Multimodal mechanical stimulation reduces acute and chronic low back pain: Pilot data from a HEAL phase 1 study.

Background: Effective non-opioid pain management is of great clinical importance. The objective of this pilot study was to evaluate the effectiveness of multimodal mechanical stimulation therapy on low back pain. Methods: 11 female and 9 male patients aged 22-74 years (Mean 41.9 years, SD 11.04) receiving physical rehabilitation for acute (12) or chronic (8) low back pain chose heat (9) or ice (11) to accompany a 20-minute session of mechanical stimulation (M-Stim) therapy (Registered with Clinicaltrials.gov NCT04494841.) The M-Stim was delivered in 12 possible repeating "therapy cycle" patterns by three vibration motors (50 Hz, 100 Hz, 200 Hz) with amplitudes between 0.1-0.3 m/s2. Ten patients used a contained motor chassis attached to a thermoconductive single-curve metal plate. The next 10 patients' device had motors attached directly to a multidimensionally curved plate. Results: Mean pain on a 10 cm Visual Analog Scale (VAS) with the first motor/plate configuration went from 4.9 ± 2.3 cm to 2.5 ± 2.1 cm (57% decrease, p = 0.0112), while the second reduced pain from 4.8 ± 2.0 cm to 3.2 ± 1.9 cm (45%, p = 0.0353). Initial pain was greater with acute injury (5.8 ± 2.0 cm vs. 3.98 ± 1.8, p = 0.025) and for patients older than 40 (5.44 vs. 4.52), but pain reduction was proportional for chronic and younger patients. There was no significant difference between plate configurations. Conclusions: A Phase I clinical pilot investigation on a multi-motor multi-modal device was promising for drug free pain relief. Results suggested pain relief independent of thermal modality, patient age, or pain chronicity. Future research should investigate pain reduction over time for acute and chronic pain. Clinical Trial Registration: https://ClinicalTrials.gov, identifier: NCT04494841.

Rapid initiation of nasal saline irrigation to reduce severity in high-risk COVID+ outpatients.

OBJECTIVE: To determine whether initiating saline nasal irrigation after COVID-19 diagnosis reduces hospitalization and death in high-risk outpatients compared with observational controls, and if irrigant composition impacts severity. METHODS: Participants 55 and older were enrolled within 24 hours of a + PCR COVID-19 test between September 24 and December 21, 2020. Among 826 screened, 79 participants were enrolled and randomly assigned to add 2.5 mL povidone-iodine 10% or 2.5 mL sodium bicarbonate to 240 mL of isotonic nasal irrigation twice daily for 14 days. The primary outcome was hospitalization or death from COVID-19 within 28 days of enrollment by daily self-report confirmed with phone calls and hospital records, compared to the CDC Surveillance Dataset covering the same time. Secondary outcomes compared symptom resolution by irrigant additive. RESULTS: Seventy-nine high-risk participants were enrolled (mean [SD] age, 64 [8] years; 36 [46%] women; 71% Non-Hispanic White), with mean BMI 30.3. Analyzed by intention-to-treat, by day 28, COVID-19 symptoms resulted in one ED visit and no hospitalizations in 42 irrigating with alkalinization, one hospitalization of 37 in the povidone-iodine group, (1.27%) and no deaths. Of nearly three million CDC cases, 9.47% were known to be hospitalized, with an additional 1.5% mortality in those without hospitalization data. Age, sex, and percentage with pre-existing conditions did not significantly differ by exact binomial test from the CDC dataset, while reported race and hospitalization rate did. The total risk of hospitalization or death (11%) was 8.57 times that of enrolled nasal irrigation participants (SE = 2.74; P = .006). Sixty-two participants completed daily surveys (78%), averaging 1.8 irrigations/day. Eleven reported irrigation-related complaints and four discontinued use. Symptom resolution was more likely for those reporting twice daily irrigation (X2 = 8.728, P = .0031) regardless of additive. CONCLUSION: SARS-CoV-2+ participants initiating nasal irrigation were over 8 times less likely to be hospitalized than the national rate.

