Pediatrics – Critical Care & Emergencies
News Release – FDA Approves First Nasal Spray for Anaphylaxis Treatment: Neffy (Epinephrine Nasal Spray) – U.S. Food and Drug Administration
17 Aug, 2024 | 15:43h | UTCThe U.S. Food and Drug Administration (FDA) has approved Neffy, the first epinephrine nasal spray for the emergency treatment of anaphylaxis and other severe allergic reactions (Type I) in both adults and pediatric patients weighing at least 30 kilograms (approximately 66 pounds). This approval introduces a non-injectable option for the rapid administration of epinephrine, which is critical in managing life-threatening allergic reactions.
Key Points for Healthcare Providers:
– Alternative to Injection: Neffy provides a new option for patients who may delay or avoid epinephrine injections due to needle phobia. This could be particularly beneficial for children and others reluctant to use injectable epinephrine.
– Efficacy and Safety: Neffy’s approval is supported by studies comparing its pharmacokinetics and pharmacodynamics to traditional epinephrine injections. These studies showed comparable blood epinephrine levels and similar physiological effects, such as increased blood pressure and heart rate.
– Administration: Neffy is a single-dose nasal spray, administered into one nostril. If symptoms do not improve or worsen, a second dose may be administered in the same nostril. Patients should still seek emergency medical care to monitor the anaphylactic reaction.
– Warnings: Certain nasal conditions, such as nasal polyps or a history of nasal surgery, may impair Neffy’s absorption. In these cases, injectable epinephrine might be a more reliable option. The product also carries typical warnings for epinephrine use, particularly in patients with coexisting conditions.
– Side Effects: Common side effects include throat irritation, nasal discomfort, headaches, and jitteriness. Healthcare professionals should discuss these with patients to ensure informed use.
Clinical Implications:
Neffy may reduce barriers to the timely treatment of anaphylaxis, potentially improving outcomes by increasing the likelihood of rapid epinephrine administration. Healthcare providers should consider Neffy as an alternative for patients who are needle-averse or have difficulty using injectable epinephrine, while also ensuring patients understand the importance of prompt medical attention following its use.
Approval Background:
Neffy was granted Fast Track designation by the FDA, emphasizing the need for an alternative to injectable epinephrine. The approval was awarded to ARS Pharmaceuticals.
Source: FDA News Release: FDA Approves First Nasal Spray for Treatment of Anaphylaxis
Meta-Analysis: Daily Sedation Interruption Shortens PICU Stay Without Impacting Mortality or Ventilation Duration in Pediatric MV Patients – JAMA Netw Open
11 Aug, 2024 | 13:19h | UTCStudy Design and Population: This systematic review and meta-analysis included six randomized clinical trials (RCTs) involving 2,810 pediatric patients receiving mechanical ventilation (MV) in the pediatric intensive care unit (PICU). The trials compared the effects of daily sedation interruption (DSI) with continuous intravenous (IV) sedation on clinical outcomes such as MV duration and PICU length of stay.
Main Findings: The analysis found that DSI was associated with a significant reduction in the length of PICU stay (mean difference of -1.45 days, p = 0.03). However, there was no significant difference in the duration of MV between DSI and continuous sedation (mean difference of -0.93 days, p = 0.06). Additionally, there were no significant differences in total sedative doses, adverse events, or mortality between the two groups.
Implications for Practice: The findings suggest that DSI may reduce the length of PICU stay without increasing the risk of adverse events, making it a potentially valuable strategy in managing sedation for pediatric patients on MV. However, further research is needed to explore the long-term neurodevelopmental outcomes associated with DSI.
RCT: Video laryngoscopy improves first-attempt intubation success in neonates compared to direct laryngoscopy – N Engl J Med
11 May, 2024 | 13:37h | UTCStudy Design and Population: This single-center randomized clinical trial investigated the efficacy of video laryngoscopy versus direct laryngoscopy for urgent intubation in neonates. A total of 226 neonates requiring intubation either in the delivery room or neonatal intensive care unit (NICU) were enrolled and stratified by gestational age into two groups: less than 32 weeks and 32 weeks or more. The study primarily focused on the success rate of the first intubation attempt, monitored through exhaled carbon dioxide detection.
