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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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)|
|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|
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
- 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)
- 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)
- 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
- 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)
- 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)
- Prevalence of adverse effects of procedure [ Time Frame: At the end of the procedure ]bleeding, gag, nausea, vomiting will be noted
- 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
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
|Contact: Anup Acharya, MSfirstname.lastname@example.org|
|Lumbini Medical College||Recruiting|
|Tansen, Palpa, Nepal, 32500|
|Contact: Anup Acharya, MS (ENT) 977 9802625484 email@example.com|
|Principal Investigator:||Anup Acharya, MS||Associate Professor|