HONEY for the Treatment of POst-Tonsillectomy Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEast and North Hertfordshire NHS Trust
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult (≥18years old at the time of giving consent)
Consented and listed for bilateral tonsillectomy or adenotonsillectomy
Tonsillectomy performed within the trial study period
Disqualifiers
Any concurrent Head & Neck (H&N) malignancy
Unilateral tonsillectomy
Pregnancy
Concurrent pharyngeal or upper aerodigestive tract biopsy
Trial design
Design model
Parallel
Treatments tested in this trial
Manuka honey MGO 1000
Dietary supplementNatural Manuka honey, produced in New Zealand. With MGO content ≥ 1000.
Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring
Dietary supplementSugar-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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
14 days post-tonsillectomySecondary outcomes
1
Number and frequency of concurrent analgesia usage
Patients will be asked record their analgesia administration at home.
Time frame
14 days post-tonsillectomy2
Rate of readmission to hospital
Retrospective record of re-admission rate
Time frame
14 days post-tonsillectomy3
Rate of secondary haemorrhage
Retrospective record of secondary haemorrhage rate, defined as any haemorrhage after 24hrs post surgery
Time frame
14 days post-tonsillectomy4
Rate of infection requiring antibiotics treatment
Retrospective record of any related infection requiring antibiotic treatment
Time frame
14 days post-tonsillectomySponsors and contacts
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Source ClinicalTrials.gov