Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001527257
Ethics application status
Approved
Date submitted
7/09/2018
Date registered
12/09/2018
Date last updated
18/02/2020
Date data sharing statement initially provided
24/07/2019
Date results information initially provided
18/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a preoperative carbohydrate drink on postoperative recovery after day-surgery in children; The Sweet Dreams Trial.
Scientific title
Effects of a preoperative carbohydrate drink on postoperative recovery after day-surgery in children: a randomised double-blind, placebo-controlled trial
Secondary ID [1] 295719 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative recovery following general anesthesia and day surgery. 309221 0
Blood sugar control 309227 0
Condition category
Condition code
Anaesthesiology 307992 307992 0 0
Other anaesthesiology
Surgery 308419 308419 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a carbohydrate-containing drink mixed with water and sugar-free flavoured cordial. The volume will be dependent on the child's age. The drink will be given 2 hours prior to induction of the general anaesthetic. The carbohydrate load will be calculated based on the child age: 45 grams for 4-7 years old in 200mL of water; 55 grams for 8-11 years old in 250mL of water; 70 grams for 12-15 years old in 300mL of water. The drink will be made up by the trial dietitians and administered by the trial coordinator. This change was made prior to the enrolment of any participants.
Intervention code [1] 302042 0
Treatment: Other
Comparator / control treatment
The control group will receive a sugar-free flavoured cordial mixed with water, The volume will be dependent on the child's age. This will be given 2 hours prior to the induction of the general anaesthetic. This will act as the placebo, being carbohydrate free. Drinks for the treatment and placebo group will look and taste the same. The drink will be made up by the trial dietitians and administered by the trial coordinator.
Control group
Placebo

Outcomes
Primary outcome [1] 306968 0
This is a composite primary outcome.
Post-operative pain;
Assessed using the validated Wong-Baker Faces Pain Rating Scale (0-10)
0 = No pain
10 = Severe pain

And a Behavioural scale (FLACC scale - Face, legs, activity, cry, consolability)
Scored from 0-10
Face
0 = No particular expression or smile
1 = Occasional grimace or frown, withdrawn, disinterested
2 = Frequent to constant frown, quivering chin, clenched jaw
Legs
0 = Normal position or relaxed
1 = Uneasy, restless, tense
2 = Kicking or legs drawn up
Activity
0 = Lying quietly, normal position, moves easily
1 = Squirming, shifting back and forth, tense
2 = Arched, rigid, or jerking
Cry
0 = No cry (awake or asleep)
1 = Moans or whimpers, occasional complaint
2 = Crying steadily, screams or sobs, frequent complaints
Consolability
0 = Content, relaxed
1 = Reassured by occasional touching, hugging, or being talked to; distractile
2 = Difficult to console or comfort
Timepoint [1] 306968 0
Whilst the patient is in recovery, at 30 minutes intervals until patient is discharged from hospital.
Primary outcome [2] 306969 0
This is a composite primary outcome.
Analgesic and anti-emetic medications requirement and number of post-operative vomits.
These outcomes will be prospectively collected from the hospital records.
Timepoint [2] 306969 0
Whilst the patient is in recovery, until patient is discharged from hospital.
Primary outcome [3] 306970 0
This is a composite primary outcome.
Post-operative nausea
Assessed using a validated visual analogue scale (0-10 score);
0 = no nausea
10 = extreme nausea

And a 4-point verbal descriptive scale
0 = no nausea
1 = mild
2 = moderate
3 = severe
Timepoint [3] 306970 0
Whilst the patient is in recovery, at 30 minutes intervals until patient is discharged from hospital.
Secondary outcome [1] 350288 0
Time to discharge. This will be prospectively collected from the hospital records.
Timepoint [1] 350288 0
Measured from when the patient reaches the recovery room till when they are discharged home
Secondary outcome [2] 350289 0
Blood glucose.
Obtained via capillary (finger-prick) blood sample measured by a glucose meter.
Timepoint [2] 350289 0
After induction of anaesthesia prior to administration of IV fluids.
Secondary outcome [3] 351677 0
Post-operative wellbeing measured using an irritability questionnaire completed by the parents. The questionnaire was adapted from the validated Swanson, Nolan and Pelham (SNAP) Questionnaire (Swanson et al, 1983).
Timepoint [3] 351677 0
Measured at the time of discharge and 24 hours after discharge.
Secondary outcome [4] 351739 0
Blood ketones.
Obtained via capillary (finger-prick) blood sample measured by a ketone meter.
Timepoint [4] 351739 0
After induction of anaesthesia prior to administration of IV fluids.

