Trial Outcomes & Findings for Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department (NCT NCT01900847)

Results Overview

Pain 0-10 with 0 being no pain and 10 being the worst pain

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug

Results posted on

2023-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Morphine and Placebo Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy Morphine: Dosage of morphine determined by treating physician placebo: saline of same volume as appropriate weight based dose of ketamine	Morphine and Ketamine Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care Ketamine: 0.3mg/kg ketamine Morphine: Dosage of morphine determined by treating physician
Overall Study STARTED	10	7
Overall Study COMPLETED	10	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine and Morphine Versus Morphine Alone for the Treatment of Acute Pain in the Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morphine and Placebo n=10 Participants Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy Morphine: Dosage of morphine determined by treating physician placebo: saline of same volume as appropriate weight based dose of ketamine	Morphine and Ketamine n=7 Participants Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care Ketamine: 0.3mg/kg ketamine Morphine: Dosage of morphine determined by treating physician	Total n=17 Participants Total of all reporting groups
Age, Customized > 18 years	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants
Sex/Gender, Customized Females and males	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	7 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (zero minutes), 30 minutes and 1 hour after receiving study drug

Pain 0-10 with 0 being no pain and 10 being the worst pain

Outcome measures

Outcome measures
Measure	Morphine and Placebo n=10 Participants Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy Morphine: Dosage of morphine determined by treating physician placebo: saline of same volume as appropriate weight based dose of ketamine	Morphine and Ketamine n=7 Participants Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care Ketamine: 0.3mg/kg ketamine Morphine: Dosage of morphine determined by treating physician
Numeric Pain Score time 0	6.9 score on a scale Standard Deviation 2.9	7.3 score on a scale Standard Deviation 1.4
Numeric Pain Score 30 min	7.7 score on a scale Standard Deviation 2.0	3.7 score on a scale Standard Deviation 2.8
Numeric Pain Score 60 min	6.8 score on a scale Standard Deviation 1.6	4.9 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)

Outcome measures

Outcome measures
Measure	Morphine and Placebo n=10 Participants Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy Morphine: Dosage of morphine determined by treating physician placebo: saline of same volume as appropriate weight based dose of ketamine	Morphine and Ketamine n=7 Participants Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care Ketamine: 0.3mg/kg ketamine Morphine: Dosage of morphine determined by treating physician
Total Amount of Morphine and Other Pain Medications Administered	9 mg Standard Deviation 5.3	10.3 mg Standard Deviation 5.9

SECONDARY outcome

Timeframe: Data collected from the duration of the patient's Emergency Department stay (expected average 5 hours)

Outcome measures

Outcome measures
Measure	Morphine and Placebo n=10 Participants Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy Morphine: Dosage of morphine determined by treating physician placebo: saline of same volume as appropriate weight based dose of ketamine	Morphine and Ketamine n=7 Participants Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care Ketamine: 0.3mg/kg ketamine Morphine: Dosage of morphine determined by treating physician
Number of Participants With Adverse Events	4 Participants	4 Participants

Adverse Events

Morphine and Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Morphine and Ketamine

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Morphine and Placebo n=10 participants at risk Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy Morphine: Dosage of morphine determined by treating physician placebo: saline of same volume as appropriate weight based dose of ketamine	Morphine and Ketamine n=7 participants at risk Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care Ketamine: 0.3mg/kg ketamine Morphine: Dosage of morphine determined by treating physician
Psychiatric disorders severe dysphoric reaction	0.00% 0/10	14.3% 1/7
General disorders adverse event not specified	40.0% 4/10	42.9% 3/7

Additional Information

Jaiva Larsen

University of Arizona

Phone: 5039396612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place