Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000810415p
Ethics application status
Submitted, not yet approved
Date submitted
27/06/2025
Date registered
29/07/2025
Date last updated
29/07/2025
Date data sharing statement initially provided
29/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain after joint steroid injections in children with Juvenile arthritis
Scientific title
Pilot study Assessing Post-Procedural Pain in Children with Juvenile Idiopathic Arthritis Following Intra-Articular Steroid Injections: A Questionnaire-Based Study
Secondary ID [1] 314418 0
DERP ID 4392
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic arthritis 337499 0
Condition category
Condition code
Inflammatory and Immune System 333863 333863 0 0
Other inflammatory or immune system disorders
Musculoskeletal 334579 334579 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Brief Name:
“Pilot study Assessing Post-Procedural Pain in Children with Juvenile Idiopathic Arthritis Following Intra-Articular Steroid Injections: A Questionnaire-Based Study”

Description of Intervention/Exposure:
This is a single-site, prospective study investigating post-procedural pain and recovery in children with juvenile idiopathic arthritis (JIA) undergoing intra-articular steroid injection (IASI) with the routine use of intra-articular lignocaine administered at the time of injection.

Procedure details:
All participants will receive a single intra-articular steroid injection under sedation, as part of standard clinical care. Immediately after the steroid is administered, a dose of intra-articular lignocaine will be injected into the joint to provide local analgesia as part of their standard treatment.. The specific joint injected (e.g. knee, ankle, wrist, elbow) and any procedural variables (e.g. difficulty of injection, number of attempts) will be recorded.

Duration of observation:
Children will be followed for 30 hours post-procedure, with assessments conducted at 1, 2, 4, and 24–30 hours after IASI via structured caregiver interviews.

Data collection methods:
Data will be collected on pain scores (using age-appropriate scales), anxiety levels (child and caregiver), use of analgesics or mobility aids, and return to physical activities and school. Data will be obtained via telephone contact with the primary caregiver.

Personnel involved:
IASI procedures and lignocaine administration will be performed by trained paediatric rheumatologists. Consent and Follow-up assessments will be conducted by the independent research team.

Location:
Procedures will occur at the Royal Children’s Hospital (RCH), Melbourne, and follow-up will be completed remotely.

Assessment of fidelity:
This study embedded in routine care, no intervention fidelity measures apply. Procedural details will be captured in medical records and confirmed during data collection.
Intervention code [1] 331087 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341494 0
Pain following intra-articular ateroid injections
Timepoint [1] 341494 0
Baseline, 10 min, 1, 2, 4 and 24-30h postprocedure
Secondary outcome [1] 447762 0
Baseline patient procedural anxiety
Timepoint [1] 447762 0
Nil, Patient procedural anxiety will be measured only at baseline
Secondary outcome [2] 447765 0
Baseline Care giver procedural anxiety
Timepoint [2] 447765 0
Nil secondary timepoint, caregiver anxiety will be assessed only at baseline.
Secondary outcome [3] 447767 0
Need for post-procedural analgesia
Timepoint [3] 447767 0
24-30hr
Secondary outcome [4] 450143 0
Time taken for the child to return to regular physical activities post-procedure
Timepoint [4] 450143 0
24-30 hr post procedure
Secondary outcome [5] 450144 0
Need for mobility aids post-procedure
Timepoint [5] 450144 0
24-30hr post procedure

