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Completed

NCT Number: NCT03620513

Pretreatment to Reduce Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lumbini Medical College

Tānsen, Palpa, 32500, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decongestant (oxymetazoline 0.05%)

Drug

As described in arm/group

Other names: Nasivion

Anesthesia (Lidocaine 15%)

Drug

As described in arm/group

Other names: Nummit

Decongestants and Anesthesia (oxymetazoline and lidocaine)

Drug

As described in arm/group

Other names: Nasivion and Nummit

normal saline

Drug

Spray of normal saline as premedication

Primary outcomes

  1. Discomfort of procedure (fiberoptic nasopharyngolaryngoscopy) as VAS 1-10

    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)

Secondary outcomes

  1. Discomfort of pre-treatment as VAS 1-10

    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)

  2. Prevalence of adverse effects of pre-medication

    Time frame: four minutes from the first spray

    allergy, burning pain, altered taste, chocking sensation, headache will be asked and recorded

  3. Pain due to procedure as VAS 1-10

    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)

  4. Ease of procedure as VAS 1-10

    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)

  5. Prevalence of adverse effects of procedure

    Time frame: At the end of the procedure

    bleeding, gag, nausea, vomiting will be noted

  6. Likely to recommend (not likely, can not say, very likely)

    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

Sponsors and collaborators

Lead sponsor

Lumbini Medical College

Other

Registry information

Official study title

Pretreatment With Topical Anesthesia or Decongestant for Reducing Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy: A Double Blind Randomized Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2018
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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