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

NCT03095183 | Completed FDA Device

• 1 other identifier: C.2016.146d
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oropharynx

Keywords

Posterior oropharynx exam; Pediatric; Tongue Depressor; Flavored Tongue Depressor

Outcome Measures

Primary Outcomes (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?

  Up to 12 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Traditional Tongue Depressor

PLACEBO COMPARATOR

The posterior oropharynx exam was performed with a traditional, unflavored Puritan Regular tongue depressor.

Device: Traditional unflavored Puritan Regular Tongue Depressor

Flavored Tongue Depressor

ACTIVE COMPARATOR

The posterior oropharynx exam was performed with a grape flavored, commercially available, Puritan Junior tongue depressor.

Device: Grape flavored Puritan Junior tongue depressor

Interventions

Grape flavored Puritan Junior tongue depressor DEVICE

Flavored Tongue Depressor

Traditional unflavored Puritan Regular Tongue Depressor DEVICE

Traditional Tongue Depressor

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, Emergency Medicine

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 29, 2017
• Study Start: August 24, 2016
• Primary Completion: February 21, 2017
• Study Completion: February 21, 2017
• Last Updated: March 29, 2017

Record last verified: 2017-03