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OpenTrials
Completed

NCT Number: NCT06220175

Pharynx Analgesia Before Upper Gastrointestinal Endoscopy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Agrippa Ionescu" Hospital

Bucharest, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strepsils Intensiv plus Xilocaine spray Arm

Drug

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

Other names: Strepsils + Xilocaine Spray

Xilocaine Spray Arm

Drug

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

Primary outcomes

  1. Patient satisfaction score

    Time frame: 24 hours

    Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)

Secondary outcomes

  1. Patient discomfort score

    Time frame: 24 hours

    Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)

  2. Patient pain score

    Time frame: 24 hours

    Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)

  3. Patient gag score

    Time frame: 24 hours

    Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum), by the endoscopist

  4. Endoscopist satisfaction score

    Time frame: 24 hours

    Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum)

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Acronym: PHRASE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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