The Children's Ear Pain Study (Ear drops for ear pain in children with acute middle ear infection)

Phase 1

• Conditions: Acute otitis media; MedDRA version: 20.0Level: PTClassification code 10014020Term: Ear painSystem Organ Class: 10013993 - Ear and labyrinth disorders; MedDRA version: 20.1Level: PTClassification code 10065838Term: Middle ear inflammationSystem Organ Class: 10013993 - Ear and labyrinth disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2014-004016-11-GB
• Lead Sponsor: niversity of Bristol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-07
• Study Completion: 2019-03-19
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Trial inclusion criteria (all criteria must be met):
1)Aged = 12 months and <10 years
2)Presenting within 1 week of suspected AOM onset (other preceding respiratory tract infection symptoms may be longer)
3)Parent/legal guardian available to give consent
4)Parent-reported ear pain in 24 hours pre-enrolment (or parent-suspected ear pain if child is too young to report pain)
5)Clinician diagnosis of acute otitis media (although not an entry criterion, clinicians will be asked to report the presence of otoscopic evidence of acute tympanic membrane inflammation, operationalised as per our previous trial6 as: erythema with dullness or cloudiness; or bulging)
6)Child is immunocompetent
7)Clinician willing to use a NICE-recommended ‘no’ oral antibiotic prescribing strategy or a ‘delayed’ oral antibiotic prescribing strategy (as per NICE guidelines) for the AOM and other elements of the underlying acute respiratory tract infection. NICE recommends a ‘no’ or ‘delayed’ antibiotic prescribing strategy for most immune-competent children with acute otitis media.
8)Parent able to give ear drops.
9)Parent willing in principle to use ear drops before oral antibiotics and to wait before giving delayed antibiotics as per NICE guidelines.
10)Parent able to report the child’s ear pain.
11)Parent able and willing to complete daily Symptom and Recovery Questionnaire in the English language, and receive regular follow-up telephone calls, in the English language, today and every 2-3 days for up to 7 more days (or until child has been free of ear pain without medicines for two days running).

Observational study inclusion criteria (all criteria must be met):
1)Aged =12 months to <10 years
2)Presenting within 1 week of suspected AOM onset (other preceding respiratory tract infection symptoms may be longer)
3)Parent/legal guardian available to give immediate written or (if not present) telephone consent, and to provide written consent within 24 hours
4)Parent-reported ear pain in 24 hours pre-enrolment (or parent-suspected pain if child too young to report pain)
5)Clinician diagnosis of acute otitis media (although not an entry criterion, clinicians will be asked to report the presence of otoscopic evidence of acute tympanic membrane inflammation, operationalised as per our previous trial6 as: erythema with dullness or cloudiness; or bulging)
6)Child is immunocompetent.
7)Parent does not want to use trial ear drops (reason to be recorded).
8)Parent does not want to take part in the RCT (reason to be recorded).
9)Parent able to report the child’s ear pain.
10)Parent able and willing to complete daily Symptom and Recovery Questionnaire in the English language, and receive regular follow-up telephone calls, in the English language, today and every 2-3 days for up to 7 more days (or until child has been free of ear pain without medicines for two days running)

Are the trial subjects under 18? yes
Number of subjects for this age range: 501
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Trial exclusion criteria (presence of any warrants exclusion):
1)Child requires immediate hospitalisation
2)Child requires same day oral antibiotic treatment for AOM or other elements of the underlying acute respiratory tract infection (assess these children for observational study eligibility). NICE recommends same day antibiotic treatment for:
2.1) Child younger than 2 years with bilateral acute otitis media
2.2) Otorrhoea (discharge from the ear)
2.3) Child systemically very unwell or showing signs of respiratory distress (e.g. tachypnoea, hypoxia or recession)
2.4) Child has symptoms and signs suggestive of serious illness and/or complications (particularly mastoiditis)
2.5) Child is at high risk of serious complications because of pre-existing comorbidity. NICE guidelines recommend the following children are excluded:
2.5.1) Child has significant heart, lung, renal, liver or neuromuscular disease (defined for the purposes of this study as requiring ongoing inpatient or outpatient care from specialist teams)
2.5.2) Child has immunosuppression (defined for the purposes of this study as a formal diagnosis of immunosuppression)
2.5.3) Child has cystic fibrosis
2.5.4) Child born prematurely (defined for the purposes of this study as born before 34 weeks and presenting within the first year of life)
NB: Children with other conditions who are at higher risk of AOM (e.g. Down’s Syndrome, cleft palate) may take part if the Responsible Clinician feels that they meet the inclusion criteria above)
3)Child requires same day oral antibiotics for another (non AOM) infection or topical antibiotic ear drops
4)Child is currently receiving (or has received in the past 7 days) oral or ear drop (to the AOM ear) antibiotic treatment
5)Suspected or confirmed tympanic membrane perforation (due to theoretical and unconfirmed risk of ototoxicity from active drops) or grommets still in situ
6)Known sensitivity to trial medicine (Auralgan) or to its ingredients (benzocaine, phenazone, glycerine, hydroxyquinoline sulphate) or similar substances (e.g. other ester-type anaesthetics such as procaine, tetracaine)
7)Known porphyria or haemoglobinopathy or glucose-6-phosphate dehydrogenase (G6PD) deficiency or methaemoglobinaemia
8)Known family history of G6PD deficiency (noting that G6DP deficiency is more common in African, Asian and Mediterranean populations)
9)Current use of sulphonamides or antimalarials or hyaluronidase or St John’s Wort
10)Child needs to continue taking other medicinal products containing benzocaine
11)Child has proven alternative source(s) of pain, other than and more severe than the ear symptoms with which they are presenting
12)Otoscopic appearances (as ascertained by clinician, where possible) consistent with observed fever, i.e. likely non-specific viral illness only (e.g. with just a slightly perfused or pink drum only)
13)Child has normal ear drum on examination
14)Child has otitis externa or other disorder of the outer ear or tympanic membrane, for which CEDAR ear drops should not be prescribed, in the AOM ear
15)Child has a hearing aid and parent feels hearing aid should remain in place in the AOM ear
16)Symptoms (i.e. hearing loss and longer duration of illness) more suggestive of a diagnosis of otitis media with effusion (glue ear)
17)Child has previously taken part in the CEDAR RCT
18)Child has taken part in any research involving medicines within the last 90 days, or any other AOM-related research within the

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified