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.