Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001459112
Ethics application status
Approved
Date submitted
12/10/2019
Date registered
22/10/2019
Date last updated
22/08/2022
Date data sharing statement initially provided
22/10/2019
Date results information initially provided
22/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
How Intraoperative pain indices Predict Post-operative Outcomes in children younger than 2 years: HIPPO study
Scientific title
How Intraoperative pain Predicts Post-operative Outcomes in children: HIPPO study-
A prospective observational pilot study using newborn infant parasympathetic evaluation (NIPE)
Secondary ID [1] 299111 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain 314160 0
Condition category
Condition code
Anaesthesiology 312530 312530 0 0
Pain management
Surgery 312531 312531 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will undergo elective surgery according to local guidelines and practice (i.e. inguinal hernia repair, orchidopexy, patent processus vaginalis ligation for hydrocele, circumcision, umbilical hernia repair and excision of skin lesions).
The NIPE monitor will be connected to the electrocardiogram monitor, to analyse the heart rate variability (and thus parasympathetic tone), producing a value correlating to pain. We will be documenting the mean intraoperative NIPE value, as well as the absolute values at the following specified time points: endotracheal intubation, venous cannulation, peripheral nerve block administration, skin incision, and skin closure.
Following these procedures, post-operative outcomes will be assessed. Patients will be observed from entering the post anaesthetic care unit until discharge home or to the surgical ward.
Intervention code [1] 315378 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321173 0
Post-operative analgesic requirement.
This will be retrospectively collected from study-specific outcome questionnaires, or hospital records
Timepoint [1] 321173 0
Post-operative period until discharge from the post anaesthesia care unit
Primary outcome [2] 321660 0
Post-operative pain; assessed using the validated FLACC Behavioural scale:

Scored from 0-10, each component scored from 0-2
Face
0: No particular expression or smile
1: Occasional grimace or frown, withdrawn, disinterested
2: Frequent to constant 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; distractible
2: Difficult to console or comfort
Timepoint [2] 321660 0
Post-operative period until discharged from the post anaesthesia care unit, assessed at 30 minute intervals.
Secondary outcome [1] 374194 0
Post operative pain assessed using a numerical rating score (0-10), assessed by the parent or carer
Timepoint [1] 374194 0
At 60 minutes and 2 hours after the child enters the post anaesthesia care unit.
Secondary outcome [2] 375467 0
Post operative irritability assessed using a numerical rating score (0-10), assessed by the parent or carer
Timepoint [2] 375467 0
At 60 minutes and 2 hours after the child enters the post anaesthesia care unit
Secondary outcome [3] 375468 0
Post operative nausea; assessed by anti-emetic requirement and number of vomits
This will be retrospectively collected from study-specific outcome questionnaires, or hospital records
Timepoint [3] 375468 0
Post-operative period until discharge from post anaesthetic care unit
Secondary outcome [4] 375944 0
Time to discharge (from entering recovery until discharged home or to the surgical ward).
This will be retrospectively collected from study-specific outcome questionnaires, or hospital records
Timepoint [4] 375944 0
Post-operative period until discharge from post anaesthetic care unit

Eligibility
Key inclusion criteria
All children below 2 years of age, with no significant associated co-morbidities (American Society of Anaesthesiologists class 1 and 2), who are undergoing elective surgical procedures will be included.
This may include but is not limited to: inguinal hernia repair, orchidopexy, patent processus vaginalis ligation for hydrocoele, umbilical hernia repair and excision of skin lesions.
Minimum age
0 Years
Maximum age
2 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who have cardiac, respiratory or neurological conditions will be excluded, as well as those with a history of premature delivery.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The proposed sample size is 100 children. This size was based off feasibility in one years time, as no data is available in the literature to statistically determine it.
Approximately 20 children in this age group undergo elective surgery every month. Accounting for a recruitment rate of 60%, it is anticipated that it will take a maximum of 9 months to recruit the required sample size.

Results will be analysed after data extraction with dedicated statistical software (GraphPad Prism 8, MedCalc 19). Data will be expressed as mean ± standard deviation (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 ANOVA tests will be used where appropriate to identify differences between groups of children undergoing different surgical procedures. Correlation analysis will be conducted to investigate the relationship between the intraoperative NIPE index and post-operative outcomes. Subset analysis for the duration of anaesthesia with different types of surgical procedures will be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/03/2020
Actual
1/04/2021
Date of last participant enrolment
Anticipated
31/10/2021
Actual
31/10/2021
Date of last data collection
Anticipated
31/03/2022
Actual
31/10/2021
Sample size
Target
100
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14924 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 28193 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 303647 0
Hospital
Name [1] 303647 0
Monash Children's Hospital
Country [1] 303647 0
Australia
Primary sponsor type
Hospital
Name
Monash Children's Hospital
Address
246 Clayton Road, Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 303736 0
None
Name [1] 303736 0
Address [1] 303736 0
Country [1] 303736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304171 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 304171 0
Research Support Services
Monash Health
Level 2, I Block
Monash Medical Centre
246 Clayton Road
Clayton, VIC 3168
Ethics committee country [1] 304171 0
Australia
Date submitted for ethics approval [1] 304171 0
15/10/2019
Approval date [1] 304171 0
06/03/2020
Ethics approval number [1] 304171 0

Summary
Brief summary
This study will explore whether intraoperative NIPE values correlate to the level of post-operative pain and the amount of analgesia required after elective surgery in children. This has not yet been explored, and could ultimately result in less pain and distress to children and their carers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96038 0
Mr Maurizio Pacilli, MBBS (Hons), MD (Res), FRCS (Paed. Surg)
Address 96038 0
Department of Paediatric Surgery,
Level 5, Monash Children's Hospital
246 Clayton Road,
Clayton VIC 3168
Country 96038 0
Australia
Phone 96038 0
+61 385723837
Fax 96038 0
Email 96038 0
maurizio.pacilli@monash.edu
Contact person for public queries
Name 96039 0
Miss Lauren Tong, Medical Student at Monash University
Address 96039 0
Surgical Simulation Centre
Level 3, Monash Children's Hospital
246 Clayton Road,
Clayton VIC 3168
Country 96039 0
Australia
Phone 96039 0
+61 385723837
Fax 96039 0
Email 96039 0
lston1@student.monash.edu
Contact person for scientific queries
Name 96040 0
Mr Maurizio Pacilli, MBBS (Hons), MD (Res), FRCS (Paed. Surg)
Address 96040 0
Department of Paediatric Surgery,
Level 5, Monash Children's Hospital
246 Clayton Road,
Clayton VIC 3168
Country 96040 0
Australia
Phone 96040 0
+61 385723837
Fax 96040 0
Email 96040 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.