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Trial registered on ANZCTR
Registration number
ACTRN12626000952347
Ethics application status
Approved
Date submitted
1/07/2026
Date registered
3/08/2026
Date last updated
3/08/2026
Date data sharing statement initially provided
3/08/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
A study in children aged 8-18 years to assess whether the J-Tip® device is feasible, safe and acceptable for reducing pain during intravenous cannulation compared with standard care.
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Scientific title
A two-arm feasibility randomised control trial (RCT) in children aged 8-18 years evaluating the feasibility, safety and acceptability of the J-Tip® device compared with standard care for peripheral intravenous cannulation (PIVC), with child-reported pain as the primary clinical endpoint for a future phase II trial.
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Additional trial identifiers [1]
317379
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
DOLPHIN
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Related trial records
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Health condition
Health condition(s) studied:
Pain associated with insertion of peripheral intravenous cannulation (PIVC) in children.
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Condition category
Condition code
Anaesthesiology
338127
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
The intervention is the intradermal administration of a single 0.25 mL dose of 1% lidocaine using the CO2-powered J-Tip® needle-free device to provide local anaesthesia prior to peripheral intravenous cannulation (PIVC). It is delivered face-to-face on an individual basis by a registered nurse with specialist PIVC insertion skills, immediately before cannulation in children aged 8-18 years. The intervention is provided once per cannulation episode within a tertiary paediatric hospital setting. For application, the J-Tip® device is positioned perpendicular to the skin at the selected cannulation site and activated to deliver 0.25 mL of 1% lidocaine via a high-pressure stream into the intradermal/subcutaneous tissue without the use of a needle. Following successful administration, PIVC insertion proceeds according to routine clinical practice. Fidelity to the intervention is monitored through protocolised staff training and procedural checklists documenting device preparation, site selection, dose administration, and adherence to the intervention protocol
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Intervention code [1]
334174
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Treatment: Devices
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Intervention code [2]
334470
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Prevention
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Description of the comparator or control
The comparator is standard care, consisting of topical anaesthesia (4% lidocaine cream or a combination of lidocaine 2.5% with prilocaine 2.5%) without additional injected local anaesthetic. It is delivered face-to-face on an individual basis by a registered nurse with experience in peripheral intravenous cannulation, who applies a layer of topical anaesthetic to intact skin at one or more potential cannulation sites, covers it with an occlusive dressing, and allows it to remain in situ for a minimum of 30 minutes (lidocaine 4%) or 60 minutes (lidocaine 2.5%-prilocaine 2.5%) prior to cannulation. The intervention is provided once per cannulation episode within a tertiary paediatric hospital setting, with adherence monitored through clinical documentation confirming correct application, timing, and site preparation.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility of a full efficacy trial
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Assessment method [1]
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Composite primary outcome: Feasibility of conducting a future full efficacy trial will be assessed using the following composite criteria: Eligibility: At least 75% of screened patients will meet all study inclusion criteria and no exclusion criteria, assessed using screening records entered in the REDCap database. Recruitment: At least 75% of eligible patients will provide informed consent and enrol in the study, assessed using screening and enrolment data recorded in the REDCap database. Retention and attrition: Fewer than 5% of enrolled participants who complete study procedures according to protocol will be lost to follow-up or withdraw from the study, assessed using participant enrolment and withdrawl data recorded in the REDCap database. Protocol fidelity: At least 80% of participants will receive their allocated intervention as intended and complete study outcome assessments according to protocol, assessed using study records within the REDCap database. Missing data: Less than 10% of data will be missing for study outcomes and feasibility measures, assessed through review of data completeness within the REDCap database. Acceptability: At least 80% of parents and healthcare staff will report satisfaction with the allocated intervention, assessed using a 5-point Likert scale questionnaire recorded in the REDCap database, with ratings of 4 or 5 classified as satisfied. Safety: Fewer than 5% of participants will experience an adverse event attributable to J-Tip® administration, assessed using adverse event data recorded in the REDCap database. Adverse events include local skin reactions (e.g. mild erythema), bleeding or bruising, and systemic effects such as dizziness, tinnitus or peri-oral numbness. Events will be monitored through clinician observation and participant or parent reporting from administration of intervention until 48 hours after PIVC removal or hospital discharge, whichever occurs first.
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Timepoint [1]
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On completion of 60 participants
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Primary outcome [2]
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Child-reported pain during peripheral intravenous cannulation (PIVC) insertion.
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Assessment method [2]
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Participants pain during PIVC insertion will be self-reported using the eleven point numerical rating scale (NRS-11) where 0= no pain and 10 =worst possible pain.
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Timepoint [2]
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Single timepoint within 30 minutes of cannulation
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Secondary outcome [1]
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Peripheral intravenous cannulation (PIVC) insertion success
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Assessment method [1]
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PIVC insertion success is defined as the ability to infuse 0.9% sodium chloride (3-10mL), adjusted for patient weight and/or clinical condition) without resistance or evidence of swelling at the insertion site.
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Timepoint [1]
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At time of insertion.
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Secondary outcome [2]
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Number of PIVC insertion attempts
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Assessment method [2]
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The number of PIVC insertion attempts will be recorded as the total number of skin punctures required for successful insertion, as documented by the inserter (or observed by Nurse or other personnel assisting insertion).
