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NCT06275698
HONEY for the Treatment of POst-Tonsillectomy Pain
Conditions: Post Surgical Pain, Analgesia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 100
Sponsor: East and North Hertfordshire NHS Trust
Location: Lister Hospital Stevenage
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT06275698). StuddyBuddy aggregates publicly available trial information.