CompletedPhase 4ACTRN12613000996763

A double blind randomised controlled trial assessing the effect of 30% topical lidocaine gel on reducing pain in patients presenting to a cosmetic surgery practice with either prominent periorbital or lateral temporal veins for treatment with Neodymium-Doped Yttrium Aluminum Garnet (ND:TAG))

In patients presenting to a cosmetic surgery practice with either prominent periorbital or lateral temporal veins, what is the effect of 30% topical lidocaine gel on pain as assessed on a visual analogue scale compared to placebo?


Sponsor

University of Toronto

Enrollment

10 participants

Start Date

Jul 2, 2013

Study Type

Interventional

Conditions

Summary

Some individuals have cosmetically un-pleasing prominent blue veins under their eyes or in their temporal regions. Although there are a number of methods to treat these, a simple, effective and safe method is using a type of laser called ND:YAG which targets the blue pigment in the vein. Unfortunately, patients often describe this as uncomfortable or painful. Therefore, the purpose of this study is to determine if using a lidocaine gel prior to treatment will result in a reduction in pain.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

  • 18 years of age or older
  • Cosmetically significant lateral temporal or infra-orbital as subjectively judged by the patient

Exclusion Criteria2

  • known sensitivity or allergy to any topical or other anaesthetic medication
  • unilateral veins only

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Interventions

1cc volume of topical 30% lidocaine in Lipothene gel (Treatment). This was a split body design such that for each patient, one side of the face received the treatment gel and the other side of the

1cc volume of topical 30% lidocaine in Lipothene gel (Treatment). This was a split body design such that for each patient, one side of the face received the treatment gel and the other side of the face received the placebo gel. Both the treatment and the placebo gel was applied over prominent veins on the infra-orbit and/or lateral temporal area using a cotton tip applicator. Only veins identified by the surgeon and patient undergoing the treatment was treated with the intervention. The intervention and placebo gel remained on the patients face for 15 minutes.


Locations(1)

Ontario, Canada

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ACTRN12613000996763