protocolSection identificationModule nctId: NCT06275698, orgStudyIdInfo id: RD2023-14 HONEY-POT, secondaryIdInfos id: 323188, type: OTHER, domain: IRAS, secondaryIdInfos id: 56974, type: OTHER_GRANT, domain: CPMS, briefTitle: HONEY for the Treatment of POst-Tonsillectomy Pain, acronym: HONEY-POT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2025-09-04, completionDateStruct date: 2025-09-04, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: East and North Hertfordshire NHS Trust, class: OTHER_GOV, collaborators name: Manuka Doctor UK Ltd, collaborators name: National Institute for Health Research, United Kingdom, descriptionModule briefSummary: Double-blind, randomised, placebo controlled, single-site trial in adults to compare the effect of Manuka honey with standard of care compared to placebo with standard of care on post-tonsillectomy pain and postoperative outcomes.Main aim is to investigate a potential improvement in post-tonsillectomy pain control, with a low cost and freely available alternative to conventional analgesics. Recent systematic review and multidisciplinary consensus suggest a potential role for the inclusion of honey for this purpose. Clinical efficacy over placebo remains to be conclusively demonstrated in robust clinical trials., conditionsModule conditions: Post Surgical Pain, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention arm - Manuka honey, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy.Placebo - sugar-based syrup, thickened with sodium alginate and with honey flavouring, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Intervention (Manuka honey) and placebo will be supplied in identical opaque jars with identical labels apart from individual unique ID numbers to facilitate un-blinding in the case of adverse events.Neither the patient nor the researcher collecting data will be aware of which arm the patient has been enrolled onto., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Manuka honey MGO 1000, interventions name: Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring, outcomesModule primaryOutcomes measure: VAS pain scores, secondaryOutcomes measure: Number and frequency of concurrent analgesia usage, secondaryOutcomes measure: Rate of readmission to hospital, secondaryOutcomes measure: Rate of secondary haemorrhage, secondaryOutcomes measure: Rate of infection requiring antibiotics treatment, secondaryOutcomes measure: Speed of return to work, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lister Hospital, status: RECRUITING, city: Stevenage, zip: SG1 4AB, country: United Kingdom, contacts name: Toral Odedra, role: CONTACT, phone: 07918 360 060, email: toral.odedra@nhs.net, geoPoint lat: 51.90224, lon: -0.20256, hasResults: False