Instanyl (fentanyl) / Takeda - LARVOL DELTA

Practice-Change Pathway to Reduce Procedural Distress During Intussusception Reduction-A Quality Improvement Initiative. (PubMed, Pediatr Emerg Care) - "This QI initiative improved rates of analgesic and anxiolytic provision to reduce distress in patients undergoing intussusception reduction, without adverse outcomes. This project highlights the effectiveness of structured interventions in optimizing pediatric procedural pain management and potentially serves as a model for spread to other pediatric emergency departments."

Journal • Anesthesia • Gastrointestinal Disorder • Pain • Pediatrics

Comparison of inhalational methoxyflurane, intranasal fentanyl, and intravenous morphine for treatment of prehospital acute pain in Norway (PreMeFen): a randomised, non-inferiority, three-arm, phase 3 trial. (PubMed, Lancet) - P3 | "Inhalational methoxyflurane is non-inferior to intranasal fentanyl and intravenous morphine for acute pain management in the prehospital environment, assessed 10 min after administration. Inhalational methoxyflurane serves as a valuable non-intravenous alternative in the early phase of treatment and might bridge the gap to longer-acting analgesics."

Head-to-Head • Journal • P3 data • CNS Disorders • Depression • Pain • Psychiatry

Standardized Clinical Pathways Improve Management of Vaso-Occlusive Episodes in the Pediatric Emergency Department (ASH 2023) - "A total of 0 (0%) hydromorphone PCAs were administered in the ED in the pre-pathway cohort compared to 4 (3.8%) hydromorphone PCA administered in the ED in the post-pathway cohort... Standardizing pain management using a clinical pathway has shown improvement in ED management of VOE in the first year post implementation with increased utilization of intranasal fentanyl and PCAs. Our goal of increased percentage of patients receiving pain medication within 30 minutes and decreased time to first analgesic was not achieved, however this is an ongoing project and with education in implementation of the clinical pathway we hope to continue to see long term progress. Additionally, in the future, we plan to expand use of this pathway to additional sites within our health care system."

Clinical • Anesthesia • Genetic Disorders • Hematological Disorders • Pediatrics • Sickle Cell Disease

Variability in Internal Algorithms for Sickle Cell Disease (ASH 2024) - "Intranasal fentanyl was recommended by 31 algorithms, with individualized pain protocol and non-pharmacological measures mentioned in 19 each. Despite technical challenges, most protocols recommended exchange transfusion for severe ACS, in line with national guidelines.Conclusion : Despite the presence of national guidelines, internal algorithms for VOC and ACS in pediatric SCD show great variability, likely due to the lack of robust evidence supporting specific recommendations in national guidelines. Prospective studies are crucial to fill these evidence gaps with the overall goal of improving patient care."

Genetic Disorders • Hematological Disorders • Pediatrics • Sickle Cell Disease

Improving the Care of Adults with Sickle Cell Disease in a Large Tertiary Hospital Emergency Department By Incorporating Patients' and Providers' Feedback (ASH 2024) - "Our goal is to increase the percentage of all patients who receive opioids within 60 minutes from 19.1% to at least 50% by December 2025.Priority change ideas include ongoing nurse training in port access and the use of vein-finding ultrasounds, staff education on VOC management, subcutaneous opioid administration or intranasal fentanyl to reduce opioid wait times, and the integration of individualized pain plans into medical records. Data are being collected with the help of information technology to assess trends.We strongly recommend the assessment of opioid wait times as an essential ED QI measure. Both patients' and providers' opinions should be considered when developing plan-do-study-act cycles (PDSA) and change ideas."

Clinical • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

Feasibility, Safety and Effectiveness of Intranasal Fentanyl in the Treatment of Acute Pain Episodes Among Adults with Sickle Cell Disease: A Retrospective Single Center Study (ASH 2024) - "Twenty (86%) patients were receiving treatment with hydroxyurea, and 5 (21%) were undergoing regular erythrapheresis...On presentation, all patients received co-analgesia with non-steroidal anti-inflammatory drugs, and all received subsequent doses of parenteral opioids, with a median dose of 12.5 mg (5-50 mg) morphine equivalents...The use of INF has been widely accepted in the pediatric population with SCD and it has been shown to be effective in adults with chronic and cancer related pain. Standardized protocols which incorporate INF should therefore be considered in the management of adults with SCD, and further research on its relative effectiveness compared to traditional parenteral routes of administration, as well as patient preferences, are needed."

