Comparison of Nebulized Ketamine to Intravenous Subdissociative Dose Ketamine for Treating Acute Painful Conditions in the Emergency Department: A Prospective, Randomized, Double-Blind, Double-Dummy Controlled Trial.

STUDY OBJECTIVE: We aimed to assess and compare the analgesic efficacy and adverse effects of intravenous subdissociative-dose ketamine to nebulized ketamine in emergency department (ED) patients with acute painful conditions. METHODS: We conducted a prospective, randomized, double-blind, double-dummy clinical trial in adult patients (ages 18 and older) with a numerical rating scale pain score of ≥5. We randomized subjects to receive either a single dose of 0.3 mg/kg of intravenous (IV) ketamine or 0.75 mg/kg of nebulized ketamine through a breath-actuated nebulizer. Primary outcome was the difference in pain scores on the numerical rating scale between groups at 30 minutes postmedication administration. The secondary outcomes included the need for rescue analgesia, occurrences of adverse events in each group, and the difference in pain scores at 15, 30, 60, 90, and 120 minutes. We calculated a 95% confidence interval (CI) for a mean difference at 30 minutes, with a minimum clinically important difference set at 1.3 points. RESULTS: We enrolled 150 subjects (75 per group). Mean pain scores through numerical rating scale were 8.2 for both groups at baseline, which decreased to 3.6 and 3.8 at 30 minutes, yielding a mean difference of 0.23 (95% CI -1.32 to 0.857). We observed no clinically concerning changes in vital signs. No serious adverse events occurred in any of the groups throughout the study period. CONCLUSION: We found no difference between the administration of IV and nebulized ketamine for the short-term treatment of moderate to severe acute pain in the ED, with both treatments providing a clinically meaningful reduction in pain scores at 30 minutes.

Complementary and Alternative Medicine Use in Patients With Cancer and Immigration Background.

PURPOSE: Studies have shown that patients with cancer are more likely to use complementary and alternative medicine (CAM) than noncancer patients for symptom relief and hope. We aimed to evaluate factors of race, ethnic groups, and immigration status in attitude of patients with cancer in seeking out CAM. PATIENTS AND METHODS: This is a prospective questionnaire study where information on demographics, cancer information, race/ethnicity, immigration duration, and psychosocial factors was correlated with the CAM use in a community cancer center located in the borough of Brooklyn, at New York City. RESULTS: Among 658 patients, the prevalence of CAM use was 66.11%. CAM use was 71.98% in females and 54.34% in males (P = .113 × 10-4). Patients of African descent had higher CAM use (72.73%) than the White patients (63.53%; P = .0371). There was no difference of CAM use between the US born (68.77%) and the immigrants (63.98%, P = .199) as a whole; however, comparing with the US born (66.50%), Asian-born immigrants had lower CAM use (53.77%, P = .0161), whereas Latin-American born had a numerical trend toward higher CAM use (74.83%, P = .0608). The number of years of living in the United States was not associated with more CAM use. Prayer and spirituality was the most common CAM subtype used (25.91%). There was no difference in CAM use in the respective non-White ethnic groups whether they were US born or non-US born. CONCLUSION: In this cohort of patients with cancer enriched with immigration background, CAM use was the highest in African American patients. The use of CAM in the non-White patients was associated with their ethnic background, regardless whether they were US born or not. Cultural roots appeared to be a strong influencing factor for the usage of CAM.

Oral Aspirin/ketamine versus oral ketamine for emergency department patients with acute musculoskeletal pain.

OBJECTIVE: The purpose of this study is to investigate if an orally administered combination of aspirin and ketamine will provide better analgesia than a ketamine alone in adult patients presenting to the Emergency Department (ED) with acute musculoskeletal pain. METHODS: We conducted a prospective, randomized, open-label trial of ED patients aged 18 and older presenting with moderate to severe acute musculoskeletal pain as defined by an 11-point numeric rating scale (NRS) with an initial score of ≥5. Patients were randomized to receive either 324 mg of VTS-Aspirin™ and 0.5 mg/kg of oral ketamine (AOK) that is directly swallowed or 0.5 mg/kg of oral ketamine (OK) alone that is swished first and then swallowed. Patients were assessed at baseline, 30, 60, 90, and 120 min. The primary outcome was a difference in pain scores between the two groups at 60 min post-administration. Secondary outcomes included adverse events and the need for rescue analgesia. RESULTS: We enrolled 60 patients in the study (30 per group). The difference in mean pain scores at 60 min between the AOK and OK groups was 2.6 [95% CI: 1.38-3.77] showing a lower mean pain score in the OK group. At 60 min, the AOK group had a change in mean pain score from 8.4 to 6.3 (difference 2.1; 95% CI: 1.35-3.00). The OK group had a change in mean pain score from 7.8 to 3.7 (difference 4.1, 95% CI: 3.25-4.90). No clinically concerning changes in vital signs were observed. No serious adverse events occurred in either group. The most commonly reported adverse effects were dizziness and fatigue. None of the participants required rescue analgesia at 60 min post-medications administration. CONCLUSION: The administration of an oral combination of VTS-Aspirin ™ and ketamine resulted in less analgesia compared to oral ketamine alone, for the short-term treatment of moderate to severe acute musculoskeletal pain in the ED. CLINICALTRIALS: govRegistration: NCT04860804.

