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

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ClinicalTrials.gov Identifier: NCT03620513
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Lumbini Medical College

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.

Condition or disease Intervention/treatment Phase
Throat Disorder Drug: Decongestant (oxymetazoline 0.05%) Drug: Anesthesia (Lidocaine 15%) Drug: Decongestants and Anesthesia (oxymetazoline and lidocaine) Drug: Normal saline Phase 4

Detailed Description:

Patient undergoing Fiberoptic laryngoscopy (FOL) will be randomized into five groups by block randomization. Group one will receive no pre-treatment and group two will receive atomized spray of normal saline as placebo before the procedure. Group three 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 four will receive two sprays of 15% lidocaine with a gap of 10 seconds in between the sprays. Group five will receive two sprays of oxymetazoline and then tow 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%, minimum sample size would be 34 in each group.

To reduce bias, all the procedure will be performed by senior consultants. Patients (except those not pre-medicated) 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Five arms of study group with equal number of subjects in each group
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pretreatment With Topical Anesthesia or Decongestant for Reducing Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy: A Double Blind Randomized Study
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No pre-medication
No pre-medication prior to fiberoptic procedure
Placebo Comparator: Normal Saline nasal spray
Two spray (via atomizer) of normal saline in each nostril five minutes prior to fiberoptic procedure
Drug: Normal saline
Spray of normal saline as premedication

Experimental: Decongestant (Oxymetazoline 0.05%)
Two sprays via atomizer (about 0.18 ml) of oxymetazoline 0.05% (Nasivion) in each nasal cavity five minutes prior to fiberoptic procedure. Two sprays will be given at the gap of ten seconds.
Drug: Decongestant (oxymetazoline 0.05%)
As described in arm/group
Other Name: Nasivion

Experimental: Anesthesia (lidocaine 15%, Nummit)
Two sprays of 15% lidocaine (Nummit) will be give in each nasal cavity five minutes prior to fiber optic procedure. Two sprays will be given at the gap of ten seconds.
Drug: Anesthesia (Lidocaine 15%)
As described in arm/group
Other Name: Nummit

Experimental: Decongestant and Anesthesia
In this group decongestants and anesthesia (oxymetazoline and lidocaine) sprays will be used. Decongestant (Oxymetazoline 0.05%) will be give as described above. After two minutes, lidocaine 15% (Nummit) spray will be given as described above. Procedure will be done after five minutes of decongestant.
Drug: Decongestants and Anesthesia (oxymetazoline and lidocaine)
As described in arm/group
Other Name: Nasivion and Nummit




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620513


Contacts
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Contact: Anup Acharya, MS +9779802625484 anupent@gmail.com

Locations
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Nepal
Lumbini Medical College Recruiting
Tansen, Palpa, Nepal, 32500
Contact: Anup Acharya, MS (ENT)    977 9802625484    anupent@gmail.com   
Sponsors and Collaborators
Lumbini Medical College
Investigators
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Principal Investigator: Anup Acharya, MS Associate Professor

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Responsible Party: Lumbini Medical College
ClinicalTrials.gov Identifier: NCT03620513     History of Changes
Other Study ID Numbers: 142
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized data via journal website or on request to the researcher
Supporting Materials: Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: As soon as article is published online. It will be available for good.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anesthetics
Lidocaine
Oxymetazoline
Phenylephrine
Ephedrine
Pseudoephedrine
Nasal Decongestants
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Vasoconstrictor Agents
Respiratory System Agents
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents
Central Nervous System Stimulants