Retrospective data • Cardiovascular • CNS Disorders • Depression • Dermatology • Genetic Disorders • Hematological Disorders • Hypotension • Pain • Pediatrics • Pruritus • Psychiatry • Sickle Cell Disease

Intranasal Fentanyl and the Impact of an Emergency Department Pain Protocol on Hospital Admission Rates (ASH 2024) - "Our study illustrated the significant impact a standardized treatment algorithm created with a multidisciplinary group of champions can have on time to the first dose of analgesia and outcomes such as hospitalization rates, suggesting improved pain management. Future work will be focused on understanding how these systems and clinical improvements translate to patient experience and patient-reported outcomes."

Clinical • Genetic Disorders • Hematological Disorders • Pain • Pediatrics • Sickle Cell Disease

Intranasal Fentanyl and Impact of an Emergency Department Pain Protocol for Sickle Cell Disease on Hospitalization Rates. (PubMed, Blood Adv) - "Implementing a standardized ED SCD pain protocol improved timeliness and consistency in analgesia administration and decreased overall hospitalization rates. This study also highlights the role of INF as an effective initial analgesic within standardized ED protocols for pediatric VOC."

Journal • Genetic Disorders • Hematological Disorders • Pain • Pediatrics • Sickle Cell Disease

Feasibility, safety and efficacy of intranasal fentanyl in the treatment of acute pain episodes among adults with sickle cell disease: A retrospective single-centre study. (PubMed, Br J Haematol) - No abstract available

Journal • Retrospective data • Genetic Disorders • Hematological Disorders • Pain • Sickle Cell Disease

Assessment and treatment of pain in children presenting to the Emergency Department with acute bony injuries: an audit (EUSEM 2025) - "While the results from Cycle 2 demonstrated an improvement in almost all target areas of the audit, Cycle 3 demonstrates a decrease in awareness for appropriate analgesic choices for children with bony injuries. The next step will be to encourage staff to record pain scores and to educate staff on the use of intranasal fentanyl."

Clinical • Pain • Pediatrics

Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (INFENT PICC): A Feasibility Randomized Controlled Trial. (PubMed, Children (Basel)) - P3 | " Major modifications to the recruitment strategy would be required to progress to a definitive RCT. Strategies facilitating IN fentanyl adoption for procedural analgesia in the NICU are needed."

Journal • Critical care • Pain

Intranasal Versus Intravenous Fentanyl For Procedural Analgesia in Preterm Neonates (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: Ain Shams University

New P1 trial • Pain

Ibuprofen and Sumatriptan in the Management of Headaches in Young People - A Systematic Review (IHC 2025) - "In emergency settings, a combination of intranasal fentanyl (1.5μg/kg) with ibuprofen suggested potential additive benefits; however, the results lacked statistical significance...In contrast, transdermal iontophoretic sumatriptan yielded modest therapeutic effects and a relatively high incidence of local adverse events. Although both agents exhibit therapeutic potential, additional randomized controlled trials are warranted to more comprehensively assess their safety and efficacy profiles in pediatric headache management."

Review • CNS Disorders • Migraine

Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Nationwide Children's Hospital | N=180 ➔ 0 | Trial completion date: Dec 2023 ➔ Oct 2025 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Dec 2023 ➔ Oct 2025

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • CNS Disorders • Mood Disorders • Pain • Pediatrics • Psychiatry

Pain Managment in Preterm Neonates (clinicaltrials.gov) - P2/3 | N=52 | Completed | Sponsor: Ain Shams University

New P2/3 trial • Pain

FIREFLY: Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: IWK Health Centre

New P1/2 trial • Critical care • Pain • Retinal Disorders • Retinopathy of Prematurity

Procedural Pain Management in Patients with Cerebral Palsy Undergoing Botulinum Toxin Injection: A Systematic Review and Meta-Analysis. (PubMed, Toxins (Basel)) - "All the techniques are safe, if administered in an appropriate setting. Deep sedation is more effective in pain control but requires an anesthetist. A combined individualized approach is preferrable. PROSPERO CRD42025639999."

