Pharynx Analgesia Before Upper Gastrointestinal Endoscopy (PHRASE)

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 versus xilocaine spray topical anesthesia of the pharynx, before procedure.

Study Overview

• Status: Recruiting
• Conditions: Upper Gastrointestinal Endoscopy
• Intervention / Treatment: Drug: Strepsils Intensiv Arm; Drug: Xilocaine Spray Arm

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 [1,2] 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 [1].

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 [3]. 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 improves the satisfaction score of the patient as compared to standard xilocaine spray.

Hypothesis A topical NSAID will improve the satisfaction score of the patient during upper GI endoscopy.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mihai Ciocirlan; Phone Number: 0040722322625; Email: ciocirlanm@yahoo.com

Study Locations

• Romania
  • Bucharest, Romania
    • Recruiting
    • "Agrippa Ionescu" Hospital
    • Contact: Mihai L Ciocirlan; Phone Number: 0040722322625; Email: mihai.ciocirlan@umfcd.ro

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strepsils Intensiv Arm; Patient will take one pill of Strepsils Intensiv containing 8.75mg flurbiprofen 10 to 15 minutes before endoscopy. The patient will not have pharyngeal topical xilocaine spray before upper GI endoscopy.	Drug: Strepsils Intensiv Arm; After Stepsils Intensiv ingestion, upper GI endoscopy will be performed with a standard diameter tube, with SpO2 non invasive monitoring.; Other Names: Strepsils
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Carol Davila University of Medicine and Pharmacy

Publications and helpful links

General Publications

• Amornyotin S, Srikureja W, Chalayonnavin W, Kongphlay S, Chatchawankitkul S. Topical viscous lidocaine solution versus lidocaine spray for pharyngeal anesthesia in unsedated esophagogastroduodenoscopy. Endoscopy. 2009 Jul;41(7):581-6. doi: 10.1055/s-0029-1214865. Epub 2009 Jul 8.
• Chan CK, Fok KL, Poon CM. Flavored anesthetic lozenge versus Xylocaine spray used as topical pharyngeal anesthesia for unsedated esophagogastroduodenoscopy: a randomized placebo-controlled trial. Surg Endosc. 2010 Apr;24(4):897-901. doi: 10.1007/s00464-009-0687-9.
• Mahawongkajit P, Talalak N, Soonthornkes N. Comparison of Lidocaine Spray and Lidocaine Ice Popsicle in Patients Undergoing Unsedated Esophagogastroduodenoscopy: A Single Center Prospective Randomized Controlled Trial. Clin Exp Gastroenterol. 2021 May 25;14:209-216. doi: 10.2147/CEG.S301163. eCollection 2021.

Helpful Links

• Paper

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 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 (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• 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