Upper Gastrointestinal Endoscopy
Conditions
Brief 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.
Interventions
DRUGStrepsils 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.
DRUGXilocaine Spray Arm
After Xilocaine Spray pharyngeal topical anestesia, upper GI endoscopy will be performed with a standard diameter tube, with SpO2 non invasive monitoring.
Sponsors
Carol Davila University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction score | 24 hours | Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient discomfort score | 24 hours | Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum) |
| Patient pain score | 24 hours | Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum) |
| Patient gag score | 24 hours | Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum), by the endoscopist |
| Endoscopist satisfaction score | 24 hours | Evaluation on visual score 0 - 10 (0 - minimum, 10 - maximum) |
Countries
Romania
Outcome results
None listed