NCT06220175

Pharynx Analgesia Before Upper Gastrointestinal Endoscopy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Carol Davila University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Upper Gastrointestinal Endoscopy

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2024-01-23
• Last updated: 2024-11-12

Locations

1 site across 1 country: Romania