HONEY for the Treatment of POst-Tonsillectomy Pain

NCT06275698 | Recruiting DMC

• 3 other identifiers: RD2023-14 HONEY-POT32318856974
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Surgical Pain; Analgesia

Keywords

Post-tonsillectomy pain; Tonsil surgery; Manuka honey; Honey

Outcome Measures

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.

  14 days post-tonsillectomy

Secondary Outcomes (5)

• Number and frequency of concurrent analgesia usage

  14 days post-tonsillectomy

• Rate of readmission to hospital

  14 days post-tonsillectomy

• Rate of secondary haemorrhage

  14 days post-tonsillectomy

• Rate of infection requiring antibiotics treatment

  14 days post-tonsillectomy

• Speed of return to work

  14 days post-tonsillectomy

Study Arms (2)

Treatment

EXPERIMENTAL

Manuka honey, 15ml, three times a day, for 14 days. To be kept on the tongue for at least 10 seconds prior to swallowing.

Dietary Supplement: Manuka honey MGO 1000

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring

Interventions

Manuka honey MGO 1000 DIETARY_SUPPLEMENT

Natural Manuka honey, produced in New Zealand. With MGO content ≥ 1000.

Treatment

Sugar-based syrup, thickened with sodium alginate and flavoured with honey flavouring DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18years old at the time of giving consent)
• Consented and listed for bilateral tonsillectomy or adenotonsillectomy
• Tonsillectomy performed within the trial study period

You may not qualify if:

• 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

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead
• Manuka Doctor UK Ltd: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Lister Hospital

Stevenage, SG1 4AB, United Kingdom

RECRUITING

Related 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.

  PMID: 33201518 BACKGROUND

• 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.

  PMID: 33142845 BACKGROUND

• 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.

  PMID: 27148246 BACKGROUND

• 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.

  PMID: 24221577 BACKGROUND

• 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.

  PMID: 30352321 BACKGROUND

• 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.

  PMID: 25778825 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Alginates; Flavoring Agents

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates; Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Phillip Smith, PhD

  East and North Hertfordshire NHS Trust

  STUDY DIRECTOR

• George Mochloulis, MD

  East and North Hertfordshire NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina Cruz

CONTACT

07917534555; carina.cruz@nhs.net

Toral Odedra

CONTACT

07918 360 060; toral.odedra@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Intervention (Manuka honey) and placebo will be supplied in identical opaque jars with identical labels apart from individual unique ID numbers to facilitate un-blinding in the case of adverse events. Neither the patient nor the researcher collecting data will be aware of which arm the patient has been enrolled onto.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Intervention arm - Manuka honey, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy. Placebo - sugar-based syrup, thickened with sodium alginate and with honey flavouring, to be taken per-oral 15ml TDS for 14 days post-tonsillectomy.

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: February 23, 2024
• Study Start: September 4, 2023
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)