HONEY for the Treatment of POst-Tonsillectomy Pain
HONEY for the Treatment of POst-Tonsillectomy Pain - a Double-blind, Randomised, Placebo Controlled, Single Site Trial
East and North Hertfordshire NHS Trust
100 participants
Sep 4, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria16
- 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
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Interventions
Natural Manuka honey, produced in New Zealand. With MGO content ≥ 1000.
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(1)
View Full Details on ClinicalTrials.gov
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NCT06275698