The number of injected same-day preschool vaccines relates to preadolescent needle fear and HPV uptake.

PURPOSE: Fear of needles develops at approximately five years of age, and decreases compliance with healthcare. We sought to examine the relationship of preschool vaccine history, parent and preadolescent needle fear, and subsequent compliance with optional vaccines. METHODS: As part of a private practice randomized controlled trial, parents and 10-12year olds rated needle anxiety on a 100mm visual analog scale. This follow-up cohort study compared their needle anxiety to previous vaccination records, including number of vaccinations between ages four and six years (total and same-day maximum), and subsequent initiation of the HPV vaccine through age 13. RESULTS: Of the 120 preadolescents enrolled between 4.28.09 and 1.19.2010, 117 received preschool vaccinations between ages four and six years. The likelihood of being in the upper quartile of fear (VAS≥83) five years later increased with each additional same-day injection (OR=3.108, p=0.0100 95%CI=1.311, 7.367), but was not related to total lifetime or total four-to-six year injections. Only 12.5% (15) of parents reported anxiety about their preadolescents' vaccines (VAS>50). Parent and child anxiety was weakly correlated (r=0.15). Eight children in the upper fear quartile began their HPV series (26.67%) compared to 14 in the lower quartile (48.28% VAS<32) (OR 2.57, p=0.0889, 95%CI 0.864-7.621); there was no difference in HPV uptake between upper and lower quartile of parent anxiety. CONCLUSIONS: The more same-day preschool injections between 4 and 6years of age, the more likely a child was to fear needles five years later. Preadolescent needle fear was a stronger predictor than parent vaccine anxiety of subsequent HPV vaccine uptake.

Imaging for Suspected Appendicitis: Variation Between Academic and Private Practice Models.

BACKGROUND: Little is known regarding the effect of different emergency department (ED) practice models on computed tomography (CT) and ultrasound (US) utilization for suspected appendicitis in the ED and through the potential inpatient hospital stay. OBJECTIVES: Examination rates of CT and US for suspected appendicitis at 2 different pediatric EDs (PEDs) through hospital admission: an academic affiliated tertiary PED (site A) compared with a private practice tertiary care PED (site B). METHODS: All visits with the ICD-9 (International Classification of Diseases, Ninth Revision) chief complaint of abdominal pain were retrospectively examined from May 1, 2009, to February 21, 2012. Suspected appendicitis visits were defined as any visit with the chief complaint of abdominal pain where a complete blood cell count was obtained. Abdominal CT and US in the PED and during hospital admission were compared across the 2 sites. Return visits within 72 hours were evaluated for any missed appendicitis. RESULTS: Overall appendicitis rates were similar at both sites: site A, 4.7%; site B, 4.0%. The odds of having a CT scan performed during visits to the PED for abdominal pain were significantly higher at site B (odds ratio [OR], 3.19; 95% confidence interval [95% CI], 2.74-3.71), whereas the odds of having an US at site B were the opposite (OR, 0.34; 95% CI, 0.28-0.40). When evaluating only the admitted visits, the odds of having a CT were also greater at site B (OR, 2.32; 95% CI, 1.86-2.94) and having an US were less (OR, 0.57; 95% CI, 0.44-0.73). CONCLUSIONS: In this study of 2 PEDs with differing practice models, we identified a dramatic difference in imaging utilization among patients with suspected appendicitis.

EMLA application exceeding two hours improves pediatric emergency department venipuncture success.

