Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT06927193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regional Analgesia at the Pediatric Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2025-04-06', 'studyFirstSubmitQcDate': '2025-04-13', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Any complication', 'timeFrame': '2 years', 'description': 'Any complication that happend to the patient because of the regional anaesthesia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Regional Anaesthesia']}, 'referencesModule': {'references': [{'pmid': '38563828', 'type': 'BACKGROUND', 'citation': 'Katzir Y, Ganor L, Berant R, Shahar-Nissan K. Building Blocks-A Block-by-Block Approach to Better Emergency Care in Children. Pediatr Emerg Care. 2024 Jun 1;40(6):463-468. doi: 10.1097/PEC.0000000000003201. Epub 2024 Apr 2.'}, {'pmid': '36449743', 'type': 'BACKGROUND', 'citation': 'Shahar-Nissan K, Berant R, Ganor L, Katzir Y. Ultrasound-Guided Supraclavicular Brachial Plexus Blocks Performed by Pediatric Emergency Medicine Physicians for Painful Orthopedic Procedures in a Pediatric Emergency Department-A Case Series. Pediatr Emerg Care. 2022 Dec 1;38(12):e1684-e1687. doi: 10.1097/PEC.0000000000002878. Epub 2022 Nov 18.'}, {'pmid': '26974975', 'type': 'BACKGROUND', 'citation': 'Ruest S, Anderson A. Management of acute pediatric pain in the emergency department. Curr Opin Pediatr. 2016 Jun;28(3):298-304. doi: 10.1097/MOP.0000000000000347.'}, {'pmid': '30074928', 'type': 'BACKGROUND', 'citation': 'Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.'}, {'pmid': '25803747', 'type': 'BACKGROUND', 'citation': 'Frenkel O, Liebmann O, Fischer JW. Ultrasound-guided forearm nerve blocks in kids: a novel method for pain control in the treatment of hand-injured pediatric patients in the emergency department. Pediatr Emerg Care. 2015 Apr;31(4):255-9. doi: 10.1097/PEC.0000000000000398.'}, {'pmid': '26626896', 'type': 'BACKGROUND', 'citation': 'Baker MD, Gullett JP. Ultrasound-Guided Femoral Nerve Blocks. Pediatr Emerg Care. 2015 Dec;31(12):864-8; quiz 869-71. doi: 10.1097/PEC.0000000000000634.'}, {'pmid': '35245015', 'type': 'BACKGROUND', 'citation': 'Heffler MA, Brant JA, Singh A, Toney AG, Harel-Sterling M, Grandjean-Blanchet C, Riera A, Khalil PA, Starr-Seal RL, Binder ZW. Ultrasound-Guided Regional Anesthesia of the Femoral Nerve in the Pediatric Emergency Department. Pediatr Emerg Care. 2023 Feb 1;39(2):e30-e34. doi: 10.1097/PEC.0000000000002607. Epub 2022 Jan 12.'}, {'pmid': '11561692', 'type': 'BACKGROUND', 'citation': 'Argiris A, Heald P, Kuzel T, Foss FM, DiStasio S, Cooper DL, Arbuck S, Murren JR. Phase II trial of 9-aminocamptothecin as a 72-h infusion in cutaneous T-cell lymphoma. Invest New Drugs. 2001;19(4):321-6. doi: 10.1023/a:1010613912335.'}]}, 'descriptionModule': {'briefSummary': 'Approximately two years ago, ultrasound-guided regional blocks technique was introduced into routine use in the pediatric emergency department at Hillel Yaffe Medical Center. Since then, nearly 300 different blocks have been performed.\n\nStudy Objective: To collect a registry database of complication rates associated with regional analgesia during routine pediatric emergency department care between 2023 and 2025.', 'detailedDescription': 'Adequate pain management is a key component of pediatric emergency care. The use of regional analgesia, particularly ultrasound-guided regional blocks, has gained momentum in recent years as part of pain management, reducing the need for opioids and serving as a safe and effective alternative to procedural sedation.\n\nFor anesthesiologists, this is now a routine tool mainly performed in the operating room. In adult emergency medicine, this tool has also been integrated and is sometimes performed by emergency physicians.\n\nIn children, performing ultrasound-guided regional blocks presents additional challenges compared to adults. The primary challenge in an unsedated child is maintaining cooperation throughout the procedure. Other difficulties include limited maneuverability due to their smaller size, reduced allowable volume of local anesthetics (based on weight), and more. For these reasons, most ultrasound-guided regional blocks in children are performed in the operationg room after sedation or general anesthesia. There are only a few case reports describing the use of simple ultrasound-guided regional blocks performed by emergency physicians in pediatric ED settings.\n\nApproximately two years ago, this technique was introduced into routine use in the pediatric emergency department at Hillel Yaffe Medical Center. Since then, nearly 300 different blocks have been performed.\n\nStudy Objective: To collect a registry database of complication rates associated with regional analgesia during routine pediatric emergency department care between 2023 and 2025.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children who visited the pediatric emergency department between 2023-2025', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children who visited the pediatric emergency department between 2023-2025 and underwent a nerve block during their visit.\n\nExclusion Criteria:\n\n* Children who visited the emergency department but had the nerve block performed outside the emargency department setting (e.g., inpatient wards or operationg room), or if the block was performed by a physician not affiliated with the pediatric emergency department.'}, 'identificationModule': {'nctId': 'NCT06927193', 'briefTitle': 'Regional Analgesia at the Pediatric Emergency Department', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Regional Analgesia at the Pediatric Emergency Department', 'orgStudyIdInfo': {'id': '0035-25-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Regional anaesthesia', 'description': 'Children who underwent regional analgesia during routine pediatric emergency department', 'interventionNames': ['Procedure: Regional anaesthesia']}], 'interventions': [{'name': 'Regional anaesthesia', 'type': 'PROCEDURE', 'description': 'Regional anaesthesia', 'armGroupLabels': ['Regional anaesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'contacts': [{'name': 'Erez Nadir, MD', 'role': 'CONTACT', 'email': 'erezn@hymc.gov.il', 'phone': '+9724744379'}], 'facility': 'Hillel Yaffe medical center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Erez Nadir, MD', 'role': 'CONTACT', 'email': 'erezn@hymc.gov.il', 'phone': '+9724774379'}], 'overallOfficials': [{'name': 'Erez Nadir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neonatologist', 'investigatorFullName': 'Erez Nadir, MD', 'investigatorAffiliation': 'Hillel Yaffe Medical Center'}}}}