Pain, Satisfaction, Patient
Conditions
Keywords
lidocaine spray, lidocaine solution, non-sedating EGD
Brief summary
This study aimed to compare the efficacy of lidocaine spray (S) alone versus lidocaine spray combined with lidocaine viscous solution (S+V) in facilitating pharyngeal observation during Non-sedating upper gastrointestinal endoscopy (UGE).
Detailed description
A randomized controlled trial was conducted between July and October 2023 at Sawanpracharak hospital, Thailand. Of 250 patients undergoing UGE, 125 were randomly assigned to group S (lidocaine spray alone) and 125 to group S+V (lidocaine spray plus lidocaine viscous solution). The total dose of lidocaine did not exceed 5 mg/kg in both groups
Interventions
DRUGLidocaine Spray
Pharyngeal anesthesia using a topical lidocaine spray was administered in the preprocedure room, in the absence of the endoscopist or the research assistant. 5 minute before the UGE without any sedation
DRUGLidocaine Viscous+Lidocane spray
Pharyngeal anesthesia using topical viscous lidocaine solution + lidocaine spray were administered in the preprocedure room, in the absence of the endoscopist or the research assistant. 5 minute before the UGE without any sedation
Sponsors
Sawanpracharak hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for upper gastrointestinal endoscopy: * Patients who are robust, without chronic illnesses, or with controlled chronic conditions that do not adversely affect the function of any organ (American Society of Anesthesiologists (ASA) physical status classification I-II).
Exclusion criteria
* Has a history of receiving painkillers or sleeping pills within 24 hours before the endoscopy. * Has a history of post-endoscopy nausea and vomiting. * Patients who have undergone upper gastrointestinal endoscopy previously. * Has chronic conditions such as epilepsy, vertigo, or mental health disorders. * Has a history of allergy to anesthesia used in the study. * Pregnant or currently breastfeeding. * Refuses to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| procedural pain, measured using the visual analog scale (VAS). | 30 minute after finished precedure | The procedural pain was evaluated using a visual analog scale (VAS, 0-10) with 0 being none and 10 being the most painfull |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient tolerance | immediately after finished precedure | 1 = exceptional; 2 = well; 3 = fair; 4 = poor answer by endoscopist |
| endoscopist satisfaction | immediately after finished precedure | 1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied |
| patient satisfaction | 30 minute after finished precedure | 1 = very satisfied; 2 = satisfied; 3 = neutral; and 4 = dissatisfied |
Countries
Thailand
Outcome results
None listed