Analgesic Efficacy of Oral Aspirin/Ketamine Combination for Management of Acute Musculoskeletal Pain in the Emergency Department - A Proof of Concept Pilot Study.

BACKGROUND: Musculoskeletal pain (MSK) affects one out of three adults and is the most common source of significant long-term pain, physical disability, and under-treatment in the emergency department (ED). OBJECTIVE: We aimed to assess the analgesic efficacy of a combination of oral VTS-Aspirin® (Vitalis Analgesics, New York, NY) and ketamine in managing acute MSK pain in adult ED patients. METHODS: This was a prospective, proof-of-concept, single-arm, pilot study evaluating the analgesic efficacy of a single dose of oral combination of VTS-Aspirin and ketamine in adult ED patients with acute moderate-to-severe MSK pain. The primary outcome included the difference in pain scores on an 11-point numeric pain rating scale at 60 min. Secondary outcomes included the need for rescue analgesia, the occurrence of adverse events at 60 min, and a change in pain scores at 120 min. RESULTS: We enrolled 25 subjects in the study. The mean baseline pain score was 8.6 and the mean pain score at 60 min decreased to 4.8. The oral ketamine dose ranged from 24 mg to 50 mg, with a mean dose of 37.8 mg. No clinically concerning changes in vital signs were noted. No serious adverse events occurred in any of the subjects. Majority of adverse effects were transient and weak in intensity. CONCLUSION: We demonstrated that administration of an oral combination of VTS-Aspirin and ketamine to adult ED patients with acute MSK pain resulted in clinically significant pain relief in 80% of enrolled subjects.

Paraphimosis Pain Treatment with Nebulized Ketamine in the Emergency Department.

BACKGROUND: Paraphimosis is an acute urological emergency occurring in uncircumcised males that can lead to strangulation of the glans and painful vascular compromise. Ketamine has been used in the emergency department (ED) as an anesthetic agent for procedural sedation, and when administrated in a sub-dissociative dose (low dose) at 0.1-0.3 mg/kg, ketamine has been utilized in the ED and prehospital settings for pain control as an adjunct and as an alternative to opioid, as well as for preprocedural sedation. This report details the case of a pediatric patient who presented to our Pediatric ED with paraphimosis and had his procedural pain treated with ketamine administrated via a breath-actuated nebulizer (BAN). CASE REPORT: This case report illustrates the potential use of ketamine via BAN to effectively achieve minimal sedation for a procedure in pediatric patients in the ED. The patient was a 15-year-old boy admitted to the Pediatric ED complaining of groin pain due to paraphimosis. The patient was given 0.75 mg/kg of nebulized ketamine via BAN, and 15 min after the medication administration the pain score was reduced from 5 to 1 on the numeric pain rating scale. The patient underwent a successful paraphimosis reduction without additional analgesic or sedative agents 20 min after the administration of nebulized ketamine. The patient was subsequently discharged home after 60 min of monitoring, with a pain score of 0. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: The use of nebulized ketamine via BAN might represent a viable, noninvasive way to provide a mild sedative and be an effective analgesic option for managing a variety of acute painful conditions and procedures in the pediatric ED.

Take-Pause: Efficacy of mindfulness-based virtual reality as an intervention in the pediatric emergency department.

