Trial Outcomes & Findings for Analgesic Ear Drops for Children With Acute Otitis Media (NCT NCT05651633)
NCT ID: NCT05651633
Last Updated: 2026-07-16
Results Overview
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.
TERMINATED
PHASE3
29 participants
3 days
2026-07-16
Participant Flow
Participant milestones
| Measure |
Lidocaine Ear Drops With Usual Care
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Lidocaine Ear Drops With Usual Care
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lidocaine Ear Drops With Usual Care
n=15 Participants
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 Participants
Usual care: oral analgesic with/without antibiotics
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.3 years
STANDARD_DEVIATION 1.4 • n=15 Participants
|
2.9 years
STANDARD_DEVIATION 1.5 • n=14 Participants
|
2.6 years
STANDARD_DEVIATION 1.5 • n=29 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=15 Participants
|
6 Participants
n=14 Participants
|
11 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=15 Participants
|
8 Participants
n=14 Participants
|
18 Participants
n=29 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Baseline ear pain score (0-10)
|
7.7 units on a 0-10 rating scale
STANDARD_DEVIATION 1.6 • n=15 Participants
|
6.5 units on a 0-10 rating scale
STANDARD_DEVIATION 1.9 • n=14 Participants
|
7.1 units on a 0-10 rating scale
STANDARD_DEVIATION 1.8 • n=29 Participants
|
|
Number of days in pain
|
2.8 Days
STANDARD_DEVIATION 1.5 • n=15 Participants
|
2.9 Days
STANDARD_DEVIATION 1.9 • n=14 Participants
|
2.9 Days
STANDARD_DEVIATION 1.7 • n=29 Participants
|
|
Baseline antibiotic prescription
|
5 Participants
n=15 Participants
|
3 Participants
n=14 Participants
|
8 Participants
n=29 Participants
|
|
Bilateral AOM
|
5 Participants
n=15 Participants
|
4 Participants
n=14 Participants
|
9 Participants
n=29 Participants
|
|
Household smoking
|
3 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
3 Participants
n=29 Participants
|
|
Additional children in household
|
9 Participants
n=15 Participants
|
10 Participants
n=14 Participants
|
19 Participants
n=29 Participants
|
|
Breastfed at 3 months
|
10 Participants
n=15 Participants
|
10 Participants
n=14 Participants
|
20 Participants
n=29 Participants
|
|
Body temperature
|
37.7 Degrees Celcius
STANDARD_DEVIATION 0.99 • n=15 Participants
|
38.2 Degrees Celcius
STANDARD_DEVIATION 1.07 • n=14 Participants
|
37.9 Degrees Celcius
STANDARD_DEVIATION 1.04 • n=29 Participants
|
PRIMARY outcome
Timeframe: 3 daysParents 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.
Outcome measures
| Measure |
Lidocaine Ear Drops With Usual Care
n=14 Participants
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 Participants
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
The Parent-reported Ear Pain Score Over the First Three Days
|
4.4868 Score on a 0-10 rating scale
Interval 3.077 to 5.8966
|
4.3465 Score on a 0-10 rating scale
Interval 2.9367 to 5.7564
|
SECONDARY outcome
Timeframe: in the first 7 daysproportion of children consuming antibiotics during first 7 days
Outcome measures
| Measure |
Lidocaine Ear Drops With Usual Care
n=14 Participants
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 Participants
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Proportion of Children Consuming Antibiotics
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: in the first 7 daysproportion of children with oral analgesic use during first 7 days
Outcome measures
| Measure |
Lidocaine Ear Drops With Usual Care
n=14 Participants
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 Participants
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Proportion of Children With Oral Analgesic Use
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: in the first 7 daysPopulation: Outcome data not collected since collection of these data were, on hindsight, considered not sufficiently relevant to outweigh the burden associated with collecting and calculation of these data.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during follow up (4 weeks)Number of days with pain score of 1 or greater on a scale of 0-10, where higher scores indicate greater pain".
Outcome measures
| Measure |
Lidocaine Ear Drops With Usual Care
n=13 Participants
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=13 Participants
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Number of Days With Ear Pain
|
6.5 Days
Standard Deviation 5.78
|
4.6 Days
Standard Deviation 3.29
|
SECONDARY outcome
Timeframe: during follow-up (4 weeks)Outcome measures
| Measure |
Lidocaine Ear Drops With Usual Care
n=14 Participants
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 Participants
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Number of GP Reconsultations With/Without Subsequent Antibiotic Prescribing
|
7 Number of GP repeat consultations
|
18 Number of GP repeat consultations
|
SECONDARY outcome
Timeframe: during follow-up (4 weeks)Population: Data for one participant from the intervention group missing for the diarrhoea/vomiting adverse event.
