None listed
Conditions
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.
Interventions
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. F
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
Sponsors
Queensland Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed