Back Pain Clinical Trial
Official title:
Low Dose Ketamine (LDK) Versus Morphine for Acute Pain Control in the Emergency Department
NCT number | NCT01538745 |
Other study ID # | C.2011.173 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | February 2012 |
Est. completion date | June 2013 |
Verified date | February 2021 |
Source | Brooke Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | June 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 59 Years |
Eligibility | 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<95% hypotension: SBP<90 hypertension: SBP>180 heart rate: <50 or >120 respiratory rate: <10 or >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 |
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center | U.S. Air Force Office of the Surgeon General |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 5,10,20,40,60,80,100,120 minutes post dose | |
Secondary | 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 | 5,10, 20,40,60,80,100,120 minutes | |
Secondary | 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. | 5, 10, 20 minutes and then every 20 minutes to a total of 120 minutes | |
Secondary | Incidence of Treatment Failure | Requiring more than two doses of the study medication provided for adequate pain control | 120 minutes | |
Secondary | 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. | 5,10,20,40,60,80,100,120 minutes | |
Secondary | 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 |
5,10,20,40,60,80,100,120 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05982483 -
Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain
|
N/A | |
Completed |
NCT04744246 -
Muscle Activity During Load Carriage in ROTC Cadets
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Active, not recruiting |
NCT03680846 -
Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain
|
N/A | |
Completed |
NCT05597189 -
Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain
|
N/A | |
Completed |
NCT05342181 -
Static and Dynamic Core Stability Exercises in Potpartum Back Pain
|
N/A | |
Completed |
NCT02955342 -
Back and Neck Pain in Adolescence
|
||
Not yet recruiting |
NCT02536274 -
"Examination of the Impact of a Dynamic Flexion Orthosis (Dynaflex®Ottobock) or of a Back Bandage (Lumbo Sensa®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Back Pain"
|
N/A | |
Completed |
NCT02704845 -
Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain
|
N/A | |
Recruiting |
NCT02237105 -
The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery
|
N/A | |
Enrolling by invitation |
NCT02485795 -
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
|
N/A | |
Completed |
NCT02254694 -
The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body
|
N/A | |
Completed |
NCT02609009 -
Back Pain and Spinal Manipulation in Adolescent Scoliosis
|
N/A | |
Terminated |
NCT02239627 -
Epidural Clonidine Versus Corticosteroid for Low Back Pain
|
N/A | |
Completed |
NCT00986180 -
NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
|
Phase 3 | |
Completed |
NCT00771758 -
Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis
|
Phase 3 | |
Terminated |
NCT00769626 -
Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy
|
Phase 3 | |
Withdrawn |
NCT00231374 -
Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning
|
N/A | |
Completed |
NCT00103675 -
Sensor Measurement of Acupuncture Needle Manipulation
|
Phase 1 | |
Completed |
NCT00454064 -
Cognitive-behavioural Treatment of Chronic Back Pain
|
Phase 3 |