HONEY for the Treatment of POst-Tonsillectomy Pain (HONEY-POT)

February 16, 2024 updated by: East and North Hertfordshire NHS Trust

HONEY for the Treatment of POst-Tonsillectomy Pain - a Double-blind, Randomised, Placebo Controlled, Single Site 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 <18years old
  • Adults unable to consent for themselves

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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
Natural Manuka honey, produced in New Zealand. With MGO content ≥ 1000.
Placebo Comparator: Placebo

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS pain scores
Time Frame: 14 days post-tonsillectomy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and frequency of concurrent analgesia usage
Time Frame: 14 days post-tonsillectomy
Patients will be asked record their analgesia administration at home.
14 days post-tonsillectomy
Rate of readmission to hospital
Time Frame: 14 days post-tonsillectomy
Retrospective record of re-admission rate
14 days post-tonsillectomy
Rate of secondary haemorrhage
Time Frame: 14 days post-tonsillectomy
Retrospective record of secondary haemorrhage rate, defined as any haemorrhage after 24hrs post surgery
14 days post-tonsillectomy
Rate of infection requiring antibiotics treatment
Time Frame: 14 days post-tonsillectomy
Retrospective record of any related infection requiring antibiotic treatment
14 days post-tonsillectomy
Speed of return to work
Time Frame: 14 days post-tonsillectomy
Recording how quickly the patient is able to return to their normal occupation responsibilities
14 days post-tonsillectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East and North Hertfordshire NHS Trust

Collaborators

National Institute for Health Research, United Kingdom
Manuka Doctor UK Ltd

Investigators

  • Study Director: Phillip Smith, PhD, East and North Hertfordshire NHS Trust
  • Principal Investigator: George Mochloulis, MD, East and North Hertfordshire NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Estimated)

September 4, 2025

Study Completion (Estimated)

September 4, 2025

Study Registration Dates

First Submitted

August 24, 2023

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD2023-14 HONEY-POT
  • 323188 (Other Identifier: IRAS)
  • 56974 (Other Grant/Funding Number: CPMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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