Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?

NCT01941381 | Completed

• 1 other identifier: Pro00040754
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Due to recent efforts to decrease antibiotic overuse, and reports of high rates of spontaneous resolution for clinically diagnosed Acute Otitis Media(AOM), most physicians now wait 48-72 hours before starting antibiotics for common ear infections. The investigators are interested to see if those patients with documented middle ear effusions, as determined by tympanometry, have higher rates of eventual antibiotic usage than those with normal tympanometry results. If there is a significant disparity between those with a positive tympanogram and those without the investigators may be able to identify a group that will benefit from antibiotics and a group that would not need treatment.

Conditions

Acute Otitis Media

Keywords

Otitis Media; Tympanometry

Outcome Measures

Primary Outcomes (1)

• Are those children aged 6 months to 16 years who attend the Emergency Department and diagnosed with AOM more likely to fill a prescription for antibiotics over the next 7 days if their tympanogram is type B rather than types A or C?

  Follow-up phone calls will be made to families to determine antibiotic usage. This will be confirmed by accessing the provincial pharmacy database.

  8 days post-enrollment

Secondary Outcomes (6)

• Does a type B tympanogram increase reported pain?

  3 and 8 days post enrollment

• Does a type B tympanogram predict increased analgesic usage?

  3 and 8 days post enrollment

• Does a type B tympanogram predict amount of fever?

  3 and 8 days post enrollment

• Does a type B tympanogram predict increased sleep disturbance?

  3 and 8 days post enrollment

• Does a type B tympanogram predict amount of oral intake?

  3 and 8 days post enrollment

Study Arms (2)

Type B tympanogram

Patients with a clinical diagnosis of acute otitis media and a B type curve with tympanometry.

Procedure: Tympanometry

Type A/C tympanogram

Patients with a clinical diagnosis of acute otitis media and a type A or C curve with tympanometry

Procedure: Tympanometry

Interventions

Tympanometry PROCEDURE

All patients enrolled with receive a tympanogram. There will be no difference between the follow up in the groups based on the tympanometry results. The study is simply observational

Type A/C tympanogram; Type B tympanogram

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children, aged 6 months to 16 years, with clinically diagnosed Otitis Media in the Pediatric Emergency Department of the University of Alberta Hospital, in whom the clinician decides to adopt a delayed antibiotic strategy (ie a period of 48-72H observation with antibiotics given only if symptoms are not resolving).

You may qualify if:

• Clinical diagnosis of Acute Otitis Media
• Clinician decision to adopt a delayed antibiotic treatment strategy

You may not qualify if:

• Antibiotics within previous 2 weeks
• Immunosuppressive Medication or Condition
• Perforated Otitis Media
• Previous complications secondary to Otitis Media

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Andrew C Dixon, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• William R Craig, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

CA (1)