Pharynx Analgesia Before Upper Gastrointestinal Endoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies

NCT02038894

Eosinophilic Esophagitis

COMPLETED NA

Oro-tracheal Intubation: Flurbiprofen Subglottic Instillation to Prevent Laryngeal Inflammation

NCT04708964

D010612

UNKNOWN PHASE2

Study on General Population of the Effect on Airway Protection of Drugs Used During Induction of General Anesthesia

NCT04413422

Aspiration

COMPLETED

Propofol and Sevoflurane for Catheter-Related Bladder Discomfort

NCT02252445

Catheter Site Discomfort Complications Anesthesia +1 more

COMPLETED NA

Does Strepsils® With Lignocaine Lozenges Reduce Post Operative Sore Throat Due To Supraglottic Airway Devices

NCT03944655

Sore Throat Post Operative Sore Throat

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Gastrointestinal Endoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Strepsils Intensiv plus Xilocaine spray Arm

Intervention Type DRUG

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

Xilocaine Spray Arm

The patient will have pharyngeal topical xilocaine spray before upper GI endoscopy, 5 puffs in two applications immediately before examination.

Group Type ACTIVE_COMPARATOR

Xilocaine Spray Arm

Intervention Type DRUG

After Xilocaine Spray pharyngeal topical anestesia, upper GI endoscopy will be performed with a standard diameter tube, with SpO2 non invasive monitoring.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Strepsils + Xilocaine Spray Xilocaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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