Pharynx Analgesia Before Upper Gastrointestinal Endoscopy

Upper Gastrointestinal Endoscopy Clinical Trial

— PHRASE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06220175
• Other study ID #: PHRASE
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: Mihai Ciocirlan
• Phone: 0040722322625
• Email: ciocirlanm[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Upper Gastrointestinal Endoscopy

Intervention

Drug:
• Strepsils Intensiv Arm
After Stepsils Intensiv ingestion, upper GI endoscopy will be performed with a standard diameter tube, with SpO2 non invasive monitoring.
• 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.

Locations

Country	Name	City	State
Romania	"Agrippa Ionescu" Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Carol Davila University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction score	Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)	24 hours
Secondary	Patient discomfort score	Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)	24 hours
Secondary	Patient pain score	Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)	24 hours
Secondary	Patient gag score	Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum), by the endoscopist	24 hours
Secondary	Endoscopist satisfaction score	Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)	24 hours

External Links

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