Related Experiment Video
Updated: Nov 2, 2025
Assessment of the Efficacy of An Osteopathic Treatment in Infants with Biomechanical Impairments to Suckling
Published on: February 5, 2019
Comparing Watchful Waiting Approach vs. Antibiotic Therapy in Children with Nonsevere Acute Otitis Media: A
Leila Shahbaznejad1, Ensieh Talaei1, Fatemeh Hosseinzadeh1
1Pediatric Infectious Diseases Research Center, Communicable Diseases Institute, Mazandaran University of Medical Sciences, Sari, Iran.
Insights
Antibiotic treatment for acute otitis media (AOM) in children led to faster recovery than watchful waiting. However, antibiotic use increased diarrhea risk, with no significant difference in AOM recurrence or middle ear effusion after one month.
Area of Science:
- Pediatrics
- Infectious Diseases
- Clinical Pharmacology
Background:
- Acute otitis media (AOM) is a common childhood infection.
- Treatment approaches for nonsevere AOM include antibiotics and watchful waiting.
- Evidence comparing these strategies in Iran is limited.
Purpose of the Study:
- To compare the efficacy and safety of amoxicillin treatment versus watchful waiting for nonsevere AOM in Iranian children.
- To evaluate AOM recovery rates, recurrence, and adverse drug reactions.
Main Methods:
- Randomized clinical trial involving 396 children aged 6 months to 6 years with AOM.
- Intervention group received amoxicillin (80 mg/kg/day for 7-10 days).
- Control group underwent a watchful waiting approach. Outcomes assessed at 72 hours, 1 month, and 3 months.
Main Results:
- Significantly higher AOM recovery at 72 hours in the amoxicillin group (73%) compared to watchful waiting (44%).
- No significant difference in AOM recurrence or middle ear effusion persistence at 1 month.
- Higher AOM recurrence between 1-3 months in the control group; increased diarrhea in the intervention group.
Conclusions:
- Antibiotic treatment accelerates AOM recovery but carries a risk of side effects like diarrhea.
- Watchful waiting may be a viable option for nonsevere AOM, but requires careful monitoring for recurrence.
Objective:
To compare both approaches for the treatment of nonsevere acute otitis media (AOM) in Iran.
Methods:
This randomized clinical trial was performed at a pediatric infectious diseases clinic in Buali tertiary hospital in Sari, north of Iran, from 2016 to 2018. All participants in this study were previously healthy children with AOM diagnosis, who were 6 months to 6 years old. The patients were randomly assigned into two groups: the intervention (80 mg/kg/day amoxicillin for 7-10 days) and the control group (watchful waiting approach). AOM recovery and adverse drug reactions were evaluated after 72 hours, and the patients were followed for the frequency of AOM and middle ear effusion 1 and 3 months' postintervention.
Results:
A total of 396 children have participated in this study. AOM recovery was significantly different in the two groups (73% vs. 44% in the intervention and control groups, respectively). Recurrence of AOM and middle ear effusion (MEE) persistence, one month following the intervention, have not shown any significant differences between the two groups. However, the AOM recurrence between 1 and 3 months was more frequent in the control group. The frequency of diarrhea was also higher in the intervention group compared to the control but no significant difference was found between the two groups regarding vomiting and skin rash.
Conclusion:
The faster recovery from AOM is achieved when an antibiotic treatment regimen is applied, although the risk of potential side effects should be considered.
Related Concept Videos
01:26Tonsillitis II: Management
00:57Antibiotic Selection
01:28Antimicrobial Effectiveness
01:28Acute Pyelonephritis II: Diagnostic Studies and Management
01:22Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
01:26Pharmacokinetics in Pediatric Patients: Drug Excretion