Do Traditional or Flavored Tongue Depressors Make for Easier Posterior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- Does the use of a flavored tongue depressor decrease the patient's actual discomfort during a posterior oropharynx exam using the Oucher pediatric pain scale?
研究概览
简要总结
Evaluation of the oropharynx is a standard component of a general medical exam for all pediatric patients, but is an essential exam in the undifferentiated ill child. Pediatric patients are unable to verbalize where they hurt, and a comprehensive evaluation is needed to identify the source of fever and illness. Frequently, illnesses will present atypically as well, and a patient complaining of abdominal pain may ultimately be diagnosed with streptococcus pharyngitis. If the examiner does not evaluate the posterior oropharynx, the throat as a cause of abdominal pain is easily overlooked. Additionally, young children are prone to infections with pox viruses causing herpangina, hand foot and mouth disease, oral thrush. Despite the importance of the posterior oropharynx exam, it can be a source of stress and anxiety for both the clinician and pediatric patient when a tongue depressor is used to evaluate the posterior oropharynx. However, there are no studies to date that have looked at decreasing the difficulty or at decreasing the perceived discomfort associated with the poster oropharynx exam in the pediatric patient when a tongue depressor is utilized. Despite this paucity of research, there are multiple different flavored and candied tongue depressors available for this purpose which may or may not aid in obtaining posterior oropharynx exam and decrease the discomfort experienced by the patients.
详细描述
The study design is a prospective, placebo-controlled, randomized controlled trial using a convenience sample of 96 pediatric patients presenting for care in the emergency department who require an oropharyngeal examination as part of their evaluation. Examinations will be performed utilizing either traditional (unflavored) or flavored tongue depressors in a random fashion. . Physician/provider investigators will complete a brief survey after each exam as to the ease of the exam and the perceived emotional discomfort the exam experienced by the subject, both recorded on a visual analog scale. The age and sex of the subject, and the education level of the investigator will also be recorded. A single question survey will also be provided to the parent/caregiver as to their perception of the discomfort of their child during the posterior oropharynx exam using a visual analog scale. Additionally, a single question survey will be posed to the subject asking for their discomfort level during the exam using the Oucher pediatric pain scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Using a computer-generated simple randomization sequence in permuted blocks of 10, numbered study packets that include the surveys and tongue depressor will be prepared in advance. The packets, which will be prepared by a third party not participating in this research study, will include the information sheet, surveys for the investigator, participant and parent, all labeled with the sample number, and a tongue depressor within original packaging. The randomization key will be kept by the third party until the completion of data collection, at which time it will be given to the PI.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients between 3 and 12 years of age presenting to the emergency department who require the use of a tongue depressor to evaluate the posterior pharynx as part of their clinical evaluation.
排除标准
- •Patients who do not require a tongue depressor to fully examine the posterior oropharynx, patients who are immunocompromised and patients who are younger than 3 years of age or older than 12 years of age. We will also exclude patients with abnormal facies, and any patients with altered mental consciousness as defined by a GCS less than 15.
结局指标
主要结局
Does the use of a flavored tongue depressor decrease the patient's actual discomfort during a posterior oropharynx exam using the Oucher pediatric pain scale?
时间窗: Up to 12 months
次要结局
- Do flavored tongue depressors increase the ease of the posterior oropharynx exam in the pediatric patient by provider subjective assessment?(Up to 12 months)
- Does the use of a flavored tongue depressor decrease the perceived discomfort associated with pediatric posterior oropharynx exam as determined by the patient's caregiver?(Up to 12 months)
- Does the use of a flavored tongue depressor decrease the perceived discomfort associated with pediatric posterior oropharynx exam as determined by the provider subjective assessment?(Up to 12 months)
研究者
Brian P. Murray, DO
Senior Resident, Emergency Medicine
Brooke Army Medical Center