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Trial registered on ANZCTR


Registration number
ACTRN12623000494639
Ethics application status
Approved
Date submitted
10/04/2023
Date registered
12/05/2023
Date last updated
27/08/2024
Date data sharing statement initially provided
12/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of topical anaesthetic for paediatric pulsed dye laser procedures without a general anaesthetic: a feasibility pilot randomised controlled trial.
Scientific title
Study of adjunct Topical Anaesthetic for Paediatric pulsed dye LasEr procedures (STAPLE): a feasibility pilot trial
Secondary ID [1] 309417 0
None
Universal Trial Number (UTN)
Trial acronym
STAPLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulsed dye laser procedures 329669 0
Periprocedural and intraprocedural pain 329670 0
Scars 329671 0
Vascular anomalies 329672 0
Condition category
Condition code
Surgery 326574 326574 0 0
Other surgery
Anaesthesiology 326855 326855 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325849 0
Treatment: Drugs
Comparator / control treatment
The treatment will be tested against a placebo group.
The placebo participant group will undergo the same treatment as the active treatment group. However, instead of receiving Numit 5% cream will receive a non-active cream to the area to be treated with pulsed dye laser.
Control group
Placebo

Outcomes
Primary outcome [1] 334422 0
Feasibility will be a composite outcome, assessed by five parameters, detailed below.

1) Percentage of potential participants who are recruited for the study (out of all potentially eligible children), as assessed by an audit of study recruitment records.

2) Percentage of participants who are successfully randomised to a treatment group, as assessed by study recruitment and randomisation records. Reasons why a participant may not be randomised include, but are not limited to, the participant's pulsed dye laser procedure being delayed due to other health issues, the participant's pulsed dye laser procedure being delayed due to hospital issues (e.g. pandemic-associated elective theatre closures).

3) Percentage of randomised participants who receive their allocated treatments.
This will be assessed by fidelity checklists for the intervention (topical anaesthetic cream or topical placebo). For example, a randomised child may repeatedly remove their cream pre-procedurally, which would mean the intervention has not been delivered in the correct manner. This will be assessed by review of the intervention fidelity checklists.

4) Percentage of complete data for primary and secondary outcomes.
This will be assessed by auditing the data obtained and determining if there are missing data points.

5) Percentage of participants who are lost to follow-up or withdraw from the study, as assessed by audits of study records.
Timepoint [1] 334422 0
At trial completion
Secondary outcome [1] 420577 0
Acceptability of the trial to the participant, their family and staff will be assessed via Theoretical Framework of Acceptability (TFA) questionnaires, modified appropriately for each group. The groups assessed will be:
1) Participants > 8 years old
2) Participant caregivers
3) Theatre staff
4) Pharmacy staff
Timepoint [1] 420577 0
Participants > 8years old and participant caregivers will receive a TFA after their procedure prior to leaving hospital.

Theatre staff will receive a TFA at the end of every operating theatre list. Pharmacy staff will receive a TFA at the start of the study, after 25 patients have received the intervention, and at the end of the study.
Secondary outcome [2] 420578 0
Pre-procedural anxiety will be recorded for all participants to ensure that the two groups are balanced. This will be measured using a visual analogue scale for anxiety, which is validated for the assessment of anxiety in the peri-operative setting for children aged 7 years and above. For children aged 1.5 to 7 years old, the caregiver will be asked to complete the VAS, and children more than 7 years old will be asked to complete it themselves.
Timepoint [2] 420578 0
1) Participants - pain will be assessed prior to the laser procedure, intraprocedurally (retrospective assessment done by the participant immediately after their laser), and immediately after the procedure 2) Participant caregivers - will be asked to assess their child's pain prior to the laser procedure, during the procedure (retrospective assessment done by the caregivers immediately after the laser procedure) and immediately after the laser. They will be contacted the day after the procedure to ask about whether there was pain overnight or whether any analgesia was given at home. 3) Observer - will rate the participant's pain pre-operatively, during the procedure, and immediately after the procedure.
Secondary outcome [3] 420579 0
Laser treatment efficacy will be assessed to determine if there is a difference between the groups. This will be assessed differently, depending on what the laser procedure is being conducted for. 1) Scars - if the laser treatment is for a scar, the scar will be assessed using the Brisbane Burn Scar Impact Profile scale. 2) Vascular malformations - vascular malformations will be assessed by caregivers on a visual analogue scale about how satisfied they are with the treatment. Participants more than eight years old will also be asked to complete this scale. - the response of the vascular malformation will also be assessed by their treating doctor using an overall percentage improvement score.
Timepoint [3] 420579 0
1) Scars will be assessed pre-operatively and two months post-operatively
2) Vascular malformations will be assessed approximately two weeks post-operatively.

Eligibility
Key inclusion criteria
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.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocations will be concealed from participants, their caregivers, theatre staff and study investigators. Central randomisation will be performed via an electronic randomisation service, with unblinded allocations being sent to the pharmacy department. The pharmacy department will then dispense the placebo or active treatment (depending on participant allocation) in a participant-labelled glass jar.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Variable block randomisation, performed by a central randomisation service (computer software-generated sequence)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomisation stratified by the laser received (pulsed dye laser or NdYAG laser)
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/10/2023
Actual
11/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 313587 0
Other
Name [1] 313587 0
The Walker Fellowship
Country [1] 313587 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
501 Stanley St, South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 315404 0
University
Name [1] 315404 0
Griffith University
Address [1] 315404 0
170 Kessels Road, Nathan, QLD, 4101
Country [1] 315404 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312765 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 312765 0
Ethics committee country [1] 312765 0
Australia
Date submitted for ethics approval [1] 312765 0
Approval date [1] 312765 0
28/03/2023
Ethics approval number [1] 312765 0
HREC/23/QCHQ/91002
Ethics committee name [2] 315998 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 315998 0
Ethics committee country [2] 315998 0
Australia
Date submitted for ethics approval [2] 315998 0
08/05/2023
Approval date [2] 315998 0
08/05/2023
Ethics approval number [2] 315998 0
2023/308

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125830 0
Dr Maria Shilova
Address 125830 0
Queensland Children's Hospital
Paediatric Surgery Department
501 Stanley St
South Brisbane
Queensland
4101
Country 125830 0
Australia
Phone 125830 0
+61 457 915 080
Fax 125830 0
Email 125830 0
[email protected]
Contact person for public queries
Name 125831 0
Maria Shilova
Address 125831 0
Queensland Children's Hospital
Paediatric Surgery Department
501 Stanley St
South Brisbane
Queensland
4101
Country 125831 0
Australia
Phone 125831 0
+61 457915080
Fax 125831 0
Email 125831 0
[email protected]
Contact person for scientific queries
Name 125832 0
Maria Shilova
Address 125832 0
Queensland Children's Hospital
Paediatric Surgery Department
501 Stanley St
South Brisbane
Queensland
4101
Country 125832 0
Australia
Phone 125832 0
+61 411427518
Fax 125832 0
Email 125832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18831Study protocol  [email protected] The protocol will be formally published.



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.