Inhaled Glucocorticoids for Acute Pharyngitis: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Number of participants with the complete resolution of sore throat after 24hours from intervention.
研究概览
简要总结
Background: Acute pharyngitis (AP) is a common presentation to the Emergency Department (ED). Most AP patients' who present to the ED are interested in relief their sore throat (pain). There are different approaches available in the literature to control AP pain. Studies have shown that the use of systemic glucocorticoids significantly decreases patients' sore throat. Up to our knowledge, there are no available trials looking at the role of nebulized glucocorticoids in treating infective AP.
Aim: Our aim is to investigate in pediatrics and adults population ≥5 years presenting to ED with AP if the use of a single dose of nebulized glucocorticoids as an adjunct to standard AP treatment, compared with placebo leads to complete resolution or improvement in symptoms.
Method: The investigators are planning to conduct a multi-center, double-blind randomized control trial. There will be three arms; first arm: nebulized Budesonide, second arm: nebulized Dexamethasone and third arm: placebo nebulized Normal Saline (NS). The patients will be followed up for 7 days through phone calls to assess the primary and secondary outcomes. Our primary objective is to investigate whether the use of a single dose of nebulized glucocorticoids compared with placebo leads to significant improvement or complete resolution of the sore throat within 24hrs. Our secondary objectives are to assess if a single dose of glucocorticoids will: reduce sore throat at 48 hours, reduce absence from work or school, reduce the incidence of hospital admission, and reduce the rate of re-attendance to ED. Since there is no available data about the effect of nebulized glucocorticoids in AP, the appropriate sample size will be calculated after running a pilot study. The data will be recorded in the EpiData@ software. Then the data will be analyzed using the SPSS@ software. The ethical approval was sought from the ethical committee in each participating hospital and they approved it.
Results: The result of this study will be presented in local conferences as well in international conferences. The investigators will aim to publish the study in a well-known international emergency medicine journal.
Clinical application: up to our knowledge this study is the first study worldwide looking at the effect of nebulized glucocorticoids in patients with infective acute pharyngitis. As mentioned earlier that there are multiple approaches available in the literature to control sore throat pain and if our hypothesis turned to be correct then another alternative treatment can be added. The investigators believe that the use of topical route to administer glucocorticoids is more convenient for physicians and have less chance to develop adverse effect in comparison to systemic steroids.
详细描述
Introduction:
Acute pharyngitis (AP) is a commonly diagnosed condition in the Emergency Departments (ED). In the United States (USA), there are approximately 12 million visits to health institutions due to acute pharyngitis(1). It is defined as an acute inflammation of the pharynx and/or tonsils and the diagnosis is made clinically(2). Although there are variable etiologies for AP, viral infections are the commonest(3). Symptoms of AP vary in the severity but the most common symptom for which the patients seek medical care is a sore throat. The patient may complain of fever, flu symptoms, odynophagia (painful swallowing), neck pain, poor oral intake, nausea, and vomiting. Of these symptoms, around 80% of patients with AP were interested more to relieve their pain(4).
Different approaches were suggested to control AP pain. It is well established that oral acetaminophen and ibuprofen are effective in decreasing AP pain(5). Different forms of topical therapies like lozenges/drops, throat sprays, gargles, and teas are also available for relief AP related pain. There is no evidence that a particular topical lozenge or spray is superior in efficacy(6).
Systemic glucocorticoids have been proven to be effective in decreasing AP sore throat. Systemic reviews and meta-analysis studies showed that a single dose of systemic glucocorticoids decreases pain within 24 hours by two times and at 48 hours by 1.5 times(7) (8) compared to patients who didn't receive steroids. A recently published trial showed that the use of systemic glucocorticoids in less severe acute pharyngitis significantly result in complete resolution of a sore throat at 48hours(9).
Glucocorticoids are commonly used medication in the emergency department. They have a very good safety profile(10). A short course of glucocorticoids is less likely to result in adverse events (AE) and if occurred usually with systemic, not with local glucocorticoids(10). Studies have shown that the use of a single dose of systemic glucocorticoids for acute pharyngitis did not result in significant adverse events and no serious adverse events were reported (7) (8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatrics and adult > 5 years of age
- •Patients complain of acute sore throat likely due to infective pharyngitis/tonsillitis as judged by the treating clinician.
- •Onset of symptoms within 7 days
- •Patient or caregiver has the capacity and willingness to give consent and complete the trial paperwork, including the symptom diary.
- •Not on antibiotics for AP.
排除标准
- •Pregnant or lactating mother.
- •Recent use of oral or inhaled steroids within 7 days.
- •Presence of an alternative diagnosis e.g. pneumonia, croup, bronchiolitis,
- •Known immune-deficiency (e.g. HIV, active chemotherapy or advanced cancer)
- •Complicated acute sore throat that hospital admission is required (e.g. completely unable to swallow, very systemically unwell, or peritonsillar abscess)
- •Presence of clear contraindication for steroids use (refer to the British National Formulary (BNF) list of contraindications)
- •Requirement for the live vaccine in the next 7 days.
研究组 & 干预措施
Budesonide
Drug Name: budesonide Dose: 2000mcg (2mg) of budesonide nebulizer solution is mixed with normal saline solution to make a total volume of 8mL.
Frequency: Stat Dose Route: Nebulization
干预措施: Budesonide 0.25 MG/ML Inhalant Solution (Drug)
Dexamethasone
Drug Name: Dexamethasone Sodium phosphate Dose: 8mg of IV formula of dexamethasone is mixed with normal saline to make a total volume of 8ml.
Frequency: Stat Dose Route: Nebulization
干预措施: Dexamethasone (Drug)
Control
Drug Name: Normal Saline Dose: 8ml. Frequency: Stat Dose Route: Nebulization
干预措施: Normal saline (Drug)
结局指标
主要结局
Number of participants with the complete resolution of sore throat after 24hours from intervention.
时间窗: 24 hours after intervention.
Direct report by the patient of presence or absence of complete resolution of sore throat at 24 hours by telephone.
次要结局
- Average number of days of absences from work among participants.(7 days after intervention.)
- Number of participants with the complete resolution of sore throat after 48 hours from intervention.(48 hours after intervention.)
- Number of hours needed until the onset of pain relief.(7 days after intervention.)
- Number of hours needed until complete resolution of sore throat.(7 days after intervention.)
- Number of participants reattended the Emergeancy Department (ED) due to acute pharyngitis.(7 days after intervention.)
- Number of participants developed complications related to acute pharyngitis.(7 days after intervention.)
研究者
Al Yaqdhan Al Atbi
Emergency Medicine Specialist
Royal Oman Police Hospital