Main Findings: The trial included 214 neonates, analyzing the success of intubation on the first attempt. Video laryngoscopy significantly outperformed direct laryngoscopy, achieving a first-attempt success rate of 74% (95% confidence interval [CI], 66 to 82) compared to 45% (95% CI, 35 to 54) in the direct laryngoscopy group. Moreover, the median number of attempts for successful intubation was lower in the video-laryngoscopy group (1 attempt, 95% CI, 1 to 1) versus the direct-laryngoscopy group (2 attempts, 95% CI, 1 to 2). Additionally, neonates in the video laryngoscopy group experienced higher median lowest oxygen saturations and heart rates during intubation.
Implications for Practice: The findings suggest that video laryngoscopy could be more effective than direct laryngoscopy for urgent neonatal intubation, particularly in increasing the likelihood of success on the first attempt. These results recommend reconsidering current intubation techniques in neonatal care settings to incorporate video laryngoscopy, potentially leading to safer and more efficient intubation processes in this vulnerable population.
Reference (link to abstract – $ for full-text):
Prospective Validation Study: High accuracy of PECARN rules in reducing unnecessary CT scans in pediatric blunt trauma – Lancet Child Adolesc Health
5 May, 2024 | 15:08h | UTCStudy Design and Population:
This multicenter prospective validation study tested the Pediatric Emergency Care Applied Research Network (PECARN) prediction rules aimed at reducing unnecessary CT scans for children presenting with blunt abdominal or minor head trauma. Over a nearly five-year period, children and adolescents under 18 from six U.S. emergency departments in cities including Sacramento, Dallas, and Los Angeles were enrolled. Exclusion criteria included pregnancy, pre-existing neurological disorders, penetrating trauma, injuries older than 24 hours, prior CT or MRI scans, or suspicion of non-accidental trauma.
Main Findings:
A total of 7,542 children with blunt abdominal trauma and 19,999 with minor head trauma were enrolled. The intra-abdominal injury rule demonstrated a sensitivity and negative predictive value (NPV) of 100%, confirming its reliability in detecting injuries requiring acute intervention. For head traumas, the sensitivity varied slightly with age; 100% for children under 2 years and 98.8% for those aged 2 years and older, with an NPV of 100% in both groups. Only two cases in the older cohort were misclassified, neither requiring neurosurgery.
Implications for Practice:
The validation of PECARN rules with high sensitivity and NPV supports their use as a safe guideline to minimize unnecessary CT scans in pediatric trauma cases, thereby promoting efficient use of resources and reducing exposure to radiation in children. These results suggest that implementation of these rules should be considered in emergency pediatric care to improve outcomes and healthcare efficiency.
Reference (link to abstract – $ for full-text):
A novel comprehensive algorithm for evaluation of pediatric ICU patients with new fever or instability
7 Aug, 2023 | 14:53h | UTC
Caring for two in the ICU: pharmacologic management of pregnancy-related complications
7 Aug, 2023 | 14:31h | UTCCaring for two in the ICU: Pharmacologic management of pregnancy-related complications – Pharmacotherapy (free for a limited period)
M-A | Exploring perinatal interventions and their impact on severe intraventricular hemorrhage in preterm neonates
4 Aug, 2023 | 11:56h | UTC
Commentary on Twitter
A meta-analysis by @DrAbdulRazak_MD & colleagues on perinatal interventions are associated with a reduction or increase of IVH and PVL #EBNEOalerts #neoEBM #neotwitter https://t.co/SPzNHwy3HD pic.twitter.com/KDQBSYZjdq
— Evidence-Based Neo (@EBNEO) April 26, 2023
RCT – 2ry analysis | Use of NIPPV, NHFOV post-extubation outperforms NCPAP in neonates with severe respiratory failure or extremely preterm
4 Aug, 2023 | 11:48h | UTC
Commentary on Twitter
2nd analysis of NASONE trial in @JAMANetworkOpen examines whether NHFOV is superior in reducing the duration of IMV in comparison to NIPPV and NCPAP in infants born < 28 weeks https://t.co/oWqvO4E5QF
2022 NASONE study: https://t.co/1rfZpaIseN #EBNEOalerts #neoEBM #neotwitter pic.twitter.com/w3Au8s62K7
