The use of topical anaesthetic for paediatric pulsed dye laser procedures without a general anaesthetic: a feasibility pilot randomised controlled trial.
- Conditions
- Pulsed dye laser proceduresPeriprocedural and intraprocedural painScarsVascular anomaliesSurgery - Other surgeryAnaesthesiology - Anaesthetics
- Registration Number
- ACTRN12623000494639
- Lead Sponsor
- Queensland Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
1.Children <18 years of age
2.Undergoing laser procedures (pulsed dye or Nd:YAG laser) without a general anaesthetic
3.Pulse dye laser procedure may be conducted for either scars or vascular anomalies.
1.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
2.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
3.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
4.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
5.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
6.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
7.Children with known allergies to paraffin or phenoxyethanol, which are ingredients of the placebo agent
8.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
9.Children taking anti-arrhythmic medications or cimetidine, as these could affect the clearance of the treatment agent and predispose to cardiac toxicity
10.Children who could potentially have altered pain scores due to absent sensation at the site to be lasered, such as spinal injury patients
11.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
12.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
13.Children whose legal guardians are unable to provide informed consent, such as those with diminished understanding or comprehension
14. 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method