Throat Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDecongestant (oxymetazoline 0.05%)
As described in arm/group
DRUGAnesthesia (Lidocaine 15%)
As described in arm/group
DRUGDecongestants and Anesthesia (oxymetazoline and lidocaine)
As described in arm/group
DRUGNormal saline
Spray of normal saline as premedication
Sponsors
Lumbini Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Four arms of study group with equal number of subjects in each group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing fiberoptic naso pharyngo laryngoscopy in OPD setting * Consent to study * above 18 years
Exclusion criteria
* gross nasal mass * pregnants * known hypersensitivity to the drugs used for premedication * who cannot respond to questionnaire during data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort of procedure (fiberoptic nasopharyngolaryngoscopy) as VAS 1-10 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of adverse effects of pre-medication | four minutes from the first spray | allergy, burning pain, altered taste, chocking sensation, headache will be asked and recorded |
| Pain due to procedure as VAS 1-10 | 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) |
| Discomfort of pre-treatment as VAS 1-10 | 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) |
| Prevalence of adverse effects of procedure | At the end of the procedure | bleeding, gag, nausea, vomiting will be noted |
| Likely to recommend (not likely, can not say, very likely) | 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 |
| Ease of procedure as VAS 1-10 | 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) |
Countries
Nepal
Outcome results
None listed