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. |
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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. |