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. 2020 Jan 17;2020(1):CD007074. doi: 10.1002/14651858.CD007074.pub3

Goldbart 2012.

Methods Parallel group RCT
Participants 46 children, age 2 to 10 years, with snoring and mild to moderate OSA (AHI 1 to 8 per hour)
Interventions Montelukast 4 mg or 5 mg (depending on the child's age) orally for 12 weeks; comparison against placebo for 12 weeks
Outcomes AHI, adenoidal/nasopharyngeal ratio; measured after 12 weeks
Notes Enrolment period: not stated
Funding sources: Dr. Asher Tal received research support and the study medication from MSD Israel.
Declaration of interest: Dr. Asher Tal participated in speaking engagements for MSD, Teva, and Sanofi‐Aventis.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "We chose block randomisation (blocks of 4, by using a table of random digits) to create the allocation sequence."
Allocation concealment (selection bias) Low risk "The numbers on the containers (medication and placebo) were drawn by the chief pharmacist (according to the numbers in the randomisation table)."
Blinding (performance bias and detection bias) 
 All outcomes Low risk "During the study, the investigators were blinded to group assignment. Montelukast and placebo tablets were provided in identical, similarly colored, opaque capsules."
"[Sleep] studies were initially scored by a certified technician. The scores were then blindly reviewed by 2 physicians experienced in paediatric polysomnography."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised participants finished the study.
Selective reporting (reporting bias) Low risk No study protocol or trial registration were available, but outcomes appeared to be complete.
Other bias Unclear risk The investigators performed an interim analysis after 30 children (Goldbart 2012) were enrolled; it is unclear how the analysis and results affected blinding, trial continuation, and outcome selection.