The purpose of this study was to determine whether placing Eutectic Mixture of Local Anesthetics (EMLA) at emergency department (ED) triage improves venipuncture success. Emergency department triage nurses prospectively identified patients aged 0-18 years assessed to have 50% or greater chance of needing venipuncture while in the emergency department. Identified patients received EMLA or no intervention according to randomized 24-h blocks. Data were collected on need for venipuncture, venipuncture success (defined as obtaining access in one attempt), and duration and success of EMLA application (defined as EMLA occluded between 1 and 5 h). Parents' satisfaction and perception of pain were assessed with a 5-item scale. Consent was obtained from 267 out of 287 patients, in whom 111 of 154 venipunctures were successful (72%). EMLA (n = 100) and no-intervention (n = 167) groups did not differ by age or dehydration-related illnesses. Nurses flagged patients more often on days when EMLA was not applied (χ(2) = 37.8, df2, p < 0.0001), but with lower specificity of needing venipuncture (48.5% no-intervention venipuncture rate vs. 73% venipuncture rate with EMLA (χ(2) = 14.4, df2, p = 0.0001). Of the 73 EMLA patients undergoing venipuncture, 2 removed EMLA at unknown times; 2 had application duration longer than 5 h, and nurses chose non-EMLA venipuncture sites for 8. Punctures through EMLA sites with appropriate duration were successful in 51/61 (84%) versus 58/89 (65%) in untreated skin (p = 0.01, odds ratio (OR) = 2.8; 95% confidence interval (CI) [1.3, 6.2]). Success in intention-to-treat groups did not differ (OR = 1.8, 95% CI [0.87, 3.7]). Improved venipuncture success was seen linearly with increased application duration (p = 0.018). Parents perceived less pain with punctures through EMLA sites (p = 0.006). Venipuncture through an EMLA site reduced pain and improved success. Rates improved with increasing application duration. Barriers to triage EMLA placement should be evaluated. Application longer than 2 h should be studied further as a means to improve success. EMLA was supplied as a part of the Investigator-sponsored study program of AstraZeneca.

An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department.

OBJECTIVE: A randomized controlled trial compared a reusable device combining cold and vibration to standard care for pediatric venous access pain relief. METHODS: Pediatric emergency department patients received either the cold vibration device placed 5 to 10 cm proximally throughout venipuncture or standard care control (primarily vapocoolant spray). Block randomization of patients with or without lidocaine cream already in place ensured equal allocation in both intervention groups. Pain was measured via self- and parent-report using the 0- to 10-point Faces Pain Scale-Revised and with coded videotaped observed behaviors. Venipuncture success, use of distraction, and access times were also assessed. RESULTS: Eighty-one 4- to 18-year-olds were randomized to the device (n = 41) or standard care (n = 40) (median age, 10.09 years; 95% confidence interval [95% CI], 8.91-10.89). Median patient-reported pain scores with the device were lower than with standard care (-2; 95% CI, -4 to 0), as were parent-assessed pain scores (-2; 95% CI, -4 to -2). Observed distress behaviors were more common with standard care (2; 95% CI, 1-3) than with the device (1; 95% CI, 0-2). Venipuncture success was more likely with the device (odds ratio, 3.05; 95% CI, 1.03-9.02). There were no device refusals. CONCLUSIONS: The combination of cold and vibration decreased venipuncture pain significantly more than standard care without compromising procedural success. A device incorporating these elements could overcome the common barriers to needle procedure pain control.

Development and validation of a pictorial nausea rating scale for children.

OBJECTIVE: The lack of a widely used, validated measure limits pediatric nausea management. The goal of this study was to create and validate a pictorial scale with regular incremental levels between scores depicting increasing nausea intensity. METHODS: A pictorial nausea scale of 0 to 10 with 6 faces (the Baxter Retching Faces [BARF] scale) was developed in 3 stages. The BARF scale was validated in emergency department patients with vomiting and in healthy patients undergoing day surgery procedures. Patients were presented with visual analog scales for nausea and pain, the pictorial Faces Pain Scale-Revised, and the BARF scale. Patients receiving opioid analgesics or antiemetic agents had their pain and nausea assessed before and 30 minutes after therapy. Spearman's ρ correlation coefficients were calculated. A Wilcoxon matched-pair rank test compared pain and nausea scores before and after antiemetic therapy. RESULTS: Thirty oncology patients and 15 nurses participated in the development of the scale, and 127 patients (52, emergency department; 75, day surgery) ages 7 to 18 years participated in the validation. The Spearman ρ correlation coefficient of the first paired BARF and visual analog scale for nausea scores was 0.93. Visual analog scales for nausea and BARF scores were significantly higher in patients requiring antiemetic agents (P = .0001) and decreased significantly after treatment (P = .0002), while posttreatment VAS (P = .20) and FPSR scores (P =.47) for patients receiving only antiemetic agents did not [corrected]. CONCLUSIONS: We describe the development of a pictorial scale with beginning evidence of construct validity for a self-report assessment of the severity of pediatric nausea. The scale had convergent and discriminant validity, along with an ability to detect change after treatment.

