None listed
Conditions
Brief summary
Tonsillectomy is a very common surgery for children. Post-tonsillectomy there is a high rate of unplanned re-presentation to hospital with many of these visits due to pain. From recent work by our research team we know that despite being given pain medications on discharge, patients can experience insufficient pain management, perhaps in part due to misperceptions of parents regarding the safety of these analgesic medications. In this study we aim to assess the impact of honey on postoperative pain levels through a placebo-controlled trial. If honey is shown to be effective; then children will not only benefit from reduced pain but may also require less additional doses of strong pain killers. Furthermore, better pain control will reduce the number of re-presentations to their general practitioners or hospital benefiting the Health System as a whole.
Interventions
The standard treatment regime for discharge medication will be as per the institutional guidelines which are currently : Parents are given written instructions and advised that pain control is best achieved with regular paracetamol and ibuprofen for at least 5-7 days and then as required. If the combination of paracetamol and ibuprofen within one hour is not effective then oxycodone can be given for extra pain relief. Paracetamol: oral tablet/suspension, 15 mg/kg based on ideal body weight, patients advised to give regularly for at least 5 days every 4-6 hours. Ibuprofen: oral tablet/suspension, 10 mg/kg. Parents advised to give regularly for at least the first five days, every 8 hours with no more than 3 doses in 24 hours. Oxycodone: oral tablet/solution, 1 week prescription, 6 hourly, 0.05 mg/kg Ondansetron: oral wafer 0.15 mg/kg After informed written parental consent, paediatric patients, aged 1-16 years, undergoing tonsillectomy surgery will be randomised to receive either standard treatment alone or standard treatment plus a placebo or standard treatment plus one of two honeys to be taken on the ward before discharge and for at least 7 days post-discharge. The honeys are: Marri Honey Western Australia Manuka Honey The placebo is a sugar syrup and have the following ingredients: Queen Glucose Syrup: Glucose syrup (derived from corn), sulphur dioxide. It is gluten free, egg free, peanut free, soy free and vegan. Pure Harvest Organic Rice Malt Syrup: organic brown rice No additives or preservatives, gluten free, Vegan, GMO free, no artificial colours or flavours. PharmAust Syrup BP: sucrose, water, methyl hydroxybenzoate Each child in the honey / placebo groups will have a dosing regimen of 5 ml of honey or 5 ml of placebo regularly six times a day, if possible 30 minutes prior to eating. E.g. single dose will be given 30 minutes prior to a morning snack, an evening snack and mealtimes with the final dose being given before bedtime before brushing their teeth. In hospital, parents will be instructed to give honey at the same times as for post-discharge i.e. before breakfast, morning snack, lunch, afternoon snack, dinner and at night. The duration of honey dosing in hospital on the day of surgery will therefore depend on the time of surgery. Participants will be supplied with 1 kg of honey/placebo and instructed to take it on the day or surgery and continue for 7 more days. They may continue to take the honey/placebo for more than 7 days if a parent feels that their child is benefiting from it. Parents are instructed to dispose of the honey/placebo once they do not require it anymore. Adherence to the intervention will be monitored by a participant diary and follow-up either by text message or phone by the research team
Sponsors
Study design
Eligibility
Inclusion criteria
Children and young adults aged 1 to 16 years undergoing elective tonsillectomy procedures under general anaesthesia.
Exclusion criteria
Less than 1 year of age Contraindication to honey, or placebo ingredients e.g. known allergy to honey or sugars, and children with diabetes