Acute Otitis MediaPhase 3OPTIMANCT05651633
Analgesic Ear Drops for Children With Acute Otitis Media
A Phase 3 study testing lidocaine hydrochloride 5mg/g in people with Acute Otitis Media and Pain, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Acute Otitis Media, Pain
- What is being tested?
- lidocaine hydrochloride 5mg/g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Oct 2021to 10 Jan 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 1 to 6 years
- Parent-reported ear pain in 24 hours prior to enrolment
- GP-diagnosis of (uni- or bilateral) AOM
Who cannot join
- 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, etc)
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
About this study
Official title: Effectiveness of Analgesic Ear Drops as add-on Treatment to Oral Analgesics in Children With Acute Otitis Media: a Pragmatic Randomised Controlled Trial
This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM. Children will be randomly allocated (ratio 1:1) to either 1) lidocaine hydrochloride 5mg/g ear drops (Otalgan) 1-2 drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics, with/without antibiotics) or 2) usual care. Parents will complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life questionnaires at baseline and 4 weeks. The primary outcome is the parent-reported ear pain score (0-10) over the first 3 days.
NOTE:
At the time of publication of the study protocol paper, the investigators were unable to make any amendments to the trial registration record in the Netherlands Trial Register (NTR) (NL9500; date of registration: 28 May 2021). The addition of a data sharing plan was required to adhere to the International Committee of Medical Journal Editors (ICMJE) guidelines. The investigators therefore re-registered the trial in ClinicalTrials.gov. This second registration is for modification purposes only and the NTR record (NL9500) should be regarded as the primary trial registration.
- Conditions
- Acute Otitis Media, Pain
- Being tested
- lidocaine hydrochloride 5mg/g
- Medical subject headings
- Otitis Media, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine hydrochloride 5mg/gDrug
Also called Otalgan
1-2 drops up to six times daily for a maximum of 7 days
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine ear drops with usual care | Experimental | usual care: oral analgesic with/without antibiotics Receives: Drug: lidocaine hydrochloride 5mg/g |
| usual care | No intervention | usual care: oral analgesic with/without antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Parent-reported Ear Pain Score Over the First Three Days
Parents will record their child's ear pain scores during the first three consecutive days using a 0-10 validated numerical rating scale. Higher scores indicate greater severity.
Measured: 3 days
Secondary outcomes (11)
Proportion of Children Consuming Antibiotics
proportion of children consuming antibiotics during first 7 days
Measured: in the first 7 days
Proportion of Children With Oral Analgesic Use
proportion of children with oral analgesic use during first 7 days
Measured: in the first 7 days
Overall Symptom Burden (Crying/Distress, Disturbed Sleep, Interference With Normal Activity, Appetite, Fever and Hearing Problems) Using a 0-6 Likert Scale
overall symptom burden (crying/distress, disturbed sleep, interference with normal activity, appetite, fever and hearing problems) using a 0-6 Likert scale with higher scores indicate greater severity
Measured: in the first 7 days
Number of Days With Ear Pain
Number of days with pain score of 1 or greater on a scale of 0-10, where higher scores indicate greater pain".
Measured: during follow up (4 weeks)
Number of GP Reconsultations With/Without Subsequent Antibiotic Prescribing
Measured: during follow-up (4 weeks)
Number of Participants With Adverse Events
Proportion of participants experiencing adverse events during follow-up
Measured: during follow-up (4 weeks)
Number of Participants With Complications of AOM
Measured: during follow-up (4 weeks)
Generic Quality of Life of the Child Assessed Using the 47-item Short-form of the Infant Toddler Quality of Life Questionnaire (ITQOL-SF47)
The questionnaire consists of 47 items in the following areas: overall health, physical abilities, growth and development, pain, temperament and moods, behavior, general health, parental emotional impact, parental time impact, and family cohesion. Scale for each area: from 0 (worst health) to 100 (best health)
Measured: At 4 weeks
Disease-specific Quality of Life of the Child Assessed Using the Otitis Media-6 (OM-6) Questionnaire
The 6 questions measure Physical Suffering, Hearing Loss, Speech Impairment, Emotional Distress, Activity Limitations, and Caregiver Concerns. Responses for each item were scored from 1 to 7 (1=Not present/no problem; 2=Hardly a problem at all; 3=Somewhat of a problem; 4=Moderate problem; 5=Quite a bit of a problem; 6=Very much of a problem; 7=Extreme problem). The OM Total score was calculated by adding all 6 items scores, resulting in a score ranging from 6-42. Higher scores of all six items indicate greater severity and impact of OM on the child's QOL.
Measured: At 4 weeks
Costs
Mean costs per patient will be compared across the randomisation groups
Measured: during follow-up (4 weeks)
Incremental Cost-effectiveness Ratios; Calculated by Dividing the Estimated Differences in Costs Between Groups by the Differences in Effects Observed
i.e. the additional cost per additional 1 point reduction in mean ear pain score over the first three days for the analgesic ear drops group versus the usual care group
Measured: during follow-up (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start6 Oct 2021
- Primary completion16 Dec 2023
- Study completion10 Jan 2024
Why it stopped: Trial accrual problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pragmatic, two arm, individually randomised, open, superiority trial
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roderick P. Venekamp, UMC Utrecht
- Investigators
- Roderick Venekamp, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651633
- Sponsor's protocol ID
- 80-87200-98-1017
- Other IDs
- NL9500, 10060011910003, 2021-003019-24
- Acronym
- OPTIMA
- Status last verified
- Jul 2026
- First submitted
- 9 Nov 2022
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On completion of the trial, data will be stored for a minimum of 25 years at a central data drive at the Julius Center. The investigators will publish the metadata in the DataverseNL repository and will provide a persistent identifier. The data will be available to researchers who provide a methodologicaly sound proposal to achieve the aims in the approved proposal. Proposals to gain access to the data should be directed to the principle investigator (RPV). Data requestors will need to sign a data sharing agreement.