Proportion of participants experiencing adverse events during follow-up
Outcome measures
| Measure |
Lidocaine Ear Drops With Usual Care
n=14 Participants
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 Participants
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Number of Participants With Adverse Events
Local discomfort during administration
|
10 Participants
|
—
|
|
Number of Participants With Adverse Events
Difficulties during administration
|
7 Participants
|
—
|
|
Number of Participants With Adverse Events
Diarrhoea/Vomiting
|
2 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
Rash in/around ear
|
1 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
Pruritis
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: during follow-up (4 weeks)Outcome measures
| Measure |
Lidocaine Ear Drops With Usual Care
n=14 Participants
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 Participants
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Number of Participants With Complications of AOM
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 4 weeksThe 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)
Outcome measures
| Measure |
Lidocaine Ear Drops With Usual Care
n=14 Participants
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 Participants
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Generic Quality of Life of the Child Assessed Using the 47-item Short-form of the Infant Toddler Quality of Life Questionnaire (ITQOL-SF47)
Physical abilities at 4 weeks
|
87.1 Units on a scale (0-100)
Standard Deviation 13.31
|
86.6 Units on a scale (0-100)
Standard Deviation 15.07
|
|
Generic Quality of Life of the Child Assessed Using the 47-item Short-form of the Infant Toddler Quality of Life Questionnaire (ITQOL-SF47)
General health perceptions at 4 weeks
|
66.3 Units on a scale (0-100)
Standard Deviation 14.7
|
69.03 Units on a scale (0-100)
Standard Deviation 21.09
|
|
Generic Quality of Life of the Child Assessed Using the 47-item Short-form of the Infant Toddler Quality of Life Questionnaire (ITQOL-SF47)
Parental emotional impact at 4 weeks
|
86.9 Units on a scale (0-100)
Standard Deviation 12.95
|
88.5 Units on a scale (0-100)
Standard Deviation 9.91
|
SECONDARY outcome
Timeframe: At 4 weeksThe 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.
Outcome measures
| Measure |
Lidocaine Ear Drops With Usual Care
n=14 Participants
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 Participants
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Disease-specific Quality of Life of the Child Assessed Using the Otitis Media-6 (OM-6) Questionnaire
|
22.1 Units on a scale
Standard Deviation 5.26
|
18.7 Units on a scale
Standard Deviation 6.47
|
SECONDARY outcome
Timeframe: during follow-up (4 weeks)Population: Outcome data not collected since collection of these data were, on hindsight, considered not sufficiently relevant to outweigh the burden associated with collecting and calculation of these data.
Mean costs per patient will be compared across the randomisation groups
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: during follow-up (4 weeks)Population: Cost outcome data not collected since collection of these data were, on hindsight, considered not sufficiently relevant to outweigh the burden associated with collecting and calculation of these data.
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
Outcome measures
Outcome data not reported
Adverse Events
Lidocaine Ear Drops With Usual Care
Usual Care
Serious adverse events
| Measure |
Lidocaine Ear Drops With Usual Care
n=14 participants at risk
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 participants at risk
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalisation
|
7.1%
1/14 • Number of events 1 • 28 days of follow-up
|
0.00%
0/14 • 28 days of follow-up
|
Other adverse events
| Measure |
Lidocaine Ear Drops With Usual Care
n=14 participants at risk
usual care: oral analgesic with/without antibiotics
lidocaine hydrochloride 5mg/g: 1-2 drops up to six times daily for a maximum of 7 days
|
Usual Care
n=14 participants at risk
Usual care: oral analgesic with/without antibiotics
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.1%
1/14 • Number of events 1 • 28 days of follow-up
|
0.00%
0/14 • 28 days of follow-up
|
|
Gastrointestinal disorders
Diarrhoea/Vomiting
|
14.3%
2/14 • Number of events 2 • 28 days of follow-up
|
28.6%
4/14 • Number of events 4 • 28 days of follow-up
|
|
Skin and subcutaneous tissue disorders
Rash in/around ear
|
7.1%
1/14 • Number of events 1 • 28 days of follow-up
|
28.6%
4/14 • Number of events 4 • 28 days of follow-up
|
Additional Information
Dr. Roderick P. Venekamp
Department of General Practice & Nursing Science, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place