BACKGROUND: Emergency department (ED) visits are known to be anxiety-ridden and stress-provoking experiences especially in the pediatric population. Distraction techniques have been used as a means to reduce anxiety and stress thereby facilitating care in the ED and making the visit less unpleasant. Our study aimed to evaluate the effectiveness of an active and immersive distraction technique, using a mindfulness-based virtual reality (VR) program (Take-Pause), to alleviate anxiety in pediatric ED patients. METHODS: A prospective, randomized, single-blinded study, evaluating ED patients aged 13-17 years with a chief complaint of acute pain was conducted. Patients were randomized either to the active distraction intervention (VR group), utilizing the VR headset for 5 min, or to the passive distraction intervention (iPad group), playing on an iPad for 5 min. The primary outcome was a difference in the change in anxiety scores on the Spielberger State-Trait Anxiety Inventory between the two groups. Secondary outcomes included a difference in pain scores, respiratory rate, and heart rate between the groups. RESULTS: A total of 110 subjects were enrolled. At 15 min, the mean anxiety score for the VR group improved by 10 points versus 6 points in the iPad group (p < 0.001; 95% confidence interval = 0.44 to 7.6). There was no statistical significance in the reduction of pain scores (p = 0.953) and respiratory rates (p = 0.776) between the groups. Patients enrolled in both groups did not experience any adverse effects. CONCLUSION: Take-Pause, offering an active and immersive distraction technique, is more effective than a passive distraction approach to lower anxiety levels in adolescent ED patients.

Comparison of Nebulized Ketamine at Three Different Dosing Regimens for Treating Painful Conditions in the Emergency Department: A Prospective, Randomized, Double-Blind Clinical Trial.

STUDY OBJECTIVE: We aimed to assess and compare the analgesic efficacies and adverse effects of ketamine administered through a breath-actuated nebulizer at 3 different dosing regimens for emergency department patients presenting with acute and chronic painful conditions. METHODS: This was a prospective, randomized, double-blinded trial comparing 3 doses of nebulized ketamine (0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg) administered through breath-actuated nebulizer in adult emergency department patients aged 18 years and older with moderate to severe acute and chronic pain. The primary outcome included the difference in pain scores on an 11-point numeric rating scale between all 3 groups at 30 minutes. Secondary outcomes included the need for rescue analgesia (additional doses of nebulized ketamine or intravenous morphine) and adverse events in each group at 30 and 60 minutes. RESULTS: We enrolled 120 subjects (40 per group). The difference in mean pain scores at 30 minutes between the 0.75 mg/kg and 1 mg/kg groups was 0.25 (95% confidence interval [CI] 1.28 to 1.78); between the 1 mg/kg and 1.5 mg/kg groups was -0.225 (95% CI -1.76 to 1.31); and between the 0.75 mg/kg and 1.5 mg/kg groups was 0.025 (95% CI -1.51 to 1.56). No clinically concerning changes in vital signs occurred. No serious adverse events occurred in any of the groups. CONCLUSION: We found no difference between all 3 doses of ketamine administered through breath-actuated nebulizer for short-term treatment of moderate to severe pain in the emergency department.

Diagnostic Accuracy of Point-Of-Care Ultrasound for Intussusception Performed by Pediatric Emergency Medicine Physicians.

BACKGROUND: Intussusception (INT) is a common cause of bowel obstruction in young children. Delay in diagnosis can lead to significant morbidity and mortality. There have been several studies evaluating early point-of-care ultrasound (POCUS) in the diagnosis of INT by nonradiologists. OBJECTIVE: Our objective was to determine the diagnostic accuracy of POCUS by novice sonographer pediatric emergency medicine physicians (PEM-Ps) who received focused US training for diagnosing INT. METHODS: We performed a prospective observational study including 17 PEM-Ps (14 attendings, 3 fellows) trained to perform abdominal US for INT. Children suspected of having INT received POCUS performed and interpreted by a PEM-P, followed by a US study performed by a certified ultrasonographer and interpreted by an attending pediatric radiologist. Diagnostic concordance between PEM-P-and radiology-performed US (RPUS) results was assessed. RESULTS: One hundred patients were enrolled; median patient age was 24 months. There was excellent diagnostic agreement for presence or absence of INT between PEM-Ps and RPUS (97% of cases; κ = 0.826). POCUS-diagnosed INT was present in 8 of 9 patients with RPUS-diagnosed INT (sensitivity 89%; 95% confidence interval [CI] 51-99%; specificity 98%; 95% CI 92-100%; positive predictive value 80%; 95% CI 44-96%; negative predictive value 99%; 95% CI 93-100%). Likelihood ratio for INT with a positive POCUS was 40.44 (95% CI 10.07-162.36) and with a negative POCUS was 0.11 (95% CI 0.02-0.72). CONCLUSIONS: POCUS performed by novice sonographers to diagnose INT has high diagnostic concordance with RPUS. Emergency department-performed POCUS is a rapid and accurate method for diagnosing INT.

Comparison of Oral Ibuprofen and Acetaminophen with Either Analgesic Alone for Pediatric Emergency Department Patients with Acute Pain.

