Phase 4
Completed N=45
Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department
Abdomen, Acute · Other Acute Pain · Flank Pain · Back Pain
Source: ClinicalTrials.gov NCT01538745 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score — -4.9; -5 NRS pain scale score
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Change in Numerical Rating Scale (NRS) Pain Score From Baseline NRS Pain Score |
-4.9; -5 | — |
| SECONDARY Time to Change in NRS Pain Score |
5; 5 | — |
| SECONDARY Time to Maximal Change in NRS Pain Score |
5; 120 | — |
| SECONDARY Incidence of Treatment Failure |
25; 14 | — |
| SECONDARY Incidence of Side Effects, Including Outlying Vital Signs |
58; 57 | — |
| SECONDARY Maximum Deviation From 0 on the Richmond Agitation Sedation Scale (RASS) |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients age 18-59 who present to the Brooke Army Medical Center Emergency Department with acute (less than 10 days) abdominal pain, flank/lumbar back pain and or/pain to the extremities, and of sufficient severity in the judgement of the ED treating physician or PA to warrant use of intravenous opioids
Exclusion Criteria
- Poor vital sign stability hypoxia: Sats 180 heart rate: 120 respiratory rate: 30
- Altered mental status or intoxication
- Patient is unwilling to participate or provide informed consent
- History of chronic pain or pain syndrome with concurrent opioid medication use
- fibromyalgia
- Patient has received opioids and/or tramadol in the past 4 hours
- Prescription pain medication use (to exclude muscle relaxants, acetaminophen or NSAIDs including toradol) in the past 4 hours
- Allergy to morphine or ketamine
- Sole provider status
- Adverse reaction to morphine or ketamine in the past
- Patients, who in the opinion of the triage nurse, require immediate analgesic relief
- Patient is female of child-bearing age and unable to provide urine or serum for HCG analysis in triage
- Pregnancy or breast feeding
- Presence of oxygen dependent pulmonary disease, liver cirrhosis or Renal disease requiring dialysis. (as assessed by electronic chart review)
- Presence of Ischemic heart disease, heart failure or unstable dysrhythmias (as assessed by electronic chart review)
- Presence of intracranial mass or vascular lesion.
- Presence of psychosis or hallucinations
- Weight greater than 115kg or less than 45 kg
- History of acute ocular/head trauma
- History of increased intracranial pressure/hypertensive hydrocephalus
- Non-English speaking patients
Data sourced from ClinicalTrials.gov (NCT01538745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.