— Evidence-Based Neo (@EBNEO) July 5, 2023
Systematic Review | NIPPV potentially superior to NCPAP in reducing reintubation in extubated preterm neonates
4 Aug, 2023 | 11:46h | UTC
Practice Guidance | Management of febrile neutropenia in immunocompetent children and youth
3 Aug, 2023 | 13:38h | UTC
Systematic Review | Probiotics’ potential in preventing necrotizing enterocolitis in very preterm, VLBW infants warrants further research
31 Jul, 2023 | 13:51h | UTC
M-A | Early NIPPV likely reduces the risk of respiratory failure and intubation in very preterm infants
25 Jul, 2023 | 13:39h | UTC
RCT | Preterm infants show same feeding tolerance with NCPAP or HHHFNC
20 Jul, 2023 | 11:01h | UTC
Retrospective Analysis | Inconsistencies in pediatric drug dosing found in over half of prehospital emergency drug administrations
17 Jul, 2023 | 13:50h | UTCCommentaries:
Children and Drug Dosing Variations When in Transit to the Hospital – AAP Journals Blog
Variation Seen in Dosing of Meds at Prehospital Pediatric Encounters – HealthDay
Cohort Study | Intermittent hypoxemia is associated with unfavorable respiratory outcomes in extremely preterm infants
17 Jul, 2023 | 13:28h | UTC
M-A | HFNC, CPAP, BiPAP prove more effective than conventional oxygen therapy in minimizing pediatric extubation failure
19 Jun, 2023 | 13:35h | UTC
Commentary on Twitter
Study suggests that CPAP, HFNC, and BiPAP were more effective than conventional oxygen therapy for providing postextubation noninvasive respiratory support in a pediatric population. https://t.co/d56eNkP8QP @abusultaneh @RobyKhemaniMD @PALISInet
— JAMA Pediatrics (@JAMAPediatrics) June 5, 2023
Review | Point-of-care thoracic ultrasound in children: new advances in pediatric emergency setting
16 Jun, 2023 | 13:59h | UTC
AAP Technical Report | Dispensing medications at the hospital upon discharge from an emergency department
14 Jun, 2023 | 14:33h | UTCDispensing Medications at the Hospital Upon Discharge From an Emergency Department – Pediatrics
News Release: Report discusses ways to improve medication adherence after emergency visit – AAP News
Commentary: Dispensing Meds in Emergency Department Likely to Improve Adherence – HealthDay
Current recommendations for the management of pediatric diabetic ketoacidosis
25 May, 2023 | 11:31h | UTC
SR | Balanced crystalloid solutions versus 0.9% saline for treating acute diarrhea and severe dehydration in children
25 May, 2023 | 11:15h | UTC
SR | Videolaryngoscopy vs. direct laryngoscopy for tracheal intubation in neonates
24 May, 2023 | 13:11h | UTCVideolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates – Cochrane Library
Commentary on Twitter
Videolaryngoscopy:
– may increase the success of intubation on 1st attempt and result in fewer intubation attempts, but may not reduce the time required for successful intubation
– likely results in a reduced incidence of airway‐related adverse effectshttps://t.co/ney0pt8PnH pic.twitter.com/lc6bbDME7e— Cochrane Neonatal (@CochraneNeonate) May 12, 2023
SR | Nasal high flow therapy for primary respiratory support in preterm infants
12 May, 2023 | 13:31h | UTCNasal high flow therapy for primary respiratory support in preterm infants – Cochrane Library
Summary: Nasal high flow therapy for breathing support in preterm babies – Cochrane Library
Commentary on Twitter
Nasal high flow therapy for primary respiratory support in preterm infants – 2023 updatehttps://t.co/6UEnZ8fJRS @AmerAcadPeds @ESPR_ESN pic.twitter.com/yLBcQPPPvS
— Cochrane Neonatal (@CochraneNeonate) May 6, 2023
Review | Pediatric pericarditis
9 May, 2023 | 14:42h | UTCPediatric Pericarditis: Update – Current Cardiology Reports
Review | Rapid sequence induction in pediatric anesthesia
4 May, 2023 | 13:26h | UTC
RCT | Cerebral oximetry monitoring fails to reduce death or severe brain injury in extremely preterm infants
25 Apr, 2023 | 14:45h | UTCCerebral Oximetry Monitoring in Extremely Preterm Infants – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary on Twitter
In extremely preterm infants, the use of cerebral oximetry monitoring to guide treatment for the first 72 hours after birth did not reduce the risk of death or severe brain injury at 36 weeks’ postmenstrual age. Full study: https://t.co/JX7Ra3OpjM pic.twitter.com/VACbUUAq3i
— NEJM (@NEJM) April 19, 2023