BACKGROUND: Ibuprofen (Motrin; Johnson & Johnson) and acetaminophen (APAP, paracetamol) are the most commonly used analgesics in the pediatric emergency department (ED) for managing a variety of acute traumatic and nontraumatic painful conditions. The multimodal pain management of using a combination of ibuprofen plus acetaminophen has the potential to result in greater analgesia. OBJECTIVE: We compared the analgesic efficacy of a combination of oral ibuprofen plus acetaminophen with either analgesic alone for pediatric ED patients with acute pain. METHODS: We performed a randomized, double-blind superiority trial assessing and comparing the analgesic efficacy of a combination of oral ibuprofen (10 mg/kg dose) plus acetaminophen (15 mg/kg per dose) to either analgesic alone for the treatment of acute traumatic and nontraumatic pain in the pediatric ED. Primary outcomes included a difference in pain scores among the three groups at 60 min. RESULTS: We enrolled 90 patients (30 per group). The difference in mean pain scores at 60 min between acetaminophen and combination groups was 0.30 (95% confidence interval [CI] -0.84 to 1.83); between ibuprofen and combination groups was -0.33 (95% CI -1.47 to 0.80); and between acetaminophen and ibuprofen groups was 0.63 (95% CI -0.54 to 1.81). Reductions in pain scores from baseline to 60 min were similar for all patients in each of the three groups. No adverse events occurred in any group. CONCLUSIONS: We found similar analgesic efficacy of oral ibuprofen and acetaminophen in comparison with each analgesic alone for short-term treatment of acute pain in the pediatric ED, but the trial was underpowered to demonstrate the analgesic superiority of the combination of oral ibuprofen plus acetaminophen in comparison with each analgesic alone.

Administration of Nebulized Ketamine for Managing Acute Pain in the Emergency Department: A Case Series.

Ketamine administration in sub-dissociative doses in the emergency department (ED) results in effective pain relief in patients with acute traumatic and non-traumatic pain, chronic pain, and opioid-tolerant pain. This case series describes five adult ED patients who received nebulized ketamine for predominantly acute traumatic pain. Three patients received nebulized ketamine at 1.5 milligrams per kilogram (mg/kg) dose, one patient at 0.75 mg/kg, and one patient at 1 mg/kg. All five patients experienced a decrease in pain from the baseline up to 120 minutes. The inhalation route of ketamine delivery via breath-actuated nebulizer may have utility for managing pain in the ED.

Comparison of intravenous lidocaine/ketorolac combination to either analgesic alone for suspected renal colic pain in the ED.

STUDY OBJECTIVE: To compare analgesic efficacy and safety of intravenous lidocaine and ketorolac combination to each analgesic alone for ED patients with suspected renal colic. METHODS: We conducted a randomized, double-blind trial comparing analgesic efficacy of a combination of intravenous lidocaine (1.5 mg/kg) and ketorolac (30 mg), to ketorolac (30 mg), and to lidocaine (1.5 mg/kg) in patients aged 18-64 presenting to the ED with suspected renal colic. Primary outcome included difference in pain scores between the groups at 30 min. Secondary outcomes included a comparative reduction in pain scores in each group from baseline to 30 and 60 min as well as rates of adverse events and need for rescue analgesia at 30 and 60 min. RESULTS: We enrolled 150 subjects (50 per group). The difference in mean pain scores at 30 min between Lidocaine and Lidocaine/Ketorolac groups was -2.89 (95% CI: -4.39 to -1.39); between Ketorolac and Lidocaine/Ketorolac group was -0.92 (95% CI: -2.44 to 0.61); and between Ketorolac and Lidocaine was -1.98 (95% CI: -3.69 to -0.27). A comparative percentage of subjects in each group required rescue analgesia at 30 and 60 min. No clinically concerning changes in vital signs were observed. No serious adverse events occurred in either group. Commonly reported adverse effects were dizziness, nausea, and headache. CONCLUSION: The administration of intravenous lidocaine/ketorolac combination to ED patients with suspected renal colic results in better analgesia in comparison to lidocaine alone but provides no analgesic advantages over ketorolac alone. Clinicaltrials.gov Registration: NCT02902770.

Comparison of Oral Ibuprofen at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial.

