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Trial registered on ANZCTR
Registration number
ACTRN12619001385134
Ethics application status
Approved
Date submitted
6/09/2019
Date registered
10/10/2019
Date last updated
29/11/2021
Date data sharing statement initially provided
10/10/2019
Date results information initially provided
29/11/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Does oral honey decrease the incidence of postoperative pain in children undergoing tonsillectomy procedures? (Bee - pain free)
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Scientific title
A multi-centre, double-blinded, randomised controlled trial to investigate honey use to reduce pain in children post-tonsillectomy.
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Secondary ID [1]
299186
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NIL
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Universal Trial Number (UTN)
NIL
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Trial acronym
NIL
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Linked study record
NIL
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Health condition
Health condition(s) or problem(s) studied:
Pain following tonsillectomy surgery
314285
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Condition category
Condition code
Anaesthesiology
312635
312635
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0
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Pain management
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Oral and Gastrointestinal
313089
313089
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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
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Intervention code [1]
315481
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Treatment: Other
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Comparator / control treatment
There are 4 arms in the study:
1-standard treatment alone (control arm)
2-standard treatment plus placebo (sugar syrup) (control arm)
3-standard treatment plus Marri Honey
4-standard treatment plus Western Australia Manuka Honey
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The primary outcome measure will be self-reported pain using the Faces Pain Scale -revised (FPS-R) assessed 4 times daily for 7 days postoperatively. The pain intensity score for each discrete time point will be compared across groups at rest before breakfast and evening meals, and on swallowing during breakfast and evening meals
For children under 4 years of age, parents will be asked to rate their child's pain between 0 and 10 at rest and with swallowing.
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Assessment method [1]
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Timepoint [1]
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Assessed 4 times daily for 7 days after the surgery. (primary endpoint Day 7)
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Secondary outcome [1]
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Daily parents’ postoperative pain measure in the honey groups compared to placebo and control groups over study period.
Parents will be relate their "Parents' Postoperative Pain Measure" (PPPM) scores for each post-operative day which . This information will be collected from parents during followup (parents choice of either phone call or text on each day).
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Assessment method [1]
374604
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Timepoint [1]
374604
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assessed daily for 7 days post-surgery.
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Secondary outcome [2]
374605
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Opioid analgesic intake-number of rescue doses received over 7 days between groups.
Assessed through parent reporting during follow-up.
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Assessment method [2]
374605
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Timepoint [2]
374605
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7 days after surgery
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Secondary outcome [3]
374606
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Number of episodes of vomiting reported by parents between groups.Assessed through parent reporting during follow-up.
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Assessment method [3]
374606
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Timepoint [3]
374606
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7 days after surgery
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Secondary outcome [4]
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Number of unplanned representations to GP/Emergency Department in the seven days post-tonsillectomy between groups. This outcome is assessed from parent reporting.
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Assessment method [4]
374607
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Timepoint [4]
374607
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7 days after surgery
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Secondary outcome [5]
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Opioid analgesic intake, measured as oral morphine equivalents received over 7 days between groups.Assessed through parent reporting during follow-up.
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Assessment method [5]
375387
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Timepoint [5]
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7 days post tonsillectomy
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Secondary outcome [6]
375388
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Number of incidences of nausea reported by parents between groups.Assessed through parent reporting during follow-up.
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Assessment method [6]
375388
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Timepoint [6]
375388
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7 days after surgery
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Secondary outcome [7]
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The acceptability of honey by parents, global satisfaction score, Parent reported, collected during followup.
This will be measured by the numerical rating scale NRS-11 between 0 and 10.
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Assessment method [7]
375389
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Timepoint [7]
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7 days after surgery
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Eligibility
Key inclusion criteria
Children and young adults aged 1 to 16 years undergoing elective tonsillectomy procedures under general anaesthesia.
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Minimum age
1
Years
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by numbered containers of honey/placebo syrup.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
Multicentre trial.
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The data will be analysed as a longitudinal model. The analysis will indicate any differences in the four treatments (peroxide honey, non-peroxide honey, placebo and standard care only) and the change in pain score over time (days). More specifically, the model will include the effect of treatment, and measurement condition (at rest or swallowing), both over time, a random intercept for subject (to account for different baseline pain scores), a subject-specific random slope for treatment, and other study measurements detailed above (such as demographic variables Age, ASA, etc.).
Note that the longitudinal nature of the model will allow missing responses at a few time points. If substantial pain measurement data is missing then a decision will be made either to omit the record from analysis, or to impute the data using a standard technique (such as multiple imputation based on chained equations).
