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Trial registered on ANZCTR

Registration number

ACTRN12616000096459

Ethics application status

Approved

Date submitted

22/01/2016

Date registered

29/01/2016

Date last updated

3/02/2020

Date data sharing statement initially provided

3/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of dexmedetomidine given as a premedication or intraoperatively on post-hospitalisation behavioural change in children: a randomised controlled trial

Scientific title

The effect of dexmedetomidine given as a premedication or intraoperatively on post-hospitalisation behavioural change in children: a randomised controlled trial

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post Hospitalisation Behaviour Change

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

There will be two intervention groups: One group will be randomised to receive dexmedetomidine preoperatively 45 minutes prior to theatre (2 micrograms/kg made up to 1 mL with saline intranasally) and then after induction of anaesthesia they will receive an infusion of saline (1mL/kg) over ten minutes intravenously. The other group will receive a 1mL saline nasal spray 45 minutes prior to theatre and then after induction of anaesthesia they will receive a dexmedetomidine infusion 1mL/kg of 1microgram/mL solution over ten minutes intravenously. The nurse administering the premedication and the anaesthetist administering the infusion will be blinded to group allocation and the solutions will be made to look identical by a clinical trials pharmacist. The timing of administration will be recorded on the medication chart of the patient to monitor adherence.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

A third group will act as a control group and they will receive 1mL of saline intranasally 45 minutes prior to theatre and then after induction of anaesthesia they will receive an infusion of saline (1mL/kg) over ten minutes intravenously.

Control group

Placebo

Outcomes

Primary outcome [1]

Negative behaviours as measured by the Post Hospitalisation Behaviour Questionnaire for Ambulatory Surgery. This validated instrument is an 11 item parental report measure. It will be administered by a researcher to a parent via telephone interview on day 3, 14 and 28 post procedure.

Timepoint [1]

Day 3, 14 and 28 post procedure

Primary outcome [2]

Negative behaviours as measured by the Strength and Difficulties Questionnaire. This is a validated behaviour screening tool for children aged 2 to 16. It has 25 items on 5 scales and will be administered by a researcher to a parent via telephone interview on day 3, 14 and 28 post procedure.

Timepoint [2]

Day 3, 14 and 28 post procedure

Secondary outcome [1]

Emergence delirium. This will be measured using the Cornell Assessment of Paediatric Delirium (CAP-D). This scale has been designed to detect hypoactive, hyperactive and mixed delirium in children.

Timepoint [1]

Immediately post procedure

Secondary outcome [2]

Adverse effects. Common adverse effects of dexmedetomidine include bradycardia and hypotension. These will be assessed and recorded by the recovery nurse by the pulse rate on the pulse oximeter and non-invasive blood pressure measurement.

Timepoint [2]

Immediately post procedure

Secondary outcome [3]

Pain in recovery. This will be assessed using the Faces, Legs, Activity, Cry, Consolability (FLACC) Scale by the recovery nurse. This validated pain measurement tool is commonly used for children aged 2 months to 7 years.

Timepoint [3]

Immediately post procedure

Secondary outcome [4]

Analgesic requirements in recovery. The recovery nurse will record any analgesia given on the post-operative medication chart.

Timepoint [4]

From arrival in the recovery room until discharge to the day ward.

Secondary outcome [5]

Time in recovery. The arrival and departure times from recovery are recorded on the hospital theatre computer system.

Timepoint [5]

From arrival in the recovery room until discharge to the day ward.

Secondary outcome [6]

Pain at home. This will be assessed by a numeric rating scale (NRS) where a researcher will ask a parent via telephone which whole number from 0 to 10 best reflects the intensity of their child's pain with 0 being no pain and 10 the worst pain imaginable.

Timepoint [6]

Day 3, 14 and 28

Secondary outcome [7]

Parental days off work. A researcher will ask the parents about any days off work taken to care for their child via telephone interview.

Timepoint [7]

Day 3, 14 and 28

Secondary outcome [8]

General practitioner visits. A researcher will ask parents about any GP visits via telephone interview.

Timepoint [8]

Day 3, 14 and 28

Secondary outcome [9]

Parental satisfaction. This will be assessed by a researcher asking a parent via telephone interview to rate their overall satisfaction with their child's anaesthetic on a 5 -point Likert scale.

Timepoint [9]

Day 3, 14 and 28

Eligibility

Key inclusion criteria

Age 2 to 7 inclusive
Having day case surgical procedure
ASA 1 or 2

Minimum age

2 Years

Maximum age

7 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Emergency surgery
Allergy to dexmedetomidine
Currently taking antihypertensive medication
Existing behavioural problems/Attention Deficit Hyperactivity Disorder (ADHD) - defined as being under the care of a paediatrician for behavioural problems or currently taking medication for behavioural issues/ADHD

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)

The researcher who determines eligibility and obtains consent will be unaware of group allocation. Randomistaion will be performed in a 1:1:1 ratio and allocation concealment will be via the use of sequentially numbered, sealed opaque envelopes prepared by a third party.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be generated by a randomisation application that uses a computer generated sequence allocation.

