Clinical trial NCT03620513: Pretreatment to Reduce Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy
Official title: Pretreatment With Topical Anesthesia or Decongestant for Reducing Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy: A Double Blind Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Throat Disorder
Lead sponsor: Lumbini Medical College
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four arms of study group with equal number of subjects in each group
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Discomfort of procedure (fiberoptic nasopharyngolaryngoscopy) as VAS 1-10
timeFrame: At the end of the procedure
Secondary outcomes:
measure: Discomfort of pre-treatment as VAS 1-10
timeFrame: four minutes from the first spray
measure: Prevalence of adverse effects of pre-medication
timeFrame: four minutes from the first spray
measure: Pain due to procedure as VAS 1-10
timeFrame: At the end of the procedure
measure: Ease of procedure as VAS 1-10
timeFrame: At the end of the procedure
measure: Prevalence of adverse effects of procedure
timeFrame: At the end of the procedure
measure: Likely to recommend (not likely, can not say, very likely)
timeFrame: At the end of the procedure
Other outcomes:
Locations:
city: Tansen
country: Nepal
facility: Lumbini Medical College
state: Palpa
Study officials:
affiliation: Associate Professor
name: Anup Acharya, MS
role: PRINCIPAL_INVESTIGATOR
References: