Lumbini Medical College
Tānsen, Palpa, 32500, Nepal
NCT Number: NCT03620513
Fiberoptic laryngoscopy (FOL) is one of the most common procedure done in an Ear Nose Throat (ENT) clinic. Topical anesthesia or decongestant or both have been used to improve patient comfort level during the procedure. Recently, role of these agents has been questioned. The investigators would like to study whether topical anesthesia or decongestant or their combination provide any benefit to the patients undergoing FOL.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Tānsen, Palpa, 32500, Nepal
Patient undergoing Fiberoptic laryngoscopy (FOL) will be randomized into four groups by block randomization. Group one will receive atomized spray of normal saline as placebo before the procedure. Group two will receive two sprays of atomized oxymetazoline (approx 0.18 ml of 0.05% oxymetazoline) with a gap of 10 seconds in between the sprays. Group three will receive two sprays of 15% lidocaine with a gap of 10 seconds in between the sprays. Group four will receive two sprays of oxymetazoline and then two sprays of lidocaine at an interval of two minutes.
Sample size calculation: With alpha error of 0.05, power of .8, mean discomfort scale for placebo of 2.8 (literature review) and SD of 1.1, presuming that the treatment would be able to reduce discomfort by at least 25%, with two tailed test and same SD, minimum sample size would be 40 in each group.
To reduce bias, all the procedure will be performed by senior consultants. Patients and the person performing the procedure will be blinded.
Discomfort of pre-medication, discomfort of scope insertion, pain due to scope insertion, and ease of procedure will be scored as VAS score (1 to 10, 1 is least and 10 is most). Also, patient will be asked how likely s/he is to recommend the similar procedure to his/her friends and family members in case they need to undergo the same. Side effects of pre-medication and procedure will also be noted.
Outcome variables among the groups will be compared using ANOVA test if they are normally distributed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
As described in arm/group
Other names: Nasivion
As described in arm/group
Other names: Nummit
As described in arm/group
Other names: Nasivion and Nummit
Spray of normal saline as premedication
Time frame: At the end of the procedure
Discomfort will be scored as VAS on a scale of 1 to 10 (1 is least, 10 is most)
Time frame: four minutes from the first spray
Discomfort will be scored as VAS on a scale of 1 to 10 (1 is least, 10 is most)
Time frame: four minutes from the first spray
allergy, burning pain, altered taste, chocking sensation, headache will be asked and recorded
Time frame: At the end of the procedure
Pain will be scored as VAS on a scale of 1 to 10 (1 is least, 10 is most)
Time frame: At the end of the procedure
Ease will be scored as VAS on a scale of 1 to 10 (1 is least, 10 is most)
Time frame: At the end of the procedure
bleeding, gag, nausea, vomiting will be noted
Time frame: At the end of the procedure
Patient will be asked, "How likely you are to recommend this procedure to your relative in case they are advised to". It will be scored as 1-Not at all; 2-not sure; 3-Strongly recommend
Lumbini Medical College
Other
Pretreatment With Topical Anesthesia or Decongestant for Reducing Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy: A Double Blind Randomized Study
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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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