A Phase 4 interventional study of Ketamine and Morphine in Abdomen, Acute, Other Acute Pain and Flank Pain, sponsored by Brooke Army Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Brooke Army Medical Center · Phase 4, Interventional, and Treatment
The purpose of this study is to compare the safety and effectiveness of intravenous low dose ketamine (LDK) to the industry standard of morphine (MOR) in regards to controlling acute pain in the emergency department.
Both LDK and morphine have side effects. The amount and character of these side effects will be compared. Additionally, the degree of sedation or agitation will be specifically measured. The aim of this current study is to make this comparison and shift the evidence for LDK use from the anecdotal to the scientific.
Phase 1 is a randomized, controlled, double-blinded study comparing the use of low-dose ketamine (LDK) to morphine for acute pain control in emergency department patients. A convenience sample of subjects will be enrolled from a population of patients aged 18-50 who present to the Brooke Army Medical Center Emergency Department with acute abdominal pain, flank/lumbar back pain and/or pain to the extremities. To take part in the study, a need for opioid analgesia must be indicated by the treating physician in addition to the patient meeting all other study criteria.
The patient will then be randomized into one of the two treatment arms. Prior to receiving either the study medication (ketamine) or the active control (morphine) the patient will be asked to rate their pain on a numeric rating scale (NRS) with 0 being no pain and 10 being the worst pain possible. Their baseline vital signs (blood pressure, heart rate, respiratory rate and oxygen saturation) will also be documented. These vital signs and the NRS will be reassessed at 5, 10 and 20 minutes post medication dosage. At 20 minutes they will also document a Richmond Agitation Sedation Scale (RASS) score and will ask the patient if they require additional pain medication. If the patient denies the need for a second dose of medication they will continue to be re-assessed every 20 minutes (vital signs, NRS, and RASS) until either inpatient admission, discharge home, transfer to the operating room or until a total of 120 minutes after initial dosing.
If at any time during the study the patient requires a second dose of pain medication, following the administration of the med, they will be assessed for vital signs at 5,10 and 20 minutes after the dose. At 20 minutes, a RASS score and NRS score will also be documented. They will then be re-assessed every 20 minutes (vital signs, NRS, and RASS) until either inpatient admission, discharge home, transfer to the operating room or until a total of 120 minutes after initial dosing.
If they require a third dose of pain medication at any time during the study, this is considered a treatment failure and the treating physician will be contacted to provide any further pain control.
The second phase of the study will be observational. An anonymous satisfaction survey will be provided to the treating nurse, physician or physicians assistant (PA) of the patients recruited from part one of the study. The purpose of conducting the survey is so that an observation point of view can be added to the data to provide a measure of how well the patient's pain was controlled.
493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 45 is below the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →Brooke Army Medical Center is the lead sponsor of 92 studies on the registry; 11 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.3 MG/KG IV KETAMINE ADMINISTERED OVER 5 MINUTES. MAX DOSE OF 25MG.
Drug: Ketamine
0.1 MG/KG IV MORPHINE ADMINSITERED OVER 5 MINUTES. MAX DOSE 8MG.
Drug: Morphine
0.3 mg/kg ketamine Intravenous push (IVP) over 5 minutes. Total of two possible doses.
Also known as: Ketalar
0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
Also known as: MS Contin, Roxanol, Kadian, Avinza
Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score
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.
Time frame: 5,10,20,40,60,80,100,120 minutes post dose
Time to Change in NRS Pain Score
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
Time frame: 5,10, 20,40,60,80,100,120 minutes
Time to Maximal Change in NRS Pain Score
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.
Time frame: 5, 10, 20 minutes and then every 20 minutes to a total of 120 minutes
Incidence of Treatment Failure
Requiring more than two doses of the study medication provided for adequate pain control
Time frame: 120 minutes
Incidence of Side Effects, Including Outlying Vital Signs
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.
Time frame: 5,10,20,40,60,80,100,120 minutes
Maximum Deviation From 0 on the Richmond Agitation Sedation Scale (RASS)
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
Time frame: 5,10,20,40,60,80,100,120 minutes
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.
| Milestone | Ketamine | Morphine |
|---|---|---|
| Started | 24 | 21 |
| Completed | 24 | 21 |
| Not completed | 0 | 0 |
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.
| NRS pain scale score | Ketamine | Morphine |
|---|---|---|
| Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score | -4.9 (-5.75 to -4) | -5 (-7.1 to -2.9) |
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
| minutes | Ketamine | Morphine |
|---|---|---|
| Time to Change in NRS Pain Score | 5 ± 2.63 | 5 ± 2.48 |
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.
| minutes | Ketamine | Morphine |
|---|---|---|
| Time to Maximal Change in NRS Pain Score | 5 ± 1.7 | 120 ± 22.2 |
Requiring more than two doses of the study medication provided for adequate pain control
| Percentage of patients | Ketamine | Morphine |
|---|---|---|
| Incidence of Treatment Failure | 25 | 14 |
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.
| Percentage of patients | Ketamine | Morphine |
|---|---|---|
| Incidence of Side Effects, Including Outlying Vital Signs | 58 | 57 |
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
| units on a scale | Ketamine | Morphine |
|---|---|---|
| Maximum Deviation From 0 on the Richmond Agitation Sedation Scale (RASS) | 0 (-3 to 3) | 0 (-2 to 1) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketamine | — | 0/24 (0%) | 0/24 (0%) |
| Morphine | — | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(Participants) | Ketamine | Morphine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 21 | 45 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Ketamine | Morphine | Total |
|---|---|---|---|
| Mean | 30.75 ± 11.87 | 29.29 ± 9.78 | 30.07 ± 10.84 |
| Sex: Female, Male(Participants) | Ketamine | Morphine | Total |
|---|---|---|---|
| Female | 10 | 12 | 22 |
| Male | 14 | 9 | 23 |
| Region of Enrollment(participants) | Ketamine | Morphine | Total |
|---|---|---|---|
| United States | 24 | 21 | 45 |
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Brooke Army Medical Center