To investigate whether analgesic ear drops added to usual care (oral analgesics with/without antibiotics) provide superior ear pain relief over usual care in children presenting to primary care with ear pain and diagnosed with AOM .
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the mean parent-reported ear pain score over the first 3
days, using a 0-10 validated numerical rating scale.
Secondary outcome
Secondary outcomes include: proportion of children using antibiotics, oral
analgesic use and overall symptom burden in the first 7 days; number of days
with ear pain, number of GP reconsultations and subsequent antibiotic
prescribing, adverse events, complications of AOM and cost-effectiveness during
4-week follow-up; generic and disease-specific quality of life at 4 weeks;
parents* and GPs* views on treatment acceptability, usability and satisfaction
(nested mixed methods process evaluation).
Background summary
Acute otitis media (AOM) is a common childhood condition and a major cause of
primary care consultation and antibiotic prescribing. Ear pain is the most
prominent symptom of AOM. Evidence of effectiveness for interventions to
control the pain and reduce reliance on antibiotics is urgently needed.
Recently, we showed that introduction of an educational intervention to improve
pain management in children with AOM resulted in an increase in oral analgesic
use, but failed to impact on parent-reported ear pain or antibiotic use. A
UK-based trial run by study team members recently provided some evidence that
analgesic ear drops can reduce ear pain and antibiotic consumption in children
with AOM. This trial was closed early due to operational issues which leaves
the question on the effectiveness of these drops.
Study objective
To investigate whether analgesic ear drops added to usual care (oral analgesics
with/without antibiotics) provide superior ear pain relief over usual care in
children presenting to primary care with ear pain and diagnosed with AOM .
Study design
Pragmatic, two arm, individually randomised, open, superiority trial with
cost-effectiveness analysis and nested mixed methods process evaluation in
general practices in the Netherlands with a follow-up of 4 weeks.
Intervention
Children will be randomly allocated to either 1) Lidocaine ear drops (Otalgan®)
1-2 drops up to six times daily for a maximum of 7 days in addition to usual
care or 2) usual care.
Treatment decisions as per usual care, i.e. antibiotics and oral analgesics,
will be to the GP*s discretion in both groups. To those allocated to the
intervention group, the study physician will not provide any treatment advice
other than instructions about the use of analgesic ear drops.
Study burden and risks
All study participants will receive usual care. The potential benefits of study
participation for those randomly allocated to the intervention group are better
local symptom (ear pain) control and subsequently fewer repeat GP visits and
antibiotic use .
Lidocaine ear drops (Otalgan®) are widely available over-the-counter in the
Netherlands. These drops should not be used in children with a tympanic
membrane perforation or ventilation tube as they carry a risk of inner ear
damage causing hearing loss or tinnitus. These children will therefore be
excluded, as well as those with ear wax obscuring visualisation of the tympanic
membrane. Systemic exposure to lidocaine is very low when administered
topically to the ear. The only reported side-effect in the Summary of Product
Characteristics of Otalgan® is hypersensitivity reaction (rare; <1/1,000). We
therefore judge this study as having a negligible risk.
Universiteitsweg 100
Utrecht 3584 CG
NL
Universiteitsweg 100
Utrecht 3584 CG
NL
Listed location countries
Age
Inclusion criteria
- Age 1 to 6 years
- Parent-reported ear pain in 24 hours prior to enrolment
- GP-diagnosis of (uni- or bilateral) AOM
Exclusion criteria
Children:
- with (suspected) tympanic membrane perforation or ventilation tubes
- with ear wax obscuring visualisation of the tympanic membrane
- who are systemically very unwell or require hospital admission (e.g. child
has signs and symptoms of serious illness and/or complications such as
mastoiditis/meningitis).
- who are at high risk of serious complications including children with known
immunodeficiency other than partial IgA or IgG2 deficiencies, craniofacial
malformation including cleft palate, Down syndrome and previous ear surgery
(with the exception of ventilation tubes in the past).
- who have a known allergy or sensitivity to study medication or similar
substances (e.g. other amide-type anaesthetics, bupivacaine, mepivacaine,
prilocaine)
- who have taken part in any research involving medicines within the last 90
days, or any other AOM-related research within the last 30 days.
- who suffer from chronic recurrent pain of another origin than the ear.
- who have participated in this trial during prior AOM episode.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-003019-24-NL |
| Other | Netherlands Trial Register, ID: NL9500 |
| CCMO | NL77733.041.21 |