Eligibility
Key inclusion criteria
1. Children aged 4 years to 15 years
2. Undergoing a day procedure
3. With no significant associated comorbidities (American Society of Anaesthesiologists Classification of Physical Status [ASA] Grade 1)
Minimum age
4 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Metabolic conditions (e.g patients with diabetes, on a ketogenic diet or with conditions impairing gastric emptying such as gastro-oesophageal reflux)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a double-blinded, randomised controlled trial.
Patients - The intervention and placebo drinks are designed to look and taste the same. Patients are not told which drink they have been given.
Investigators - Both drinks are prepared by a third party (i.e. the dietetics department). The drinks are labelled identically in numbered containers such that patinets and the investigators are unaware of the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Weighted minimisation using a computer program.
Minimisation criteria:
Age
Weight
Gender
Surgical procedure
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Results will be analysed accordingly after data extraction with dedicated statistical software (GraphPad Prism 7, MedCalc 18). Data will be expressed as mean ± SD, median (range), interquartile range (IQR), count number, or percentages, as indicated. The D’Agostino and Pearson normality test will be used to evaluate the normal distribution of continuous variables. Unpaired Student’s t, Mann–Whitney U, Chi-squares, or Fischer’s exact test will be used where appropriate to identify differences between the two groups for continuous or categorical variables. Sub-analysis for duration of anaesthesia and different types of surgical procedures will be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2019
Actual
13/03/2019
Date of last participant enrolment
Anticipated
1/12/2019
Actual
13/02/2020
Date of last data collection
Anticipated
3/12/2019
Actual
13/02/2020
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11559 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 23603 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 300311 0
Hospital
Name [1] 300311 0
Monash Children's Hospital
Country [1] 300311 0
Australia
Primary sponsor type
Hospital
Name
Monash Children's Hospital
Address
246 Clayton Road,
Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 299742 0
None
Name [1] 299742 0
Address [1] 299742 0
Country [1] 299742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301122 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 301122 0
Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Australia
Ethics committee country [1] 301122 0
Australia
Date submitted for ethics approval [1] 301122 0
19/09/2018
Approval date [1] 301122 0
16/10/2018
Ethics approval number [1] 301122 0
HREC/44496/MonH-2018-153063(v1)

Summary
Brief summary
A recent study has shown that pre-operative carbohydrate loading in adults undergoing laparoscopic surgery can reduce symptoms of nausea, vomiting and pain. A similar trial on the effect of pre-operative carbohydrate loading in children has not been conducted. Our trial aims to determine if pre-operative carbohydrate loading in children has a positive effect on post-operative recovery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85930 0
Mr Maurizio Pacilli, MBBS (Hons), MS (Res), FRCS (Paed. Surg)
Address 85930 0
Department of Paediatric General Surgery
Level 5, Monash Children's Hospital
Monash Health
246 Clayton Road, Clayton VIC 3168
Country 85930 0
Australia
Phone 85930 0
+61385723837
Fax 85930 0
Email 85930 0
maurizio.pacilli@monash.edu
Contact person for public queries
Name 85931 0
Ashleigh Laird, MBBS student Monash University
Address 85931 0
Surgical Simulation Centre
Level 3, Monash Children's Hospital
Monash Health
246 Clayton Road, Clayton VIC 3168
Country 85931 0
Australia
Phone 85931 0
+61385723837
Fax 85931 0
Email 85931 0
ajlai3@student.monash.edu
Contact person for scientific queries
Name 85932 0
Maurizio Pacilli, MBBS (Hons), MS (Res), FRCS (Paed. Surg)
Address 85932 0
Department of Paediatric General Surgery
Level 5, Monash Children's Hospital
Monash Health
246 Clayton Road, Clayton VIC 3168
Country 85932 0
Australia
Phone 85932 0
+61385723837
Fax 85932 0
Email 85932 0
maurizio.pacilli@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Currently analysing data

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of a Preoperative Carbohydrate Load on Postoperative Recovery in Children: A Randomised, Double-Blind, Placebo-Controlled Trial.2023https://dx.doi.org/10.1016/j.jpedsurg.2023.05.004
N.B. These documents automatically identified may not have been verified by the study sponsor.