Pharynx Analgesia Before Upper Gastrointestinal Endoscopy

Not Applicable

Completed

• Conditions: Upper Gastrointestinal Endoscopy
• Interventions: Drug: Xilocaine Spray Arm; Drug: Strepsils Intensiv plus Xilocaine spray Arm

• Registration Number: NCT06220175
• Lead Sponsor: Carol Davila University of Medicine and Pharmacy

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-21
• Study First Posted: 2024-01-23
• Study Start: 2024-03-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-09
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xilocaine Spray Arm	Xilocaine Spray Arm	The patient will have pharyngeal topical xilocaine spray before upper GI endoscopy, 5 puffs in two applications immediately before examination.
Strepsils Intensiv Arm + Xilocaine Spray	Strepsils Intensiv plus Xilocaine spray Arm	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.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction score	24 hours	Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)

Secondary Outcome Measures

Name	Time	Method
Patient pain score	24 hours	Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)
Endoscopist satisfaction score	24 hours	Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)
Patient gag score	24 hours	Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum), by the endoscopist
Patient discomfort score	24 hours	Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)

Trial Locations

Locations (1)

"Agrippa Ionescu" Hospital; 🇷🇴 Bucharest, Romania