Pharynx Analgesia Before Upper Gastrointestinal Endoscopy (PHRASE)

November 9, 2024 updated by: Mihai Ciocirlan, Carol Davila University of Medicine and Pharmacy

Pharynx Analgesia Before Upper Gastrointestinal Endoscopy: a Prospective, Randomized Comparative Trial

This is a comparative study on patient and endoscopist experience during upper gastrointestinal endoscopy with NSAIDs (flurbiprofen) topical analgesia plus xilocaine spray topical anesthesia of the pharynx versus xilocaine spray topical anesthesia of the pharynx alone, before procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Upper gastrointestinal endoscopy may be done with topical anesthesia of the pharynx with xilocaine spray, with conscious sedation with midazolam or with general anesthesia with propofol. In Romania, the endoscopist may only offer topical pharyngeal anesthesia, any other sedation or anesthesia needs the presence of an anesthesiologist on premises.

Xilocaine spray improves the gag reflux and the satisfaction score of the patient as well as the ease of insertion and the satisfaction score of the endoscopist.

A study published in 2010 has compared the tolerance of upper GI endoscopy in patients in which the topical anesthesia of the pharynx has been done using Strepsils Plus with xilocaine versus xilocaine spray. The group of patients with Strepsils Plus had a significantly lower tolerance, lower anesthesia score, a higher gag score and a higher disconfort score versus patients in group with xilocaine spray.

Nevertheless, topical pharyngeal anesthesia with benzocaine spray and in much lesser degree with xilocaine spray may lead to a very rare adverse reaction, namely methemoglobinemia. That is why, an safer alternative to xilocaine spray would be desirable at this moment.

Question at which the research protocol is trying to answer The investigators intent to evaluate whether a topical pharyngeal anti inflammatory molecule, a non steroidal anti inflammatory drug (NSAID), that is Strepsils Intensive with honey and lemon which contains flurbiprofen 8.75mg before upper GI endoscopy plus xilocaine spray improves the satisfaction score of the patient as compared to standard xilocaine spray alone.

Hypothesis A topical NSAID will improve the satisfaction score of the patient during upper GI endoscopy, when added to xilocaine spray.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania
        • "Agrippa Ionescu" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with indication of upper gastrointestinal endoscopy with topical pharyngeal anesthesia with xilocaine spray
  • Age above 18 years
  • Informed consent

Exclusion Criteria:

  • Allergy to xilocaine and/or flurbiprofen
  • Absence of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Xilocaine Spray Arm
The patient will have pharyngeal topical xilocaine spray before upper GI endoscopy, 5 puffs in two applications immediately before examination.
Drug: Xilocaine Spray Arm
After Xilocaine Spray pharyngeal topical anestesia, upper GI endoscopy will be performed with a standard diameter tube, with SpO2 non invasive monitoring.
Other Names:
  • Xilocaine
Experimental: Strepsils Intensiv Arm + Xilocaine Spray

Patient will take one pill of Strepsils Intensiv containing 8.75mg flurbiprofen 10 to 15 minutes before endoscopy.

The patient will have pharyngeal topical xilocaine spray before upper GI endoscopy, 5 puffs in two applications immediately before examination.
Drug: Strepsils Intensiv plus Xilocaine spray Arm
After Stepsils Intensiv ingestion, upper GI endoscopy will be performed with a standard diameter tube, with SpO2 non invasive monitoring.
Other Names:
  • Strepsils + Xilocaine Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction score
Time Frame: 24 hours
Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient discomfort score
Time Frame: 24 hours
Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)
24 hours
Patient pain score
Time Frame: 24 hours
Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)
24 hours
Patient gag score
Time Frame: 24 hours
Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum), by the endoscopist
24 hours
Endoscopist satisfaction score
Time Frame: 24 hours
Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carol Davila University of Medicine and Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 21, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 9, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRASE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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