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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06275698
Other study ID # RD2023-14 HONEY-POT
Secondary ID 32318856974
Status Recruiting
Phase N/A
First received
Last updated
Start date September 4, 2023
Est. completion date September 4, 2025

Study information

Verified date February 2024
Source East and North Hertfordshire NHS Trust
Contact Carina Cruz
Phone 07917534555
Email carina.cruz@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Tonsillectomy is one of the most common surgical procedures performed in the UK. It can be a painful operation to recover from, particularly in adults. Amongst the recognised complications, poor oral intake secondary to uncontrolled pain can result in re-admission to hospital, development of localized infection and subsequent bleeding. Post-operative analgesia regimes can vary depending on the individual surgeon preference or departmental policies, however generally it involves regular simple analgesics including paracetamol, ibuprofen and topical analgesic throat sprays or rinses. Commonly, opioid based analgesics such as codeine, tramadol and oramorph are needed in the post-operative period. Whilst these are generally effective, they can be associated with significant side effects such as constipation, drowsiness and nausea and prolonged use is not recommended. Beehive products such as honey and propolis have been mentioned as wound dressings in ancient writings across the world, thousands of years before the advent of modern medicine. Honey is a by-product of flower nectar produced in the aero-digestive tract of bees and propolis is produced from plant resins, enriched with salivary enzymatic secretions. Honey has been shown to possess anti-bacterial and anti-inflammatory properties. Manuka honey is a mono-floral honey with potential wound repair and antibacterial activities. It is produced by bees fed on the flowers of the New Zealand Manuka bush (Leptospermum scoparium) and contains a significantly higher concentration of the 1,2-dicarbonyl compound methylglyoxal, which may account for its antibacterial activity. Manuka honey has been reported to stimulate the formation of new blood capillaries and the growth of fibroblasts and epithelial cells when applied topically to wounds. It is now part of the routine armamentarium of products used in the treatment of burns and external skin wounds in NHS Plastic surgery departments in the United Kingdom (UK). The clinical efficacy of Manuka honey in the oral and oropharyngeal cavities is controversial and quality, placebo controlled, randomized clinical trials are lacking. There are a number of systematic reviews that have described some benefit of Manuka honey in the treatment of radiation induced oro-mucositis, particularly in reducing treatment interruptions, preventing weight loss and pain control. The most recent PROSPECT (Procedure-specific postoperative pain management) guideline for tonsillectomy published in 2021 in the Anaesthesia journal, represented an international, multidisciplinary collaborative effort providing recommendations on the most effective pain management following tonsillectomy. The fourth of five summative recommendations, based on systematic review of the current literature, is that analgesic adjuncts such as postoperative honey is recommended. Honey could provide significant improvements in post-operative pain scores as well as provide opioid-sparing benefits. This is a powerful mandate for further research into the routine clinical usage of honey as an adjunct to post-tonsillectomy pain management. To date there have not been any placebo controlled, randomised clinical trials comparing the effectiveness of oral honey in post-tonsillectomy pain control in the UK. The aim of this double-blind, randomised, placebo controlled clinical trial is 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. The hypothesis is that the addition of Manuka honey to standard of care will result in a significant reduction in post-tonsillectomy pain scores compared to the placebo control. The null hypothesis is that there is no significant difference between Manuka honey compared to placebo in post-tonsillectomy pain scores. The primary endpoint/outcome are daily pain scores measured via Visual Analogue Scale (VAS). This is a continuous variable, which will be measured and recorded three times a day, every day for the first 14 days post-tonsillectomy. The secondary endpoint/outcomes include the number and frequency of concurrent analgesia usage, the rate of readmission to hospital, the rate of secondary haemorrhage, the rate of infection requiring antibiotics treatment, the speed of return to work. These are a mixture of continuous and ordinal variables and will be collected retrospectively.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Manuka honey MGO 1000
Natural Manuka honey, produced in New Zealand. With MGO content = 1000.
Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring
Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring, 15ml, three times a day, for 14 days. To be kept on the tongue for at least 10 seconds prior to swallowing.

Locations

Country Name City State
United Kingdom Lister Hospital Stevenage

Sponsors (3)

Lead Sponsor Collaborator
East and North Hertfordshire NHS Trust Manuka Doctor UK Ltd, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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

Outcome

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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