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

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Baseline characteristics will be compared using student’s t-test for continuous variables and chi-squared analysis for categorical variables.

The chi-squared test will be used to compare changes in proportion of NBC over time.

Stepwise multiple binary logistic regression will be used to analyse relationships between baseline characteristics and NBC. Only independent predictor variables will be retained in the final model.

The sample size was calculated assuming an underlying rate of 50% of negative behaviour change on day 3 post procedure and a clinically significant reduction would be 50% to an overall rate of 25%. For a power of 90%, an alpha-error of 0.05 and assuming a 20% loss to follow-up we would need 98 patients per group.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2017

Actual

1/02/2017

Date of last participant enrolment

Anticipated

1/10/2017

Actual

10/11/2017

Date of last data collection

Anticipated

Actual

8/12/2017

Sample size

Target

294

Accrual to date

Final

248

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Lady Cilento Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Australian and New Zealand College of Anaesthetists

Address [1]

ANZCA House,
630 St Kilda Road,
Melbourne, Victoria 3004,
Australia.

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Paul Lee-Archer

Address

Clinical Directorate
Level 7
Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
QLD
4101

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Queensland Hospital and Health Service Human Research and Ethics Committee (EC00175)

Ethics committee address [1]

Level 7
Centre for Children's Health Research
62 Graham St
South Brisbane
QLD
4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/12/2015

Approval date [1]

14/01/2016

Ethics approval number [1]

HREC/15/QRCH/248

Summary

Brief summary

The aim of this project is to assess whether the administration of dexmedetomidine either before or during a child's operation affects the incidence of post-hospitalisation behavioural change (PHBC).  It has been reported that PHBC occurs in over 50% of children undergoing a general anaesthetic(1) and manifests as behaviours such as sleep and eating disorders, defiance of authority, nightmares, enuresis and temper tantrums.  The effect is usually short-lived, however in 5-10% of children these behaviours can last up to 12 months.  The risk factors for developing PHBC include underlying anxiety in the child or parent, a traumatic experience at induction of anaesthesia, emergence delirium and pre-school age.  A recent meta-analysis of alpha-2 agonists found that they effectively reduce the incidence of emergence delirium but none of the studies looked at longer term outcomes (2).  This study aims to answer the question of whether dexmedetomidine, an alpha-2 agonist, can reduce the incidence of PHBC.  

Pre-school age children requiring general anaesthesia for common day-case procedures will be randomly assigned to one of three groups: A dexmedetomidne pre-medication group, an intraoperative dexmedetomidine group and a control group.  Baseline anxiety levels of the child and parents will be recorded using validated tools and the anxiety of the child during induction of anaesthesia will also be recorded.

The primary outcome will be maladaptive behaviours after hospitalisation and these will be measured using the Post Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) and the Strengths and Difficulties Questionnaire (SDQ).  These questionnaires on children's behaviour will be administered to the parents by a blinded researcher at day 3, 14 and 28 post surgery.

1. Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children:Predictors and outcomes. Arch Pediatr Adolesc Med. 1996; 150:1238-45.
2. Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative a2-adrenergic agonists on postoperative behaviour in children. BJA. 2014; 112(6):982-90.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Paul Lee-Archer

Address

Clinical Directorate
Level 7
Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
QLD
4101

Country

Australia

Phone

+61 7 3068 3833

Fax

[email protected]

Contact person for public queries

Name

Paul Lee-Archer

Address

Clinical Directorate
Level 7
Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
QLD
4101

Country

Australia

Phone

+61 7 3068 3833

Fax

[email protected]

Contact person for scientific queries

Name

Paul Lee-Archer

Address

Clinical Directorate
Level 7
Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
QLD
4101

Country

Australia

Phone

+61 7 3068 3833

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Outcome data for primary and secondary outcomes

When will data be available (start and end dates)?

9.1.20 to 9.1.23

Available to whom?

Researchers interested in behavioural outcomes in children

Available for what types of analyses?

Systematic review and meta-analysis

How or where can data be obtained?

Contact author via email: [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6708	Study protocol	Lee-Archer P, McBride C, Paterson R, Reade M, Regli-von Ungern-Sternberg B, Long D. Does dexmedetomidine given as a premedication or intraoperatively reduce post-hospitalisation behaviour change in children? A study protocol for a randomised controlled trial in a tertiary paediatric hospital. BMJ Open. 2018, 8(4) e019915.

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Does dexmedetomidine given as a premedication or intraoperatively reduce post-hospitalisation behaviour change in children? A study protocol for a randomised controlled trial in a tertiary paediatric hospital.	2018	https://dx.doi.org/10.1136/bmjopen-2017-019915

N.B. These documents automatically identified may not have been verified by the study sponsor.

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