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Timepoint [2]
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At completion of procedure.
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Secondary outcome [3]
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Time to successful PIVC insertion.
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Assessment method [3]
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Time to successful PIVC insertion will be measured in minutes measured by stopwatch timer.
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Timepoint [3]
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At time of successful PIVC insertion.
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Secondary outcome [4]
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Child-reported pain during peripheral intravenous cannulation (PIVC) insertion.
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Assessment method [4]
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Measured using the Numerical Rating Scale (NRS-11), where 0=no pain and 10=worst possible pain.
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Timepoint [4]
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Assessed once immediately following PIVC insertion.
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Secondary outcome [5]
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Acceptability of the intervention.
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Assessment method [5]
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Children will rate their experience with the received intervention (topical anaesthetic or J-Tip® using a 5-point Likert scale (1=extremely dissatisfied to 5=extremely satisfied), with responses collected by a research nurse.
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Timepoint [5]
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Assessed immediately prior to PIVC insertion, following topical anaesthetic removal or J-Tip® application.
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Secondary outcome [6]
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PIVC dwell time.
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Assessment method [6]
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Measured as the duration (in hours) from successful PIVC insertion to catheter removal, using data collected from electronic medical records and recorded in the REDCap database.
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Timepoint [6]
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Assessed at the time of PIVC removal
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Secondary outcome [7]
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PIVC failure where the catheter is no longer suitable for treatment.
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Assessment method [7]
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PIVC failure will be determined by the supervising clinician based on clinical assessment and participant self-report and defined as cessation of catheter function rendering it unsuitable for treatment due to any of the following: inability to tolerate infusion due to pain (assessed using the NRS-11), infiltration or extravasation (movement of IV fluid into surrounding tissue with or without tissue damage), blockage or occlusion (with or without leakage), phlebitis (presence of pain or tenderness, redness swelling or a palpable cord/vein streak from the entry site), thrombosis (radiologically confirmed using ultrasound), dislodgement (partial or complete catheter displacement where the hub is no longer snug to the skin insertion point or the catheter completely leaves the vein), primary bloodstream infection (Laboratory confirmed bloodstream infection [BSI] as per the Centres for Disease Control, with no other source] or local infection (purulent drainage at the insertion site).
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Timepoint [7]
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Assessed at time of PIVC failure.
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Secondary outcome [8]
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Device-related complications.
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Assessment method [8]
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Device-related complications will be defined as any adverse events directly associated with the PIVC or J-Tip® application, including local skin reactions and procedural complications and will be identified through clinical documentation, with additional reporting from participant/parent where applicable.
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Timepoint [8]
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Assessed during the procedure, and for up to 48 hours post-insertion or until catheter removal, failure or discharge from hospital (whichever occurs first).
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Eligibility
Key inclusion criteria
Children aged 8-18 years who are able to self-report pain (using the NRS-11) and require peripheral venous cannulation (PIVC) with parent/guardian consent and child assent.
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Minimum age
8
Years
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Maximum age
18
Years
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
Children with previous participation in the study, inability to provide consent or assent, altered consciousness (with or without sedation), or known hypersensitivity or allergy to the intervention or standard care agents will be excluded.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using a secure-web based randomisation system, with the sequence generated by an independent statistician and assignment revealed only at the time of randomisation by the research nurse.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer-generated using permuted blocks of variable size and stratified by age group and first-time versus repeat PIVC insertion, by an independent statistician not involved in recruitment or clinical care.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
A sample size of 60 participants (30 per group) was selected based on recommendations for feasibility studies, providing sufficient precision to estimate recruitment and retention rates and to obtain preliminary estimates of variability in pain scores. These data will inform sample size calculations for a future definitive trial.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/08/2026
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Actual
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Date of last participant enrolment
Anticipated
2/02/2027
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Actual
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Date of last data collection
Anticipated
9/02/2027
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
46002
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4101 - South Brisbane
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Australian Pain Society Clinical Grants and Scholarships and Cops for Kids
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Queensland Children's Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
325466
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Country [1]
325466
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
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http://www.childrens.health.qld.gov.au/research/human-research-ethics-committee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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02/03/2026
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Approval date [1]
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31/03/2026
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Ethics approval number [1]
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HREC/2026/QCHQ/125292
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Summary
Brief summary
This study will compare a needle-free device (J-Tip®) with standard care (topical numbing cream) in children aged 8-18 years requiring IV cannulation. The aim is to determine whether a larger trial is feasible by assessing recruitment, study processes, safety, and acceptability. Children's pain during cannulation will also be measured to inform a future trial testing whether the J-Tip® reduces pain.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Catherine Kotzur
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Address
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Queensland Children's Hospital, 501 Stanley Street, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 429682477
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Catherine Kotzur
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Address
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Queensland Children's Hospital, 501 Stanley Street, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 429682477
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Tricia Kleidon
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Address
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Queensland Children's Hospital, 501 Stanley Street, South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 407175301
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Individual participant data will not be shared to protect participant confidentiality and comply with ethical and legislative requirements. No identifiable information will be included in any publications or shared datasets.
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.
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