Emergency physician-administered propofol sedation: a report on 25,433 sedations from the pediatric sedation research consortium.

STUDY OBJECTIVE: We describe the adverse events observed in a large sample of children sedated with propofol by emergency physicians and identify patient and procedure characteristics predictive of more serious adverse events. METHODS: We identified sedations performed by emergency physicians using propofol as the primary sedative, included in the Pediatric Sedation Research Consortium database from July 2004 to September 2008. We describe the characteristics of the patients, procedures, location, adjunctive medications, and adverse events. We use a multivariable logistic regression model to identify predictors of more serious adverse events. RESULTS: Of 25,433 propofol sedations performed by emergency physicians, most (76%) were performed in a radiology department. More serious adverse events occurred in 581 sedations (2.28%; 95% confidence interval 2.1% to 2.5%). There were 2 instances of aspiration, 1 unplanned intubation, and 1 cardiac arrest. Significant predictors of serious adverse events were weight less than or equal to 5 kg, American Society of Anesthesiologists classification greater than 2, adjunctive medications (benzodiazepines, ketamine, opioids, or anticholinergics), nonpainful procedures, and primary diagnoses of upper respiratory illness or prematurity. CONCLUSION: We observed a low adverse event prevalence in this largest series of propofol sedations by emergency physicians. Factors indicating greater risk of more serious adverse events are detailed.

Effect of MRI strength and propofol sedation on pediatric core temperature change.

PURPOSE: To determine core body temperature variations in children undergoing MRI exams on 1.5 Tesla (T) and 3T magnetic field strengths and with and without propofol sedation. MATERIALS AND METHODS: Temporal artery temperatures were prospectively collected on 400 consecutive patients undergoing 1.5 Tesla (T) or 3.0T MRI scans. A cumulative logistic regression model was created using age, weight, MRI protocol, sedation status, pre-MRI temperature and MRI strength to assess risk of temperature change. RESULTS: For patients with complete pre- and post-MRI temperature data, mean temperatures did not significantly change (-0.0155°C, 95%CI, -0.035, 0.064; n = 385). Temperature changes differed significantly between propofol-sedated and nonsedated patients (-0.26°C ± .44 versus 0.24°C ± 0.42; P < 0.0001), as did temperature changes for patients on the 3T (0.076°C ± 0.52) versus 1.5T (-0.06°C ± 0.48; P = 0.011). Sedation status, age, MRI strength, and MRI protocol accounted for 44.17% of temperature variance. The temperatures of 15 patients' (3.9%) decreased >1°C; 12 were on the 1.5T. All 7 patients (1.8%) who increased >1°C were non-sedates. CONCLUSION: Clinically significant core body temperature change is uncommon in children undergoing MRI with different magnetic field strengths, and with and without propofol sedation.

Propofol vs pentobarbital for sedation of children undergoing magnetic resonance imaging: results from the Pediatric Sedation Research Consortium.