STUDY OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) are used extensively for the management of acute pain, with ibuprofen being one of the most frequently used oral analgesics in the emergency department (ED). We compare the analgesic efficacy of oral ibuprofen at 3 different doses for adult ED patients with acute pain. METHODS: This was a randomized, double-blind trial comparing analgesic efficacy of 3 doses of oral ibuprofen (400, 600, and 800 mg) in adult ED patients with acute painful conditions. Primary outcome included difference in pain scores between the 3 groups at 60 minutes. RESULTS: We enrolled 225 subjects (75 per group). The difference in mean pain scores at 60 minutes between the 400- and 600-mg groups was -0.14 (95% confidence interval [CI] -0.67 to 0.39); between the 400- and 800-mg groups, 0.14 (95% CI -0.65 to 0.37); and between the 600- and 800-mg groups, 0.00 (95% CI -0.47 to 0.47). Reductions in pain scores from baseline to 60 minutes were similar for all subjects in each of the 3 groups. No adverse events occurred in any group. CONCLUSION: Oral ibuprofen administered at doses of 400, 600, and 800 mg has similar analgesic efficacy for short-term pain relief in adult patients presenting to the ED with acute pain.

Comparison of Intravenous Ketorolac at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial.

STUDY OBJECTIVE: Nonsteroidal anti-inflammatory drugs are used extensively for the management of acute and chronic pain, with ketorolac tromethamine being one of the most frequently used parenteral analgesics in the emergency department (ED). The drugs may commonly be used at doses above their analgesic ceiling, offering no incremental analgesic advantage while potentially adding risk of harm. We evaluate the analgesic efficacy of 3 doses of intravenous ketorolac in ED patients with acute pain. METHODS: We conducted a randomized, double-blind trial to assess the analgesic efficacy of 3 doses of intravenous ketorolac (10, 15, and 30 mg) in patients aged 18 to 65 years and presenting to the ED with moderate to severe acute pain, defined by a numeric rating scale score greater than or equal to 5. We excluded patients with peptic ulcer disease, gastrointestinal hemorrhage, renal or hepatic insufficiency, allergies to nonsteroidal anti-inflammatory drugs, pregnancy or breastfeeding, systolic blood pressure less than 90 or greater than 180 mm Hg, and pulse rate less than 50 or greater than 150 beats/min. Primary outcome was pain reduction at 30 minutes. We recorded pain scores at baseline and up to 120 minutes. Intravenous morphine 0.1 mg/kg was administered as a rescue analgesic if subjects still desired additional pain medication at 30 minutes after the study drug was administered. Data analyses included mixed-model regression and ANOVA. RESULTS: We enrolled 240 subjects (80 in each dose group). At 30 minutes, substantial pain reduction was demonstrated without any differences between the groups (95% confidence intervals 4.5 to 5.7 for the 10-mg group, 4.5 to 5.6 for the 15-mg group, and 4.2 to 5.4 for the 30-mg group). The mean numeric rating scale pain scores at baseline were 7.7, 7.5, and 7.8 and improved to 5.1, 5.0, and 4.8, respectively, at 30 minutes. Rates of rescue analgesia were similar, and there were no serious adverse events. Secondary outcomes showed similar rates of adverse effects per group, of which the most common were dizziness, nausea, and headache. CONCLUSION: Ketorolac has similar analgesic efficacy at intravenous doses of 10, 15, and 30 mg, showing that intravenous ketorolac administered at the analgesic ceiling dose (10 mg) provided effective pain relief to ED patients with moderate to severe pain without increased adverse effects.

Development of an opioid reduction protocol in an emergency department.

PURPOSE: Results of a study of an opioid-sparing protocol for acute pain management in the emergency department (ED) are reported. METHODS: The ED of a large hospital conducted a project, the "Opioid-Free Shift," to test a multimodal pharmacologic approach to analgesic therapy as an alternative to routine use of opioids. During a specified eight-hour period, all adults arriving at the ED with a complaint of pain were treated according to an opioid-sparing protocol based on principles of channel enzyme receptor-targeted analgesia (CERTA). Pain severity was assessed at baseline and at 30 and 60 minutes after analgesia administration using a validated rating scale. RESULTS: Seventeen patients were treated in the ED for acute or chronic pain during the study period. The median pain score on the 11-point rating scale was 8 (range, 4-10) at baseline, declining to 6 (range, 0-10) at 30 minutes and to 5 (range, 1-10) at 60 minutes. At 30 minutes, 7 patients (41%) had a pain score reduction of ≥ 30% and 3 (18%) had a reduction of ≥ 50%. Six of the 15 patients (40%) reassessed at 60 minutes had a pain score reduction of ≥ 30%; 4 patients (27%) had a reduction of ≥ 50%. More than 80% of patients were satisfied with the pain relief provided through the CERTA-based protocol, and no adverse drug reactions were reported. CONCLUSION: The 17 patients treated for acute or chronic pain during the opioid-free shift were managed mainly with i.v. ketorolac and oral ibuprofen, with only 1 patient requiring rescue opioid therapy.