Clinical Trial: 7% Lidocaine/7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double Blind Randomized Controlled Trial Comparing the Efficacy of 7% Lidocaine / 7% Tetracaine Cream Versus 2,5% Lidocaine / 2,5% Prilocaine Cream for Local Anaesthesia During Laser Treatment of
Brief Summary: The purpose of this study is to compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal.
Detailed Summary:
In this study we will compare the efficacy of 7% lidocaine / 7% tetracaine cream and 2,5% lidocaine / 2,5% prilocaine cream in reducing self-reported pain during a single laser procedure in the treatment of acne keloidalis nuchae and tattoo removal. Patients will be asked to fill in questionnaires to:
- assess the severity of pain experienced (VAS score) during laser treatment,
- evaluate whether the pain relief is adequate and,
- evaluate the amount of money patients would be willing to pay for the cream that provided the 'best' pain relief.
One week after the visit the patient will have a telephone consultation. The patients will be asked if they experienced any symptoms, which will be recorded as adverse events.
Sponsor: Erasmus Medical Center
Current Primary Outcome: Self-reported pain (10 point visual analog scale). [ Time Frame: 5 minutes ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- adequate pain relief (yes/no); [ Time Frame: 10 minutes ]
- willing to spend around 25 euro for best pain relief (yes/no). [ Time Frame: 10 minutes ]
- To monitor the nature and frequency of adverse events [ Time Frame: one week ]
Original Secondary Outcome:
- adequate pain relief (yes/no); [ Time Frame: 10 minutes ]
- willing to spend around 25 euro for best pain relief (yes/no). [ Time Frame: Same day as treatment ]
- To monitor the nature and frequency of adverse events [ Time Frame: one week ]
Information By: Erasmus Medical Center
Dates:
Date Received: February 12, 2015
Date Started: November 2014
Date Completion:
Last Updated: January 19, 2016
Last Verified: January 2016