BACKGROUND: Pentobarbital and propofol are commonly used to sedate children undergoing magnetic resonance imaging (MRI). The Pediatric Sedation Research Consortium (PSRC) was created in 2003 to improve pediatric sedation process and outcomes. OBJECTIVE: To use PSRC records to compare the effectiveness, efficiency and adverse events of propofol vs pentobarbital for sedation of children undergoing MRI. METHODS: Pediatric Sedation Research Consortium records of children aged 6 months to 6 years who were primarily sedated with either i.v. pentobarbital or propofol were included. Participating PSRC investigators obtained institutional review board approval before data collection. RESULTS: Of 11 846 sedations for MRI, 7079 met inclusion criteria (propofol: n = 5072; pentobarbital: n = 2007). Demographic details were similar between the two groups. Ideal sedation was produced in 96.45% of the pentobarbital group and in 96.8% of the propofol group (P = 0.478), but pentobarbital was more likely to result in poor sedation cancelling the procedure (OR 5.88; CI 2.24, 15.40). Propofol resulted in physiologic changes more frequently than did pentobarbital (OR 5.69; CI 1.35, 23.97). Pentobarbital was associated with prolonged recovery (OR 16.82; CI 4.98, 56.8), unplanned admission (OR 5.60; CI 1.02, 30.82), vomiting (OR 36.76; CI 4.84, 279.2) and allergic complication (OR 9.15; CI 1.02, 82.34). The incidence of airway complications was not significantly different between the two. The median recovery time for patients receiving propofol was 30 min, whereas for pentobarbital it was 75 min (P < 0.001). CONCLUSION: Among institutions contributing data to the PSRC, it is found that propofol provides more efficient and effective sedation than pentobarbital for children undergoing MRI. Although apnea occurred with a greater frequency in patients who received propofol, the rate of apnea and airway complications for propofol was not statistically different from that seen in patients who received pentobarbital.

Hepatic enzyme decline after pediatric blunt trauma: a tool for timing child abuse?

OBJECTIVES: Previous research in adult patients with blunt hepatic injuries has suggested a pattern of serum hepatic transaminase concentration decline. Evaluating this decline after pediatric blunt hepatic trauma could establish parameters for estimating the time of inflicted injuries. Deviation from a consistent transaminase resolution pattern could indicate a developing complication. METHODS: Retrospective review of pediatric patients with injuries including blunt liver trauma admitted to one of four urban level 1 trauma centers from 1990 to 2000. Cases were excluded for shock, death within 48 h, complications, or inability to determine injury time. Transaminase concentration decline was modeled by individual patients, by injury grade, and as a ratio with regard to injury time. RESULTS: One hundred and seventy-six patients met inclusion criteria. The rate of aspartate aminotransferase (AST) clearance changed significantly over time. Alanine aminotransferase (ALT) fell more slowly. Of the 118 patients who had multiple measurements of AST, for 112 (95%) the first concentration obtained was the highest. When ALT was greater than AST, the injury was older than 12h (97% specificity (95% CI, 95-99%), sensitivity 42% (95% CI, 33-50%)). Patients with enzymes that rose after 14 h post-injury were more likely to develop complications (RR=24, 95% CI 10-58). CONCLUSIONS: Hepatic transaminases rise rapidly after uncomplicated blunt liver injury, then fall predictably. Persistently stable or increasing concentrations may indicate complications. ALT>AST indicates subacute injury.

Vaso-occlusive episodes in older children with sickle cell disease: emergency department management and pain assessment.

OBJECTIVE: To describe emergency department (ED) management of older children with sickle cell disease (SCD) experiencing a vaso-occlusive episode (VOE) and factors associated with disposition and ED return. STUDY DESIGN: We retrospectively reviewed ED visits of children age >/=8 years with SCD over the course of 1 year. Data were collected from the electronic medical record and the SCD database. RESULTS: VOE was diagnosed 279 times in 105 patients; 45 of the patients had 1 ED visit, 25 had 2 ED visits, and 16 had >/=5 ED visits. The overall admission rate was 178/279 (64%), 166 on the first ED visit and 12 on a return visit within 72 hours. Use of home opioids, duration of VOE, and hemoglobin concentration were not associated with disposition. Discharge after 2 doses of intravenous (IV) morphine occurred in 33 patients. Pain relief after 1 dose, using a FACES scale of 1 to 5, differed significantly between the admitted patients and the discharged patients (1.1 vs 2.5; P < .0001). CONCLUSION: Suboptimal pain relief after 1 dose of IV morphine was associated with admission from the ED. Further investigation of pain relief, using validated pain assessment scales, as an outcome in VOE management is warranted.

