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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
Date results information 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] 288399 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Hospitalisation Behaviour Change 297406 0
Condition category
Condition code
Anaesthesiology 297594 297594 0 0
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] 293708 0
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] 297137 0
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] 297137 0
Day 3, 14 and 28 post procedure
Primary outcome [2] 297138 0
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] 297138 0
Day 3, 14 and 28 post procedure
Secondary outcome [1] 320133 0
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] 320133 0
Immediately post procedure
Secondary outcome [2] 320134 0
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] 320134 0
Immediately post procedure
Secondary outcome [3] 320135 0
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] 320135 0
Immediately post procedure
Secondary outcome [4] 320136 0
Analgesic requirements in recovery. The recovery nurse will record any analgesia given on the post-operative medication chart.
Timepoint [4] 320136 0
From arrival in the recovery room until discharge to the day ward.
Secondary outcome [5] 320137 0
Time in recovery. The arrival and departure times from recovery are recorded on the hospital theatre computer system.
Timepoint [5] 320137 0
From arrival in the recovery room until discharge to the day ward.
Secondary outcome [6] 320138 0
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] 320138 0
Day 3, 14 and 28
Secondary outcome [7] 320139 0
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] 320139 0
Day 3, 14 and 28
Secondary outcome [8] 320140 0
General practitioner visits. A researcher will ask parents about any GP visits via telephone interview.
Timepoint [8] 320140 0
Day 3, 14 and 28
Secondary outcome [9] 320141 0
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] 320141 0
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?
No
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] 5118 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 12580 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 292749 0
Other Collaborative groups
Name [1] 292749 0
Australian and New Zealand College of Anaesthetists
Country [1] 292749 0
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] 291479 0
None
Name [1] 291479 0
Address [1] 291479 0
Country [1] 291479 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294236 0
Children's Health Queensland Hospital and Health Service Human Research and Ethics Committee (EC00175)
Ethics committee address [1] 294236 0
Level 7
Centre for Children's Health Research
62 Graham St
South Brisbane
QLD
4101
Ethics committee country [1] 294236 0
Australia
Date submitted for ethics approval [1] 294236 0
14/12/2015
Approval date [1] 294236 0
14/01/2016
Ethics approval number [1] 294236 0
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 62998 0
Dr Paul Lee-Archer
Address 62998 0
Clinical Directorate
Level 7
Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
QLD
4101
Country 62998 0
Australia
Phone 62998 0
+61 7 3068 3833
Fax 62998 0
Email 62998 0
[email protected]
Contact person for public queries
Name 62999 0
Dr Paul Lee-Archer
Address 62999 0
Clinical Directorate
Level 7
Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
QLD
4101
Country 62999 0
Australia
Phone 62999 0
+61 7 3068 3833
Fax 62999 0
Email 62999 0
[email protected]
Contact person for scientific queries
Name 63000 0
Dr Paul Lee-Archer
Address 63000 0
Clinical Directorate
Level 7
Lady Cilento Children's Hospital
501 Stanley St
South Brisbane
QLD
4101
Country 63000 0
Australia
Phone 63000 0
+61 7 3068 3833
Fax 63000 0
Email 63000 0
[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.TypeCitationLinkEmailOther DetailsAttachment
6708Study protocolLee-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
SourceTitleYear of PublicationDOI
EmbaseDoes 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.2018https://dx.doi.org/10.1136/bmjopen-2017-019915
N.B. These documents automatically identified may not have been verified by the study sponsor.