[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568094":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":28,"responsibleParty":44,"collaborators":18,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":18,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":72,"whyStopped":18,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"KK Women's and Children's Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group","EXPERIMENTAL","Study group will receive Difflam spray by delivering 4 sprays to the posterior pharynx. Patients will be asked to swallow after each spray. Questionnaires will then be administered to the patients 10 minutes after administration of the intervention, and then 4 hours after for their pain scores and side effects, if any.",[13],"Drug: Benzydamine Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Patients will be asked to fill in questionnaires for their pain scores and side effects, if any.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Benzydamine Hydrochloride","The Difflam Forte Anti-Inflammatory Throat Spray (iNova Pharmaceuticals Pte Ltd, Singapore) is an over-the-counter medication indicated for temporary relief of painful mouth and throat conditions. It contains benzydamine hydrochloride (BH) 3 mg\u002FmL, a non-steroidal anti-inflammatory agent (NSAID), and is recommended for adults to spray 2 to 4 times to the affected throat every 1.5 to 3 hours as needed.",[9],[26,27],"benzydamine hydrochloride 3 mg\u002FmL","Difflam Forte Anti-Inflammatory Throat Spray",[29],{"facility":5,"status":18,"city":30,"state":18,"zip":18,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Singapore","SG",{"type":33,"coordinates":34},"Point",[35,36],103.85007,1.28967,{"lat":36,"lon":35},[39],{"name":40,"role":41,"phone":42,"phoneExt":18,"email":43},"Ban Leong Sng","CONTACT","65 6394 8436","sng.ban.leong@singhealth.com.sg",{"type":45,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100568094","early-phase-1-benzydamine-hydrochloride-and-post-operative-sore-throat-100568094",false,"NCT06676748","Benzydamine Hydrochloride and Post-operative Sore Throat","The Effect of Benzydamine Hydrochloride Spray on Post-operative Sore Throat: a Randomized Controlled Study","DIFFLAM","Inclusion Criteria:\n\n1. American Society of Anaesthesiologists (ASA) physical status 1-2\n2. Female patients having laryngeal mask airway (LMA) for airway management for surgery in KKH;\n3. BMI \\\u003C 40 kg\u002Fm2.\n\nExclusion Criteria:\n\n1. Pregnant;\n2. Pre-existing sore throat, or history of upper respiratory tract infection\u002F abnormalities, hypertension, chronic pain or anti-inflammatory drugs and antihypertensive treatment;\n3. Allergies to benzydamine hydrochloride;\n4. Symptomatic hiatus hernia;\n5. Severe gastroesophageal reflux disease;\n6. Contraindications to the use of LMA.","FEMALE","21 Years","80 Years",{"count":58,"type":59},106,"ESTIMATED","INTERVENTIONAL",[62],"EARLY_PHASE1","Postoperative sore throat (POST) after laryngeal mask airway (LMA) insertion is prevalent and unappealing. A significant cause of POST is mechanical injury to the airway mucosa during airway instrumentation, leading to mucosal injury and inflammation. The Difflam Forte Anti-Inflammatory Throat Spray (Difflam) contains benzydamine hydrochloride, a non-steroidal anti-inflammatory agent with topical analgesic properties. This study will randomize 106 women undergoing gynaecological surgery under general anaesthesia with LMA use at KK Women's and Children's Hospital (KKH) in 1:1 allocation ratio of study (Difflam spray) and control (usual practice; no intervention) groups. Demographic and intraoperative airway data collection will be conducted in perioperative period. Those allocated to study group will receive Difflam spray when awake in the post-anaesthesia care unit (PACU). The primary aim to determine if patients undergoing general anaesthesia with LMA use with the Difflam spray in PACU will have a lower incidence of POST in the immediate and 4 hours postoperative recovery period, as compared with those in the control group. Other outcome measures include the severity of pain of sore throat as measured by the visual analog scale, and incidence of side effects associated with the Difflam spray. This proposal will determine whether the use of Difflam spray is suitable to be implemented in local clinical setting and improve perioperative care.",[65,66],"Sore Throat","Postoperative Care",[68,69,70,71],"Sore throat","Posoperative care","benzydamine hydrochloride","laryngeal mask airway","NOT_YET_RECRUITING","2025-04-15",{"date":75,"type":76},"2025-04-17","ACTUAL",{"date":78,"type":59},"2025-04",{"date":80,"type":59},"2026-12",{"name":5,"class":6},1]