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

Inclusion Criteria3

Children <18 years of age
Undergoing laser procedures (pulsed dye or Nd:YAG laser) without a general anaesthetic
Pulse dye laser procedure may be conducted for either scars or vascular anomalies.

Exclusion Criteria14

Children who receive any other topical analgesic agents on the area to be lasered, as this can interfere with their pain sensation at the site and hence pain scores
Children who take oral analgesic medications regularly, as their intraoperative pain sensation may be influenced by their regular medication regimen and not be reflective of the standard patient group experience
Children with known allergies to prilocaine, lidocaine, or any local anaesthetics of the amide type, as these are contraindications for the treatment agent, and would render participation in the trial unsafe for the child
Children with known allergies to Numit cream excipients (ethoxylated hydrogenated castor oil, carbomer 934P, sodium hydroxide), as this is a contraindication for the treatment agent, and would render the child’s participation in the trial unsafe
Children with a personal or family history of glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methaemoglobinaenaemia, and children with atopic dermatitis or molluscum contagiousum, as these are either contraindications for the treatment agent or have been associated with local reactions to the treatment agent
Children who have a skin break in the site to be lasered, as there are no absorption data for the treatment agent in these conditions
Children with known allergies to paraffin or phenoxyethanol, which are ingredients of the placebo agent
Children under 12 months of age receiving methaemoglobin-inducing medications (e.g sulphonamides), as there is no safety data for the treatment agent in this group
Children taking anti-arrhythmic medications or cimetidine, as these could affect the clearance of the treatment agent and predispose to cardiac toxicity
Children who could potentially have altered pain scores due to absent sensation at the site to be lasered, such as spinal injury patients
Children with intellectual or communication disabilities, who may express pain differently, as the pain scoring tools used in this study may not be validated in this population
Children under the care of the Department of Communities, Child Safety and Disability Services (Child Safety), as they are a vulnerable population from an ethical perspective
Children whose legal guardians are unable to provide informed consent, such as those with diminished understanding or comprehension
Children whose treatment areas will exceed the maximal area that can be covered with Numit 5% cream based on their age group, as these children will not be able to receive adequate numbing cream on their whole lesion.

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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.