Pretreatment With Topical Anesthesia or Decongestant for Reducing Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy: A Double Blind Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Discomfort of procedure (fiberoptic nasopharyngolaryngoscopy) as VAS 1-10
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing fiberoptic naso pharyngo laryngoscopy in OPD setting
- •Consent to study
- •above 18 years
排除标准
- •gross nasal mass
- •pregnants
- •known hypersensitivity to the drugs used for premedication
- •who cannot respond to questionnaire during data collection
研究组 & 干预措施
Normal Saline nasal spray
Two spray (via atomizer) of normal saline in each nostril five minutes prior to fiberoptic procedure
干预措施: Normal saline (Drug)
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.
干预措施: Decongestant (oxymetazoline 0.05%) (Drug)
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.
干预措施: Anesthesia (Lidocaine 15%) (Drug)
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.
干预措施: Decongestants and Anesthesia (oxymetazoline and lidocaine) (Drug)
结局指标
主要结局
Discomfort of procedure (fiberoptic nasopharyngolaryngoscopy) as VAS 1-10
时间窗: 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)
次要结局
- Discomfort of pre-treatment as VAS 1-10(four minutes from the first spray)
- Prevalence of adverse effects of pre-medication(four minutes from the first spray)
- Pain due to procedure as VAS 1-10(At the end of the procedure)
- Ease of procedure as VAS 1-10(At the end of the procedure)
- Prevalence of adverse effects of procedure(At the end of the procedure)
- Likely to recommend (not likely, can not say, very likely)(At the end of the procedure)