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Effect of montelukast on acute otitis media in children

Clinical trial to compare the efficacy of amoxicillin and amoxicillin combined with montelukast for treatment of acute otitis media in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016040627236N2
Enrollment
100
Registered
2016-08-21
Start date
2015-12-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute otitis media. Acute suppurative otitis media

Interventions

Intervention 1: Intervention group 1: amoxicillin 80-90 mg/Kg daily for 10 days. Intervention 2: Intervention group 2: montelukast at a dose of 5 mg daily and amoxicillin 80-90 mg/Kg daily for 10 days
Treatment - Drugs
Intervention group 1: amoxicillin 80-90 mg/Kg daily for 10 days
Intervention group 2: montelukast at a dose of 5 mg daily and amoxicillin 80-90 mg/Kg daily for 10 days

Sponsors

Vice chancellor for research of Hormozgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Children 2-6 years; Diagnosis of acute otitis media Exclusion criteria: Receiving prophylactic steroids or montelukast; Chronic lung or heart disease or immune deficiency (Primary, Secondary); Long medication for any reason; Sensitivity to montelukast; Lack of parents cooperation; Need to change antibiotics during the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Recovery of symptoms: pain, redness and bulging of eardrum. Timepoint: Days 2-4 and 10-14 of the intervention. Method of measurement: Statements of the patient (parents) and pneumatic otoscope.

Secondary

MeasureTime frame
Middle ear effusion. Timepoint: Post intervention. Method of measurement: Pneumatic otoscope.;Ruptured eardrum. Timepoint: Post intervention. Method of measurement: Pneumatic otoscope.;Recurrence. Timepoint: Post intervention. Method of measurement: Pneumatic otoscope.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Fatemeh Sabouri

Children Hospital

saboori_fatemeh@yahoo.com+98 76 3366 6240

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026