Children's drops for ear pain in acute otitis media: the CEDAR randomised controlled trial

Not Applicable

Completed

• Conditions: Acute otitis media in children; Ear, Nose and Throat

• Registration Number: ISRCTN09599764
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31304912 (added 16/07/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-02
• Study Completion: 2017-12-31
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Randomised Controlled Trial:
1. Children presenting within 72 hours of suspected AOM onset (other preceding respiratory tract infection symptoms may be longer)
2. Legal guardian (hereon parent) available to give immediate verbal (telephone) and written (within 24 hours) consent
3. Parent-reported ear pain in 24 hours pre-enrolment (unless child too young to report pain, when GP-ascertained otoscopic evidence alone sufficient)
4. GP-ascertained otoscopic evidence of acute inflammation (operationalised as per our previous trial6 as: dullness or cloudiness with erythema; or bulging)
5. Clinician willing to use a NICE recommended no or delayed antibiotic strategy
6. Parent able to give ear drops
7. Parent willing to able to complete symptom diary
8. Parent willing and available to receive follow-up telephone calls within first three days and at one week post recruitment

Children with cystic fibrosis (CF) and severe learning difficulties will be included, to maintain generalizability. We are not aware of evidence that AOM is different in children with CF, and the treating clinician will be responsible for deciding if children are safe to receive delayed antibiotics. Parents will be able to complete pain scores for children with severe learning difficulties.

Observational Cohort Study:
1. Children presenting within 72 hours of suspected AOM onset (other preceding respiratory tract infection symptoms may be longer)
2. Legal guardian (hereon parent) available to give immediate verbal (telephone) and written (within 24 hours) consent
3. Parent-reported ear pain in 24 hours pre-enrolment (unless child too young to report pain, when GP-ascertained otoscopic evidence alone sufficient)
4. GP-ascertained otoscopic evidence of acute inflammation (operationalised as per our previous trial) as: dullness or cloudiness with erythema; or bulging)
5. Parent willing to able to complete symptom diary
6. Parent willing and available to receive follow-up telephone calls within first three days and at one week post recruitment

Exclusion Criteria

Randomised Controlled Trial:
1. Requirement for immediate oral antibiotic for AOM (e.g. NICE recommend for children under 2 years with bilateral AOM or otorrhoea) or another infection
2. Alternative source of pain
3. GP-ascertained otoscopic appearances consistent with fever or crying (pink drum alone)
4. Diagnosis more suggestive of otitis media with effusion (glue ear)
5. Suspected or confirmed perforation (theoretical but unconfirmed risk of ototoxicity from active drops, seen in 7% of children with AOM5)
6. Known sensitivity to study medicine; child requiring immediate hospitalisation

Observational Cohort Study:
None

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any antibiotic consumed by day 7 (measured using symptom diary and telephone call at 1 week)