NCT Number: NCT03095183
Do Traditional or Flavored Tongue Depressors Make for Easier Posterior Oropharynx Exams in Pediatric Patients
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
3 year–12 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
Traditional unflavored Puritan Regular Tongue Depressor
DevicePrimary outcomes
-
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?
Time frame: Up to 12 months
Secondary outcomes
-
Do flavored tongue depressors increase the ease of the posterior oropharynx exam in the pediatric patient by provider subjective assessment?
Time frame: 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?
Time frame: 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?
Time frame: Up to 12 months
Sponsors and collaborators
Lead sponsor
Brooke Army Medical Center
Fed
Registry information
Official study title
Do Traditional or Flavored Tongue Depressors Make for Easier Posterior
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Mar 29, 2017
- Registry last updated
- Mar 29, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
PuraBond® and Pain Following Resection of Oral or Oropharyngeal Mucosal Lesions
NCT05773781
Hemorrhage, Hemostatics
Liverpool, United Kingdom
View Trial DetailsEx Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
NCT01321892
Carcinoma, Carcinoma, Squamous Cell
New York, United States
View Trial DetailsPhase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
NCT06223568
Cancer Vaccine, Carcinoma
Bethesda, Maryland, United States
View Trial Details