The simulations were repeated with several different parameter values (in particular a range of values for the mean vector around the mean specified above), and a sample size of 85 per group was found to be sufficient. Simulations give a power of 0.9 for a sample size of 85 per group. The power for a corresponding Anova with 85 patients and same standard deviation is only 70%. 15 patients are added per group due to loss in follow-up, cancellation of surgery, change of surgical plan and other protocol violations.
Regarding secondary outcomes, these will be assessed as follows.
1. Daily pain score as reported by parents (PPPM) will be analysed as a repeated measures model between groups, as for the children’s pain scores.
2. The amount of oxycodone administered to each group over the days will be analysed as a repeated measures model.
3. The total number of presentations for each group and episodes of vomiting post discharge will be analysed as a Poisson log-linear model or a contingency table using a chi square test of association
4. The acceptability of honey by parents, global satisfaction score will be analysed as a contingency table using a chi square test of association, or as a binomial log-linear model.
Demographics (age, weight, ASA, length of stay and operation data) will be included in the statistical modelling. Summary statistics will also be presented to enable and simplify direct group comparisons.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
4/11/2019
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Actual
12/11/2019
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Date of last participant enrolment
Anticipated
31/07/2021
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Actual
21/07/2021
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Date of last data collection
Anticipated
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Actual
3/08/2021
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Sample size
Target
400
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Accrual to date
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Final
400
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Perth Children's Hospital - Nedlands
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Recruitment hospital [2]
14733
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Subiaco Private Hospital - Subiaco
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Recruitment hospital [3]
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St John of God Hospital, Subiaco - Subiaco
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Recruitment hospital [4]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
27774
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6009 - Nedlands
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Recruitment postcode(s) [2]
27775
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6008 - Subiaco
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Recruitment postcode(s) [3]
34039
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6008 - Subiaco
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Recruitment postcode(s) [4]
34040
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6150 - Murdoch
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Funding & Sponsors
Funding source category [1]
303726
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Charities/Societies/Foundations
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Name [1]
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Perth Children's Hospital Foundation
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Address [1]
303726
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Perth Children's Hospital
15 Hospital Avenue,
Nedlands
WA 6009
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Country [1]
303726
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Australia
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Funding source category [2]
303746
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Other Collaborative groups
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Name [2]
303746
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Cooperative Research Centre for Honey Bee Products (CRCHBP)
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Address [2]
303746
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University of Western Australia
Myers Building
M087,
Perth
WA 6009
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Country [2]
303746
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Australia
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Funding source category [3]
310266
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Government body
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Name [3]
310266
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Department of Health, Western Australia
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Address [3]
310266
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189 Royal St,
East Perth
WA 6004
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Country [3]
310266
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
Telethon Kids Institute
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Address
Northern Entrance,
Perth Children's Hospital,
15 Hospital Ave,
Nedlands
WA 6009
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Country
Australia
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Secondary sponsor category [1]
303865
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None
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Name [1]
303865
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Address [1]
303865
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Country [1]
303865
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304251
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Child and Adolescent Health Service Ethics Committee
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Ethics committee address [1]
304251
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Level 5,
Perth Children’s Hospital
15 Hospital Avenue
Nedlands
WA 6009
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Ethics committee country [1]
304251
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Australia
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Date submitted for ethics approval [1]
304251
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20/05/2019
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Approval date [1]
304251
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19/09/2019
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Ethics approval number [1]
304251
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RGS0000003325
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Summary
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.
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Trial website
NIL
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Trial related presentations / publications
NIL
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Public notes
NIL
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Contacts
Principal investigator
Name
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Prof Britta Regli-von Ungern-Sternberg
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Address
96290
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Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
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Country
96290
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Australia
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Phone
96290
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+61420790101
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Fax
96290
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Email
96290
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[email protected]
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Contact person for public queries
Name
96291
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Prof Britta Regli-von Ungern-Sternberg
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Address
96291
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Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
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Country
96291
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Australia
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Phone
96291
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+61420790101
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Fax
96291
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Email
96291
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[email protected]
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Contact person for scientific queries
Name
96292
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Prof Britta Regli-von Ungern-Sternberg
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Address
96292
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Perth Children's Hospital
15 Hospital Avenue
Nedlands
WA 6009
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Country
96292
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Australia
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Phone
96292
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+61420790101
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Fax
96292
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Email
96292
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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