Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
Study NCT ID:
NCT05208892
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2022-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Use in SZMN Blocks for Pediatric T&A Pain Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'All three groups will receive a small circular band-aid on their temples (site of suprazygomatic maxillary nerve block placement).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients in the two intervention groups will receive bilateral suprazygomatic maxillary nerve block such that 5 mL of local anesthetic is deposited on each side. Patients in the SZMN+Dexmedetomidine group will receive Dexmedetomidine in addition to the local anesthetic with placement of the suprazygomatic maxillary nerve block (0.25 mcg/kg on each side for a total dose of 5 mcg/kg, max 20 mcg total).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Surgical Pain', 'timeFrame': 'Time Frame: 14 days after surgery', 'description': 'Patients will rate their pain on a 0-10 scale'}, {'measure': 'Postoperative Opioid Consumption', 'timeFrame': 'Time Frame: 14 days after surgery', 'description': 'Amount of pain medications consumed by patients will be recorded'}], 'secondaryOutcomes': [{'measure': 'Post-operative nausea, vomiting, delirium, ability to tolerate oral intake, bleeding, respiratory events, hospital readmission, time to discharge readiness', 'timeFrame': 'Time Frame: 14 days after surgery', 'description': 'Adverse events following the procedure will be monitored and recorded'}, {'measure': 'Complications from block', 'timeFrame': 'Time Frame: 14 days after surgery', 'description': 'Nerve block complications will be monitored and recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Suprazygomatic maxillary nerve block', 'Tonsillectomy and Adenoidectomy', 'Regional Anesthesia', 'Dexmedetomidine', 'Pediatric'], 'conditions': ['Postoperative Pain', 'Opioid Use']}, 'referencesModule': {'references': [{'pmid': '18983373', 'type': 'BACKGROUND', 'citation': 'Grainger J, Saravanappa N. Local anaesthetic for post-tonsillectomy pain: a systematic review and meta-analysis. Clin Otolaryngol. 2008 Oct;33(5):411-9. doi: 10.1111/j.1749-4486.2008.01815.x.'}, {'pmid': '24525630', 'type': 'BACKGROUND', 'citation': 'Chiono J, Raux O, Bringuier S, Sola C, Bigorre M, Capdevila X, Dadure C. Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. Anesthesiology. 2014 Jun;120(6):1362-9. doi: 10.1097/ALN.0000000000000171.'}]}, 'descriptionModule': {'briefSummary': 'The suprazygomatic maxillary nerve (SZMN) block is a well-established, safe and effective regional technique for pain management following cleft palate procedures. However, it has not been studied for patients undergoing tonsillectomy and adenoidectomy (T\\&A) procedures. The goal of this study is to determine whether the SZMN block can be utilized to improve pain control and decrease morbidity in pediatric patients undergoing T\\&A. An additional goal will be to determine whether the use of dexmedetomidine as a local anesthetic adjunct can prolong the analgesic effects of the SZMN block to cover the entire duration of pain experienced.', 'detailedDescription': 'Patients between 6 months and 18 years undergoing T\\&A surgical procedures will be reviewed for potential study enrollment. If participants agree to participate, they will be randomized into one of the three groups:\n\n* the suprazygomatic maxillary nerve (SZMN) block treatment cohort\n* the SZMN block with Dexmedetomidine treatment cohort\n* the control cohort (standard of care).\n\nAfter anesthesia induction, patients randomized into the SZMN-treatment group or SZMN+Dexmedetomidine treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room.\n\nParticipants enrolled into the control group will receive the standard of care with no changes to their anesthetic or surgical care. This group will not receive the SZMN block.\n\nPostoperative pain scores and opioid consumption for all three groups will be collected in the PACU and for each postoperative day for a total of 14 postoperative days. We will also collect the following data: time to discharge readiness, postoperative nausea/vomiting, emergence delirium, oxygen desaturation and respiratory events, ability to tolerate oral intake, bleeding, hospital readmission, and adverse events related to the nerve block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 6 months - 18 years\n* Give consent/parental consent to participate in study\n* Patients undergoing tonsillectomy and adenoidectomy\n\nExclusion Criteria:\n\n* Participants who do not consent or have parental consent\n* Patients who require urgent/emergent intervention\n* Patients who undergo additional combined surgical procedures with separate incisions (in addition to the adenotonsillectomy)\n* Patients with known difficult airway, clinical hemodynamic instability, coagulopathy, chronic pain history, chronic pain medication use, and unrepaired congenital heart disease\n* Patients under age 6 months'}, 'identificationModule': {'nctId': 'NCT05208892', 'briefTitle': 'Dexmedetomidine Use in SZMN Blocks for Pediatric T&A Pain Control', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Dexmedetomidine Use in Suprazygomatic Maxillary Nerve Blocks for Pediatric Adenotonsillectomy Pain Control', 'orgStudyIdInfo': {'id': '64309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SZMN Treatment Group', 'description': 'Patients randomized into the SZMN treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthetic per side.', 'interventionNames': ['Procedure: SZMN block']}, {'type': 'EXPERIMENTAL', 'label': 'SZMN+Dexmedetomidine Treatment Group', 'description': 'Patients randomized into the SZMN+Dexmedetomidine treatment group will receive bilateral single injection SZMN blocks under general anesthesia in the operating room. The injection will occur through the pterygomaxillary fissure into the pterygomaxillary fossa. Patients will receive 5 ml of local anesthetic along with 0.25 mcg/kg (max 10 mcg) Dexmedetomidine on each side (total of 0.5 mcg/kg, total max 20 mcg).', 'interventionNames': ['Procedure: SZMN block with Dexmedetomidine']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention: Control Group', 'description': 'Patients in this group will receive the standard of care for T\\&A procedures within the pediatric population.'}], 'interventions': [{'name': 'SZMN block', 'type': 'PROCEDURE', 'description': 'Suprazygomatic Maxillary Nerve (SZMN) Blocks bilaterally', 'armGroupLabels': ['SZMN Treatment Group']}, {'name': 'SZMN block with Dexmedetomidine', 'type': 'PROCEDURE', 'description': 'Suprazygomatic Maxillary Nerve (SZMN) Blocks with local anesthetic and Dexmedetomidine bilaterally', 'armGroupLabels': ['SZMN+Dexmedetomidine Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Pan, MD', 'role': 'CONTACT'}], 'facility': 'Lucile Packard Childrens Hospital', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Ban CH Tsui, MD', 'role': 'CONTACT', 'email': 'bantsui@stanford.edu', 'phone': '(650) 200-9107'}, {'name': 'Ksenia Kasimova, MD', 'role': 'CONTACT', 'email': 'kasimova@stanford.edu', 'phone': '(650) 788-9458'}], 'overallOfficials': [{'name': 'Ban CH Tsui, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stanford University'}, {'name': 'Stephanie Pan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Stephanie Jiaying Pan', 'investigatorAffiliation': 'Stanford University'}}}}