Clinical • Journal • Retrospective data • Review • Anesthesia • Cerebral Palsy • CNS Disorders • Movement Disorders • Pain

A randomised controlled trial of interventions to reduce the pain and distress of nasogastric tube insertion in young children. (ANZCTR) - P=N/A | N=468 | Not yet recruiting | Sponsor: Monash University

New trial • Pain

Comparing Analgesic Efficacy of Intranasal Fentanyl Using Mucosal Atomization Device Versus Intravenous Fentanyl for Management of Breakthrough Pain in Head and Neck Cancer Patients: A Randomized Clinical Trial. (PubMed, J Maxillofac Oral Surg) - "Onset of action of drug was an average of 5 min in group A and 15 min in group B. No incidence of bradycardia, hypotension was seen in both the groups. We concluded that intranasal administration of fentanyl provides better postoperative breakthrough pain relief and opioids are the rescue medication of choice for breakthrough pain and it should be individually titrated as needed to achieve adequate pain relief while minimizing the risk of side effects."

Clinical • Journal • Cardiovascular • Head and Neck Cancer • Hypotension • Oncology • Oral Cancer • Pain • Solid Tumor

Variability in the Recommendations for Management of Vaso-Occlusive Crisis and Acute Chest Syndrome in Sickle Cell Disease: Review of Institutional Algorithms of Pediatric Hospitals Across the United States. (PubMed, J Pediatr Hematol Oncol) - "Intranasal fentanyl was recommended by 31 algorithms. Intravenous fluid management strategies were highly variable, and hypotonic fluids were recommended in 6 VOC and 4 ACS algorithms. Overall, internal algorithms for pediatric SCD showed variability compared with each other and with national guidelines, likely due to the lack of robust evidence supporting specific recommendations."

Journal • Genetic Disorders • Hematological Disorders • Pediatrics • Sickle Cell Disease

Decreasing time to narcotic pain medication in patients presenting with acute sickle cell pain crisis in a pediatric emergency department: a quality improvement initiative (PAS 2025) - "The ED averaged 21 patients presenting for sickle cell pain crisis per month. We met our aim in decreasing time to first narcotic, as well as increasing the percentage of patients receiving their narcotic < 60 minutes, both exhibiting center-line shifts (Fig 2). We saw a decrease in disparity regarding time to first narcotic between patients with low/very low COI (72 min to 51 min) and high/very high COI (58 min to 55 min), a reduction by 29.2% and 4.5% respectively."

Clinical • Genetic Disorders • Hematological Disorders • Pain • Pediatrics • Sickle Cell Disease

Effectiveness and safety of intranasal fentanyl for pain management in infants aged 0-6 months: a systematic review protocol. (PubMed, JBI Evid Synth) - "Data synthesis will combine findings using statistical models, or narrative summaries when meta-analysis is not feasible. PROSPERO CRD42024551524."

Journal • Pain

ANTAMIN: Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine Vs Oral Morphine (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Assistance Publique - Hôpitaux de Paris | Not yet recruiting ➔ Recruiting

Enrollment open • Pain • Pediatrics

INFENT PICC: Intranasal Fentanyl in Preterm Infants Undergoing Peripherally Inserted Central Catheter Placement (clinicaltrials.gov) - P3 | N=8 | Completed | Sponsor: Mount Sinai Hospital, Canada | Recruiting ➔ Completed | N=30 ➔ 8

Enrollment change • Trial completion • Pain

TraumaDol: Evaluation of the "Intranasal Fentanyl" Protocol in Pediatric Surgical Emergencies at Strasbourg University Hospital (clinicaltrials.gov) - P=N/A | N=500 | Recruiting | Sponsor: University Hospital, Strasbourg, France

New trial • Musculoskeletal Diseases • Musculoskeletal Pain • Pain • Pediatrics