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Trial Outcomes & Findings for Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department (NCT NCT01538745)

NCT ID: NCT01538745

Last Updated: 2021-02-04

Results Overview

Numerical Rating Scale (NRS) pain score is an 11-point rating scale for pain. With 0 being no pain and 10 being the worst pain imaginable.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

45 participants

Primary outcome timeframe

5,10,20,40,60,80,100,120 minutes post dose

Results posted on

2021-02-04

Participant Flow

The study took place at a Level 1 trauma center. The patient population at SAMMC consists of active duty military personnel and their family members, retirees, as well as civilians. There are approximately 75,000 visits to the SAMMC ED annually. Enrollment occurred from February 2012 to March 2013.

Patients were excluded if: O2 saturation \<95%, SBP \< 90mmHg or \> 180mmHg, HR\< 50 or \> 120 beats per minute, RR \< 10 or \> 30 per minute, altered mental status, intoxication, history fibromyalgia, ischemic heart disease, heart failure or unstable dysrhythmias, required pain medication immediately and cannot wait to consent

Participant milestones

Participant milestones
Measure
Ketamine
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Morphine
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Overall Study
STARTED
24
21
Overall Study
COMPLETED
24
21
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ketamine
n=24 Participants
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Morphine
n=21 Participants
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Total
n=45 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
Age, Categorical
Between 18 and 65 years
24 Participants
n=5 Participants
21 Participants
n=7 Participants
45 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
30.75 years
STANDARD_DEVIATION 11.87 • n=5 Participants
29.29 years
STANDARD_DEVIATION 9.78 • n=7 Participants
30.07 years
STANDARD_DEVIATION 10.84 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
12 Participants
n=7 Participants
22 Participants
n=5 Participants
Sex: Female, Male
Male
14 Participants
n=5 Participants
9 Participants
n=7 Participants
23 Participants
n=5 Participants
Region of Enrollment
United States
24 participants
n=5 Participants
21 participants
n=7 Participants
45 participants
n=5 Participants

PRIMARY outcome

Timeframe: 5,10,20,40,60,80,100,120 minutes post dose

Numerical Rating Scale (NRS) pain score is an 11-point rating scale for pain. With 0 being no pain and 10 being the worst pain imaginable.

Outcome measures

Outcome measures
Measure
Ketamine
n=11 units on a scale
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Morphine
n=11 units on a scale
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score
-4.9 NRS pain scale score
Interval -5.75 to -4.0
-5 NRS pain scale score
Interval -7.1 to -2.9

SECONDARY outcome

Timeframe: 5,10, 20,40,60,80,100,120 minutes

Following dosage with study medication, the amount of time taken to demonstrate a change in the patient's NRS pain score. Time to Change in NRS Pain Score for the Reporting Group as a whole will be made

Outcome measures

Outcome measures
Measure
Ketamine
n=24 Participants
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Morphine
n=21 Participants
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Time to Change in NRS Pain Score
5 minutes
Standard Deviation 2.63
5 minutes
Standard Deviation 2.48

SECONDARY outcome

Timeframe: 5, 10, 20 minutes and then every 20 minutes to a total of 120 minutes

Following dosage with study medication, the interval time taken to demonstrate the maximal change in the patient's NRS pain score will be reported for each group.

Outcome measures

Outcome measures
Measure
Ketamine
n=24 Participants
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Morphine
n=21 Participants
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Time to Maximal Change in NRS Pain Score
5 minutes
Standard Deviation 1.7
120 minutes
Standard Deviation 22.2

SECONDARY outcome

Timeframe: 120 minutes

Requiring more than two doses of the study medication provided for adequate pain control

Outcome measures

Outcome measures
Measure
Ketamine
n=24 Participants
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Morphine
n=21 Participants
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Incidence of Treatment Failure
25 Percentage of patients
14 Percentage of patients

SECONDARY outcome

Timeframe: 5,10,20,40,60,80,100,120 minutes

The patient will be assessed for vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation), and all side effects at 5,10,20 minutes following medication administration and then every 20 minutes until a total of 120 minutes from the first dose of study medication. All side effects and outlying vital signs will be documented.

Outcome measures

Outcome measures
Measure
Ketamine
n=24 Participants
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Morphine
n=21 Participants
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Incidence of Side Effects, Including Outlying Vital Signs
58 Percentage of patients
57 Percentage of patients

SECONDARY outcome

Timeframe: 5,10,20,40,60,80,100,120 minutes

Using 0 as the "normal/baseline" on the RASS, maximal deviation in either direction will be used to demonstrate the effect of the study medications on levels of sedation or agitation. Results will be reported as Richmond Agitation Sedation Scale (RASS) scores range from: * 4 Combative: Overtly combative, violent, immediate danger to staff * 3 Very agitated: Pulls or removes tube(s) or catheter(s); aggressive * 2 Agitated: Frequent non-purposeful movement * 1 Restless: Anxious but movements not aggressive. vigorous 0 Alert and calm * 1 Drowsy: Not fully alert, but has sustained awakening (eye-opening/eye contact) to voice (\>10 seconds) * 2 Light sedation: Briefly awakens with eye contact to voice (\<10 seconds) * 3 Moderate sedation: Movement or eye opening to voice (but no eye contact) * 4 Deep sedation: No response to voice, but movement or eye opening to physical stimulation * 5 Unarousable: No response to voice or physical stimulation

Outcome measures

Outcome measures
Measure
Ketamine
n=24 Participants
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG. Ketamine : 0.3 mg/kg ketamine IVP over 5 minutes. Total of two possible doses.
Morphine
n=21 Participants
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG. Morphine : 0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Maximum Deviation From 0 on the Richmond Agitation Sedation Scale (RASS)
0 units on a scale
Interval -3.0 to 3.0
0 units on a scale
Interval -2.0 to 1.0

Adverse Events

Ketamine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Morphine

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

Josh Miller

SAUSHEC

Phone: 210-916-7111

Results disclosure agreements

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