Trial Outcomes & Findings for Low Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department (NCT NCT01835262)

Results Overview

We will compare efficacy as a difference between 2 groups in pain score at 30 minutes post-analgesic administration. The primary outcome is the difference between 2 groups in pain score at 30 minutes. Pain will be measured via Numeric rating scale from 0 to 10 with 0 being no pain, 5 being moderate pain, and 10 being severe pain

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

90 participants

Primary outcome timeframe

30 minutes

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Morphine Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP Morphine: Morphine: 0.1 mg /kg given as IVP	Ketamine Group Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP Ketamine: Ketamine:0.3 mg/given as IVP
Overall Study STARTED	45	45
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Dose Ketamine Versus Morphine for Moderate to Severe Pain in the Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Morphine n=45 Participants Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP Morphine: Morphine: 0.1 mg /kg given as IVP	Ketamine Group n=45 Participants Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP Ketamine: Ketamine:0.3 mg/given as IVP	Total n=90 Participants Total of all reporting groups
Age, Continuous	35.7 years STANDARD_DEVIATION 10.5 • n=5 Participants	34.8 years STANDARD_DEVIATION 9.5 • n=7 Participants	35.0 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants
Numeric Rating Scale of Pain score	8.49 score STANDARD_DEVIATION 1.5 • n=5 Participants	8.64 score STANDARD_DEVIATION 1.5 • n=7 Participants	8.57 score STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes

We will compare efficacy as a difference between 2 groups in pain score at 30 minutes post-analgesic administration. The primary outcome is the difference between 2 groups in pain score at 30 minutes. Pain will be measured via Numeric rating scale from 0 to 10 with 0 being no pain, 5 being moderate pain, and 10 being severe pain

Outcome measures

Outcome measures
Measure	Morphine n=45 Participants Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP Morphine: Morphine: 0.1 mg /kg given as IVP	Ketamine Group n=45 Participants Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP Ketamine: Ketamine:0.3 mg/given as IVP
Numeric Rating Scale of Pain	3.93 Units on a scale Standard Deviation 3.1	4.07 Units on a scale Standard Deviation 3.2

Adverse Events

Morphine

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Ketamine Group

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Morphine n=45 participants at risk Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP Morphine: Morphine: 0.1 mg /kg given as IVP	Ketamine Group n=45 participants at risk Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP Ketamine: Ketamine:0.3 mg/given as IVP
General disorders Dizziness	13.3% 6/45 • Number of events 6 • Within 2 hours of administration of either morphine or ketamine	17.8% 8/45 • Number of events 8 • Within 2 hours of administration of either morphine or ketamine
Gastrointestinal disorders Nausea	20.0% 9/45 • Number of events 9 • Within 2 hours of administration of either morphine or ketamine	13.3% 6/45 • Number of events 6 • Within 2 hours of administration of either morphine or ketamine

Additional Information

Antonios Likourezos

Maimonides Medical Center

Phone: 718-283-6896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place