Analgesia Clinical Trial
— HONEY-POTOfficial title:
HONEY for the Treatment of POst-Tonsillectomy Pain - a Double-blind, Randomised, Placebo Controlled, Single Site Trial
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 4, 2025 |
Est. primary completion date | September 4, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult (=18years old at the time of giving consent) - Consented and listed for bilateral tonsillectomy or adenotonsillectomy - Tonsillectomy performed within the trial study period Exclusion Criteria: - Any concurrent Head & Neck (H&N) malignancy - Unilateral tonsillectomy - Pregnancy - Concurrent pharyngeal or upper aerodigestive tract biopsy - Robotic tonsillectomy - Previous H&N malignancy - Previous H&N radiotherapy - Type 1/2 diabetes mellitus - Known allergy to bee related products - Known allergy to golden syrup - History of chronic pain - History of fibromyalgia - Current usage of chronic (>6weeks) analgesia - High-risk anaesthetic patients - Children or adolescents <18years old - Adults unable to consent for themselves |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Lister Hospital | Stevenage |
Lead Sponsor | Collaborator |
---|---|
East and North Hertfordshire NHS Trust | Manuka Doctor UK Ltd, National Institute for Health Research, United Kingdom |
United Kingdom,
Aldamluji N, Burgess A, Pogatzki-Zahn E, Raeder J, Beloeil H; PROSPECT Working Group collaborators*. PROSPECT guideline for tonsillectomy: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Jul;76(7):947-961. doi: 10.1111/anae.15299. Epub 2020 Nov 17. — View Citation
Carter DA, Blair SE, Cokcetin NN, Bouzo D, Brooks P, Schothauer R, Harry EJ. Therapeutic Manuka Honey: No Longer So Alternative. Front Microbiol. 2016 Apr 20;7:569. doi: 10.3389/fmicb.2016.00569. eCollection 2016. — View Citation
Cho HK, Jeong YM, Lee HS, Lee YJ, Hwang SH. Effects of honey on oral mucositis in patients with head and neck cancer: A meta-analysis. Laryngoscope. 2015 Sep;125(9):2085-92. doi: 10.1002/lary.25233. Epub 2015 Mar 16. — View Citation
Hawley P, Hovan A, McGahan CE, Saunders D. A randomized placebo-controlled trial of manuka honey for radiation-induced oral mucositis. Support Care Cancer. 2014 Mar;22(3):751-61. doi: 10.1007/s00520-013-2031-0. Epub 2013 Nov 13. — View Citation
Nolan VC, Harrison J, Wright JEE, Cox JAG. Clinical Significance of Manuka and Medical-Grade Honey for Antibiotic-Resistant Infections: A Systematic Review. Antibiotics (Basel). 2020 Oct 31;9(11):766. doi: 10.3390/antibiotics9110766. — View Citation
Yang C, Gong G, Jin E, Han X, Zhuo Y, Yang S, Song B, Zhang Y, Piao C. Topical application of honey in the management of chemo/radiotherapy-induced oral mucositis: A systematic review and network meta-analysis. Int J Nurs Stud. 2019 Jan;89:80-87. doi: 10.1016/j.ijnurstu.2018.08.007. Epub 2018 Aug 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS pain scores | Pain scores as measured on a visual analogue scale 1-10.This is a continuous variable, which will be measured and recorded three times a day, every day for the first 14 days post-tonsillectomy. | 14 days post-tonsillectomy | |
Secondary | Number and frequency of concurrent analgesia usage | Patients will be asked record their analgesia administration at home. | 14 days post-tonsillectomy | |
Secondary | Rate of readmission to hospital | Retrospective record of re-admission rate | 14 days post-tonsillectomy | |
Secondary | Rate of secondary haemorrhage | Retrospective record of secondary haemorrhage rate, defined as any haemorrhage after 24hrs post surgery | 14 days post-tonsillectomy | |
Secondary | Rate of infection requiring antibiotics treatment | Retrospective record of any related infection requiring antibiotic treatment | 14 days post-tonsillectomy | |
Secondary | Speed of return to work | Recording how quickly the patient is able to return to their normal occupation responsibilities | 14 days post-tonsillectomy |
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