[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651526":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":26,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":44,"enrollmentInfo":45,"targetDuration":26,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":58,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":26},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Topical Magnesium Sulfate","EXPERIMENTAL","Participants in this group will have a sterile gauze soaked in 5 mL of 20% magnesium sulfate (2 mg\u002Fkg) packed into the tonsillar fossa for 5 minutes post-hemostasis.",[13],"Drug: Magnesium Sulfate",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B: Peritonsillar Bupivacaine","ACTIVE_COMPARATOR","Participants in this group will receive an injection of 2 mL of 0.25% bupivacaine directly into the peritonsillar space, specifically at the superior, middle, and inferior poles.",[19],"Drug: Bupivacaine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Magnesium Sulfate","Topical application via a sterile gauze soaked in 5 mL of 20% magnesium sulfate (2mg\u002Fkg) packed into the fossa for 5 minutes post-hemostasis.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Bupivacaine","Peritonsillar infiltration involving the injection of 2 mL of 0.25% bupivacaine into the superior, middle, and inferior poles of the peritonsillar space.",[15],{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Abd El-Rahman Ahmed Aboulwafa","Resident of Otolaryngology","100651526","phase-4-topical-magnesium-sulfate-versus-peritonsillar-bupivacaine-for-post-tonsillectomy-pain-relief-in-children-100651526",false,"NCT07760207","Topical Magnesium Sulfate Versus Peritonsillar Bupivacaine for Post-Tonsillectomy Pain Relief in Children","Topical Magnesium Sulfate Versus Peritonsillar Bupivacaine Infiltration for Post-Tonsillectomy Analgesia: A Prospective, Randomized Trial","Inclusion Criteria:\n\n* Pediatric patients aged 8-15 years undergoing elective tonsillectomy.\n\nExclusion Criteria:\n\n* Patients younger than 8 years or older than 15 years.\n* Known allergy to magnesium sulfate or bupivacaine.\n* Pre-existing neurological disorders (for example, neuromuscular diseases, epilepsy) that could affect pain perception or magnesium metabolism.\n* Pre-existing cognitive impairment or developmental delay affecting pain assessment.\n* Chronic pain syndromes or regular use of analgesics.\n* Coagulopathy or bleeding disorders.","ALL","8 Years","15 Years",{"count":46,"type":47},40,"ESTIMATED","INTERVENTIONAL",[50],"PHASE4","Tonsillectomy (tonsil removal) is a very common surgery for children, but it often causes significant throat and ear pain afterward. Doctors usually inject a numbing medicine, such as bupivacaine, into the area around the tonsils to help control this pain. However, these injections require needles, which can cause swelling, distort tissue, and slightly increase the risk of bleeding or infection, and the pain relief typically only lasts for about 4 to 6 hours.\n\nThis study is investigating a needle-free alternative to see if it provides effective pain relief. The researchers are testing a medication called magnesium sulfate, which blocks certain pain receptors and can be applied directly to the surgical site using a soaked gauze pad instead of a needle injection.\n\nThe main goal of this clinical trial is to compare how well topical magnesium sulfate relieves pain compared to standard bupivacaine injections in children undergoing tonsillectomy.\n\nThe study will include 40 children between the ages of 8 and 15 years old. During the surgery, while under general anesthesia, half of the children will receive the topical magnesium sulfate pad applied to the surgical area for 5 minutes, and the other half will receive the standard bupivacaine injection. After the surgery, researchers will measure the children's pain levels using visual pain scales featuring faces and numbers. They will also track how much extra pain medication the children need, how well their surgical wounds heal, and if they experience any adverse effects.",[53,54,55,56,57],"Post-tonsillectomy Pain","Tonsillectomy","Postoperative Pain","Tonsillectomy Distress Syndrome","Odynophagia",[54,23,28,59,60,61],"Analgesia","Pediatric","Peritonsillar Infiltration","NOT_YET_RECRUITING","2026-08-07",{"date":65,"type":66},"2026-08-12","ACTUAL",{"date":68,"type":47},"2026-09",{"date":70,"type":47},"2027-10",{"name":5,"class":6}]