Do Traditional or Flavored Tongue Depressors Make for Easier Posterior Oropharynx Exams in Pediatric Patients

Do Traditional or Flavored Tongue Depressors Make for Easier Posterior

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.

Study Overview

• Status: Completed
• Conditions: Oropharynx
• Intervention / Treatment: Device: Traditional unflavored Puritan Regular Tongue Depressor; Device: Grape flavored Puritan Junior tongue depressor

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Traditional Tongue Depressor; The posterior oropharynx exam was performed with a traditional, unflavored Puritan Regular tongue depressor.	Device: Traditional unflavored Puritan Regular Tongue Depressor
Active Comparator: Flavored Tongue Depressor; The posterior oropharynx exam was performed with a grape flavored, commercially available, Puritan Junior tongue depressor.	Device: Grape flavored Puritan Junior tongue depressor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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?	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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

Collaborators and Investigators

• Sponsor: Brooke Army Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2016
• Primary Completion (Actual): February 21, 2017
• Study Completion (Actual): February 21, 2017

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Pediatric; Posterior oropharynx exam; Tongue Depressor; Flavored Tongue Depressor
• Other Study ID Numbers: C.2016.146d

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No