outcomes & Findings for Ketamine Patient-Controlled Analgesia for Acute Pain (NCT NCT02062879)

NCT ID: NCT02062879

Last Updated: 2017-09-21

Results Overview

Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 20 participants
• Primary outcome timeframe: Participants will be followed for their entire hospital stay, an expected average of 1 week.
• Results posted on: 2017-09-21

Participant Flow

Participant milestones

Measure	Ketamine Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Overall Study STARTED	10	10
Overall Study COMPLETED	6	9
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Ketamine Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Overall Study Withdrawal by Subject	4	1

Baseline Characteristics

Ketamine Patient-Controlled Analgesia for Acute Pain

Baseline characteristics by cohort

Measure	Ketamine n=10 Participants Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone n=10 Participants Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.	Total n=20 Participants Total of all reporting groups
Age, Continuous	39 years n=5 Participants	26 years n=7 Participants	30 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
BMI	27 kg/m^2 n=5 Participants	26.5 kg/m^2 n=7 Participants	27 kg/m^2 n=5 Participants
Injury Severity Score	29 scores on a scale n=5 Participants	28 scores on a scale n=7 Participants	29 scores on a scale n=5 Participants
Blunt Trauma	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Penetrating Trauma	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Participants will be followed for their entire hospital stay, an expected average of 1 week.

Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents

Outcome measures

Measure	Ketamine n=10 Participants Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone n=10 Participants Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Total Daily Opioid Requirement	10 mg morphine equivalents/day Interval 4.2 to 15.0	42.5 mg morphine equivalents/day Interval 31.7 to 62.0

SECONDARY outcome

Timeframe: Participants will be followed for their entire hospital stay, an expected average of 1 week

Breakthrough daily opioid requirement in milligrams of morphine equivalents/day

Outcome measures

Measure	Ketamine n=10 Participants Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone n=10 Participants Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Breakthrough Daily Opioid Requirement	10 mg morphine equivalents/day Interval 0.63 to 19.38	10 mg morphine equivalents/day Interval 4.38 to 22.5

SECONDARY outcome

Timeframe: Participants will be followed for their entire hospital stay, an expected average of 1 week

Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.

Outcome measures

Measure	Ketamine n=10 Participants Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone n=10 Participants Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Median Pain Score	6.3 scores on a scale Interval 4.0 to 7.5	5.3 scores on a scale Interval 3.0 to 6.8

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Hydromorphone

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ketamine n=10 participants at risk Ketamine 90mg/30 mL PCA (3 mg/mL) Ketamine: Ketamine administered as patient-controlled analgesia.	Hydromorphone n=10 participants at risk Hydromorphone 6mg/30 mL PCA (0.2 mg/mL) Hydromorphone: Hydromorphone administered as patient-controlled analgesia.
Psychiatric disorders Hallucinations	40.0% 4/10	0.00% 0/10
Gastrointestinal disorders Nausea	50.0% 5/10	30.0% 3/10
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/10	40.0% 4/10

Additional Information

Sheila Takieddine

UC Health University of Cincinnati Medical Center

Phone: 513-585-6195

Email: Sheila.Takieddine@UCHealth.com

Results disclosure agreements

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