Eligibility
Key inclusion criteria
Each participant must meet all the following criteria to be enrolled in this study:
- Aged between 6 and 18 years at the time of enrolment.
- Has a confirmed diagnosis of Juvenile Idiopathic Arthritis (JIA), based on the International League of Associations for Rheumatology (ILAR) classification criteria.
- Scheduled to undergo elective intra-articular steroid injection of a single joint under procedural sedation at the Royal Children’s Hospital.
- Single joint injections will include the Knee, elbow, wrist and ankle joints only.
- Is medically stable and able to participate in post-procedural follow-up over a 24-hour period.
- Has a parent or legally authorized representative capable of understanding the study information and providing written informed consent.
- Where age-appropriate, the participant can provide verbal or written assent.
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants meeting any of the following criteria at baseline will be excluded from this study:
- Has a developmental delay or cognitive impairment that would preclude reliable self-reporting or caregiver-assisted completion of pain assessments (as determined by the treating clinician).
- Will receive general anesthesia for the intra-articular steroid injection, rather than the standard procedural sedation protocol involving nitrous oxide and topical anesthetic.
- Has planned IASI of more than a single joint.
- Has a known hypersensitivity or contraindication to any medication used in the procedure, including nitrous oxide, topical anesthetics (e.g., EMLA or equivalent), or intra-articular lignocaine.
- Is experiencing an acute febrile illness or active infection at the time of the scheduled procedure that may compromise safety or interfere with pain reporting.
- Has a clinically diagnosed psychiatric condition (e.g., severe anxiety disorder, psychosis, or behavioral disorder) in either the child or the primary caregiver that would interfere with participation, communication, or follow-up.
- Has a co-morbid condition with a life expectancy of less than 6 months or any condition that would preclude meaningful follow-up within 24 hours post-procedure.
- Has a history of receiving another clinical intervention within the last 30 days that may interfere with pain perception, anxiety scores, or general recovery patterns (e.g., surgery, clinical drug trials).
- Is unable or unwilling to return pain or follow-up data during the 24-hour post-procedural period (e.g., due to planned travel or lack of contact access).
- Refusal or inability of the participant and/or their legally authorized representative to provide written informed consent (and assent where appropriate).
- Has limited English proficiency without access to a translator or translated questionnaires, where this would compromise the validity or reliability of data collected.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This is a prospective study with a single cohort of children with juvenile idiopathic arthritis (JIA) undergoing a single intra-articular steroid injection (IASI). As there is no control group and the study is not designed to test a specific hypothesis or treatment effect, a formal sample size calculation based on statistical power is not applicable.
Instead, the sample size is based on feasibility and clinical throughput at the Royal Children’s Hospital. Based on retrospective review of clinic volumes and expected procedure frequency, we anticipate enrolling approximately 15–25 participants over the study period.
This sample size will allow us to:
• Estimate average post-procedural pain and describe the variability in pain scores across key time points.
• Assess the distribution of anxiety levels pre- and post-procedure.
• Describe time to return to school and physical activity, and the proportion of children requiring additional analgesia or mobility aids.
• Explore potential trends and associations between patient characteristics and outcomes to inform future, larger studies.
This study is not powered to detect statistically significant differences but is intended to provide foundational data for hypothesis generation and the design of future controlled studies.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27958 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 44150 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 318946 0
Hospital
Name [1] 318946 0
Royal Children's Hospital (RCH)
Country [1] 318946 0
Australia
Primary sponsor type
Hospital
Name
Royal children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 321414 0
Other
Name [1] 321414 0
Murdoch Children’s Research Institute (MCRI)
Address [1] 321414 0
Country [1] 321414 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317553 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 317553 0
Ethics committee country [1] 317553 0
Australia
Date submitted for ethics approval [1] 317553 0
27/06/2025
Approval date [1] 317553 0
Ethics approval number [1] 317553 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141418 0
Dr Yehonatan Herman
Address 141418 0
Royal Children’s Hospital, 50 Flemington Rd, Parkville, VIC 3052
Country 141418 0
Australia
Phone 141418 0
+61431970777
Fax 141418 0
Email 141418 0
[email protected]
Contact person for public queries
Name 141419 0
Yehonatan Herman
Address 141419 0
Royal Children’s Hospital, 50 Flemington Rd, Parkville, VIC 3052
Country 141419 0
Australia
Phone 141419 0
+61431970777
Fax 141419 0
Email 141419 0
[email protected]
Contact person for scientific queries
Name 141420 0
Yehonatan Herman
Address 141420 0
Royal Children’s Hospital, 50 Flemington Rd, Parkville, VIC 3052
Country 141420 0
Australia
Phone 141420 0
+61431970777
Fax 141420 0
Email 141420 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    STUDY PROTOCOL FINAL 29.7.25.docx


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.