Publications
de Sevaux JLH, Damoiseaux RAMJ, Hullegie S, Sanders EAM, de Wit GA, Zuithoff NPA, Yardley L, Anthierens S, Little P, Hay AD, Schilder AGM, Venekamp RP. Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: study protocol of the OPTIMA pragmatic randomised controlled trial. BMJ Open. 2023 Feb 22;13(2):e062071. doi: 10.1136/bmjopen-2022-062071.
PubMed 36813504
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Analgesic Ear Drops as add-on Treatment to Oral Analgesics in Children With Acute Otitis Media: a Pragmatic Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05651633
- Acronym / sponsor ID
- OPTIMA / 80-87200-98-1017
- Conditions
- Acute Otitis Media, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial accrual problems
- Enrolment
- 29 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 16 Dec 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Posted 16 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM. Children will be randomly allocated (ratio 1:1) to either 1) lidocaine hydrochloride 5mg/g ear drops (Otalgan) 1-2 drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics, with/without antibiotics) or 2) usual care. Parents will complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life questionnaires at baseline and 4 weeks. The primary outcome is the parent-reported ear pain score (0-10) over the first 3 days.
NOTE:
At the time of publication of the study protocol paper, the investigators were unable to make any amendments to the trial registration record in the Netherlands Trial Register (NTR) (NL9500; date of registration: 28 May 2021). The addition of a data sharing plan was required to adhere to the International Committee of Medical Journal Editors (ICMJE) guidelines. The investigators therefore re-registered the trial in ClinicalTrials.gov. This second registration is for modification purposes only and the NTR record (NL9500) should be regarded as the primary trial registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pragmatic, two arm, individually randomised, open, superiority trial
| Arm | Type | Receives |
|---|---|---|
| Lidocaine ear drops with usual care | Experimental | Drug: lidocaine hydrochloride 5mg/gusual care: oral analgesic with/without antibiotics |
| usual care | No intervention | –usual care: oral analgesic with/without antibiotics |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1 to 6 years
- Parent-reported ear pain in 24 hours prior to enrolment
- GP-diagnosis of (uni- or bilateral) AOM
Key exclusion criteria (8 listed)
- 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, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine hydrochloride 5mg/gAlso: Otalgan1-2 drops up to six times daily for a maximum of 7 days | Drug | Lidocaine ear drops with usual care |
Primary outcome
The Parent-reported Ear Pain Score Over the First Three Days
Time frame: 3 days
Parents will record their child's ear pain scores during the first three consecutive days using a 0-10 validated numerical rating scale. Higher scores indicate greater severity.
11 secondary outcomes
Proportion of Children Consuming Antibiotics
Time frame: in the first 7 days
Proportion of Children With Oral Analgesic Use
Time frame: in the first 7 days
Overall Symptom Burden (Crying/Distress, Disturbed Sleep, Interference With Normal Activity, Appetite, Fever and Hearing Problems) Using a 0-6 Likert Scale
Time frame: in the first 7 days
Number of Days With Ear Pain
Time frame: during follow up (4 weeks)
Number of GP Reconsultations With/Without Subsequent Antibiotic Prescribing
Time frame: during follow-up (4 weeks)
Number of Participants With Adverse Events
Time frame: during follow-up (4 weeks)
Number of Participants With Complications of AOM
Time frame: during follow-up (4 weeks)
Generic Quality of Life of the Child Assessed Using the 47-item Short-form of the Infant Toddler Quality of Life Questionnaire (ITQOL-SF47)
Time frame: At 4 weeks
Disease-specific Quality of Life of the Child Assessed Using the Otitis Media-6 (OM-6) Questionnaire
Time frame: At 4 weeks
Costs
Time frame: during follow-up (4 weeks)
Incremental Cost-effectiveness Ratios; Calculated by Dividing the Estimated Differences in Costs Between Groups by the Differences in Effects Observed
Time frame: during follow-up (4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36813504de Sevaux JLH, Damoiseaux RAMJ, Hullegie S, Sanders EAM, de Wit GA, Zuithoff NPA, Yardley L, Anthierens S, Little P, Hay AD, Schilder AGM, Venekamp RP. Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: study protocol of the OPTIMA pragmatic randomised controlled trial. BMJ Open. 2023 Feb 22;13(2):e062071. doi: 10.1136/bmjopen-2022-062071.
- Individual participant dataSharing planned: Yes. On completion of the trial, data will be stored for a minimum of 25 years at a central data drive at the Julius Center. The investigators will publish the metadata in the DataverseNL repository and will provide a persistent identifier. The data will be available to researchers who provide a methodologicaly sound proposal to achieve the aims in the approved proposal. Proposals to gain access to the data should be directed to the principle investigator (RPV). Data requestors will need to sign a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roderick Venekamp principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lidocaine hydrochloride 5mg/g in people with Acute Otitis Media and Pain, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Parent-reported Ear Pain Score Over the First Three Days (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05651633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.