ANZCTR - Registration

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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 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]

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.

Blood sugar control

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Surgery

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]

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]

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]

Whilst the patient is in recovery, at 30 minutes intervals until patient is discharged from hospital.

Primary outcome [2]

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]

Whilst the patient is in recovery, until patient is discharged from hospital.

Primary outcome [3]

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]

Whilst the patient is in recovery, at 30 minutes intervals until patient is discharged from hospital.

Secondary outcome [1]

Time to discharge. This will be prospectively collected from the hospital records.

Timepoint [1]

Measured from when the patient reaches the recovery room till when they are discharged home

Secondary outcome [2]

Blood glucose. Obtained via capillary (finger-prick) blood sample measured by a glucose meter.

Timepoint [2]

After induction of anaesthesia prior to administration of IV fluids.

Secondary outcome [3]

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]

Measured at the time of discharge and 24 hours after discharge.

Secondary outcome [4]

Blood ketones. Obtained via capillary (finger-prick) blood sample measured by a ketone meter.

Timepoint [4]

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?

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]

Monash Children’s Hospital - Clayton

Recruitment postcode(s) [1]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Monash Children's Hospital

Address [1]

246 Clayton Road Clayton, VIC 3168

Country [1]

Australia

Primary sponsor type

Hospital

Name

Monash Children's Hospital

Address

246 Clayton Road,
Clayton, VIC 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Health Human Research Ethics Committee

Ethics committee address [1]

Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/09/2018

Approval date [1]

16/10/2018

Ethics approval number [1]

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

Mr Maurizio Pacilli, MBBS (Hons), MS (Res), FRCS (Paed. Surg)

Address

Department of Paediatric General Surgery Level 5, Monash Children's Hospital Monash Health 246 Clayton Road, Clayton VIC 3168

Country

Australia

Phone

+61385723837

Fax

[email protected]

Contact person for public queries

Name

Ashleigh Laird, MBBS student Monash University

Address

Surgical Simulation Centre Level 3, Monash Children's Hospital Monash Health 246 Clayton Road, Clayton VIC 3168

Country

Australia

Phone

+61385723837

Fax

[email protected]

Contact person for scientific queries

Name

Maurizio Pacilli, MBBS (Hons), MS (Res), FRCS (Paed. Surg)

Address

Department of Paediatric General Surgery Level 5, Monash Children's Hospital Monash Health 246 Clayton Road, Clayton VIC 3168

Country

Australia

Phone

+61385723837

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Currently analysing data

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effects of a Preoperative Carbohydrate Load on Postoperative Recovery in Children: A Randomised, Double-Blind, Placebo-Controlled Trial.	2023	https://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.

Trial Review

Documents added manually

Documents added automatically