Clinical Trial: Efficacy Study of Articaine Lozenge to Enhance the Procedural Compliance of the Adults Undergoing Gastroduodenoscopy
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparison of Novel Articaine Lozenge Versus Placebo for Upper Gastrointestinal Endoscopy in Adults. A Randomized Double-blinded Controlled Study
Brief Summary: The purpose of this study is to examine in prospective, double-blinded randomised manner the ability of novel articaine-containing lozenge to enhance the procedure related compliance (compared to placebo) of the adult patients undergoing upper gastrointestinal endoscopy.
Detailed Summary:
Sponsor: Helsinki University Central Hospital
Current Primary Outcome: Percentage of participants with 15% change in tolerability points according to Numeric Rating Scale (compared to baseline Numeric Rating Scale). [ Time Frame: 30 minutes after the procedure ]
Original Primary Outcome: Percentage of participants with 15% change in tolerability points according to Visual Analogue Scale (compared to baseline Visual Analogue Scale). [ Time Frame: 30 minutes after the procedure ]
Current Secondary Outcome:
- Endoscopists´ procedural satisfaction points after the procedure assessed by using Numeric Rating Scale (NRS) [ Time Frame: within 30 minutes after the procedure ]
- Cumulative consumption of alfentanil during the procedure (mg) [ Time Frame: 30 minutes after the procedure ]
Original Secondary Outcome:
- Endoscopists´ procedural satisfaction points after the procedure assessed by using Visual Analogue Scale (VAS) [ Time Frame: within 30 minutes after the procedure ]
- Cumulative consumption of alfentanil during the procedure (mg) [ Time Frame: 30 minutes after the procedure ]
Information By: Helsinki University Central Hospital
Dates:
Date Received: March 29, 2014
Date Started: October 2014
Date Completion: December 2015
Last Updated: October 8, 2014
Last Verified: October 2014
