Pretreatment to Reduce Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy
Study Details
Study Description
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 |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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)
- 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)
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lumbini Medical College | Tansen | Palpa | Nepal | 32500 |
Sponsors and Collaborators
- Lumbini Medical College
Investigators
- Principal Investigator: Anup Acharya, MS, Associate Professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 142