RecruitingPhase 2ACTRN12623000494639

The use of topical anaesthetic for paediatric pulsed dye laser procedures without a general anaesthetic: a feasibility pilot randomised controlled trial.

Study of adjunct Topical Anaesthetic for Paediatric pulsed dye LasEr procedures (STAPLE): a feasibility pilot trial

Sponsor

Queensland Children's Hospital

Enrollment

50 participants

Start Date

Oct 11, 2023

Study Type

Interventional

Conditions

Scars Periprocedural and intraprocedural pain Pulsed dye laser procedures

Summary

Children can sometimes have pulsed dye laser procedures for birthmarks and scars without a general anesthetic. Instead of having a general anaesthetic, they instead have pain relief (paracetamol/ibuprofen) before their procedure and have access to additional pain relief during the procedure if required. It is unclear if, in this situation, children might benefit from having a numbing cream (topical anaesthetic) applied to their birthmark or scar before the laser. Any medications have their own risks associated with them, so we want to make sure that if we do start routinely using numbing cream in these situations, that it brings enough of a benefit for children that it would outweigh any associated risks with using numbing cream. We would like to do a study that looks at children's pain scores during and after laser procedures, and whether there is a difference in pain scores of children who have had numbing cream compared to children who receive a placebo (non-active) cream. The first step of doing such a study would be to check that it is feasible to do, and acceptable to everyone who might participate. That is what this feasibility pilot study will aim to do.

Eligibility

Sex: Both males and femalesMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Birthmarks, haemangiomas, and scars in children are sometimes treated with pulsed dye laser therapy — a procedure that uses focused light to target abnormal blood vessels or scar tissue. When this is done without a general anaesthetic, children experience some discomfort. A numbing cream (topical anaesthetic) applied beforehand might reduce this pain, but its benefits haven't been formally tested in this setting. This feasibility pilot trial at Queensland Children's Hospital will look at whether using a numbing cream called Numit is practical and acceptable for children having awake laser procedures. It will also look at whether children who receive it report less pain than children who receive a placebo cream. The information gathered will be used to design a larger, definitive trial. Your child may be eligible if they are under 18 and are scheduled for a pulsed dye or Nd:YAG laser procedure without general anaesthesia for a scar or vascular birthmark. Children with allergies to local anaesthetics, those under 12 months taking certain medications, and children with specific skin or health conditions are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Children who will be undergoing laser procedures without a general anaesthetic (pulsed dye laser or Nd:YAG laser) at the Queensland Children's Hospital will be recruited for this study. Participants

Children who will be undergoing laser procedures without a general anaesthetic (pulsed dye laser or Nd:YAG laser) at the Queensland Children's Hospital will be recruited for this study. Participants will be randomly allocated to either the active treatment or placebo group. Those in the active treatment group will receive topical Numit 5% (Lidocaine/Lignocaine 2.5% and Prilocaine 2.5%) cream over the area that is to be treated with pulsed dye laser. This will be approximately 30-60 minutes prior to their procedure, when the children arrive at the Queensland Children's Hospital for their laser procedure, and will be done by pre-operative nursing staff. The cream will be wiped off immediately prior to the procedure. Intervention fidelity will be monitored by the study investigators while the topical anaesthetic or placebo is applied using a fidelity checklist.