Local anesthetic and stylet styles: factors associated with resident lumbar puncture success.

OBJECTIVE: To assess the effects of procedural techniques, local anesthetic use, and postgraduate training level on lumbar puncture (LP) success rates. METHODS: In this prospective observational study, medical students and residents ("trainees") reported techniques used for infant LPs in an urban teaching emergency department. Data on postgraduate year, patient position, draping, total and trainee numbers of attempts, local anesthetic use, and timing of stylet removal were collected. Logistic regression analysis was used to identify predictors of successful LP, with success defined as the trainee obtaining cerebrospinal fluid with <1000 red blood cells per mm3. RESULTS: We collected data on 428 (72%) of 594 infant LPs performed during the study period. Of 377 performed by trainees, 279 (74%) were successful. Local anesthesia was used for 280 (74%), and 225 (60%) were performed with early stylet removal. Controlling for the total number of attempts, LPs were 3 times more likely to be successful among infants >12 weeks of age than among younger infants (odds ratio [OR]: 3.1; 95% confidence interval [CI]: 1.2-8.5). Controlling for attempts and age, LPs performed with local anesthetic were twice as likely to be successful (OR: 2.2; 95% CI: 1.04-4.6). For infants < or =12 weeks of age, early stylet removal improved success rates (OR: 2.4; 95% CI: 1.1-5.2). Position, drape use, and year of training were not significant predictors of success. CONCLUSIONS: Patient age, use of local anesthetic, and trainee stylet techniques were associated with LP success rates. This offers an additional rationale for pain control. Predictors identified in this study should be considered in the training of physicians, to maximize their success with this important procedure.

Pain, position, and stylet styles: infant lumbar puncture practices of pediatric emergency attending physicians.

OBJECTIVES: Lumbar punctures (LPs) are common emergency department (ED) procedures. Few pediatric studies exist to define training, guide practice, or indicate preferred methods for infants. While pain control is recommended, no recent studies indicate prevalence of analgesic use since the advent of topical anesthetics. We surveyed academic pediatric ED physicians to assess training and technique preferences and to highlight pain control usage. METHODS: A total of 398 physicians were randomly selected from the 621 e-mail accessible members of the AAP Section on Pediatric Emergency Medicine. Questions concerning physician training, analgesia, and technique were either sent by regular mail or via e-mail link to a Web-based survey. RESULTS: Of 359 deliverable surveys, there were 188 physician responses (52.4%) with differential response rates by survey format [58 e-mail (36%) and 130 regular mail responses (66%); P < 0.05]. Almost a third will advance the needle without the stylet in place. Two-thirds of physicians do not routinely use analgesia for neonatal LPs. Those using pain control were trained more recently (median 12 years vs. 15 years postresidency; P = 0.04). Analgesia use was the most common practice changed since residency. CONCLUSIONS: Analgesia is underused for infant LPs. Advancing the needle without a stylet is not uncommon. Response rate to regular mail surveys was much higher.

Accidental scald burns in sinks.

Scald burns to the feet and lower extremities in children are described in the literature as often resulting from forced immersions. This report illustrates 3 cases of burns whose distribution and historical factors identify them as accidental. The location of these accidental burns is similar to those found in inflicted injury, but the patterns were indicative of flowing water burns, not forced immersions. Burns in these locations may be confused with abuse. Medical providers need to be aware of information that may enable them to distinguish the 2 causes. Effective caregiver education regarding the importance of lowering the temperature of water heaters and discouraging play in household sinks is critical to prevent additional tap water scald burn injuries.