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

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ClinicalTrials.gov Identifier: NCT03095183
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Brian P. Murray, DO, Brooke Army Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oropharynx Device: Grape flavored Puritan Junior tongue depressor Device: Traditional unflavored Puritan Regular Tongue Depressor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All patients registered for evaluation in the Brooke Army Medical Center Pediatric Emergency Department will be screened by evaluation of age, mental status, physical features and history of immunocompromised by the PI or AI as part of their standard triage and care procedures for their evaluation and treatment in the Emergency Department. Potential participants will be identified by the PI and AI from patients who are registered to be seen by the PI or AI. Potential participants who meet the inclusion criteria and who have none of the exclusion criteria will be approached prior to completion of the posterior oropharynx exam for permission to enroll them in this study.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Device Feasibility
Official Title: Do Traditional or Flavored Tongue Depressors Make for Easier Posterior
Actual Study Start Date : August 24, 2016
Actual Primary Completion Date : February 21, 2017
Actual Study Completion Date : February 21, 2017

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Responsible Party: Brian P. Murray, DO, Senior Resident, Emergency Medicine, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT03095183     History of Changes
Other Study ID Numbers: C.2016.146d
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Brian P. Murray, DO, Brooke Army Medical Center:
Posterior oropharynx exam
Pediatric
Tongue Depressor
Flavored Tongue Depressor