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Clinical Trial With Bupivacaine Lozenges as Local Anaesthesia Under Upper Gastrointestinal Endoscopy

NCT01832675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-04-16

No results posted yet for this study

Summary

In this project the investigators want to compare a new anaesthetic method during upper gastroscopic endoscopy, compared to the traditional used method in a private clinic. The new method is a lozenge containing bupivacaine, and the traditional method is a lidocaine spray.

Conditions

  • Application Site Discomfort

Interventions

DRUG

Xylocain, cutaneous spray, solution

10 mg lidocaine/spray. The patient will be sprayed three times and get a maximal dose of 30 mg lidocaine just before the examination.

DRUG

Bupivacaine lozenge

25 mg bupivacaine/lozenge. The patient will get one lozenge 10-15 minutes before the examination.

Sponsors & Collaborators

  • Oracain II Aps

    collaborator UNKNOWN

  • Ove Andersen

    lead OTHER

Principal Investigators

  • Kaare Nielsen, MD · Kirurgisk Klinik Hvidovre

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-08-31
Completion
2013-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01832675 on ClinicalTrials.gov