Kheirandish‐Gozal 2016.
Methods | Parallel group RCT | |
Participants | 64 children, aged 2 to 10 years, with symptomatic snoring (AHI ≥ 2 hours total sleep time) | |
Interventions | Montelukast 4 mg or 5 mg (depending on the child's age) orally for 16 weeks; comparison against placebo for 16 weeks | |
Outcomes | AHI, respiratory arousal index, adenoid size | |
Notes | Enrolment period: January 2008 to December 2012 Funding sources: Investigator‐initiated grant from Merck Sharp and Dohme Corp. Declaration of interest: not provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "[...] using a table of random digits to generate the allocation sequence" |
Allocation concealment (selection bias) | Unclear risk | Unclear how allocation concealment was achieved. "A clinical research coordinator randomly assigned each child to either one of the two treatment groups by block randomisation (n=4/block)" "[...] the clinical pharmacy at the medical center handled delivery of medication to subjects per protocol randomisation." |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear who was blinded. "randomized, double‐blind controlled study" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "[...] of the seven children who withdrew from the study after enrolment, four were in the montelukast group and three children were in the placebo group." |
Selective reporting (reporting bias) | High risk | Trial registration specified need for adenotonsillectomy as primary outcome, but paper does not report on it. |
Other bias | Low risk | None. |
AHI: apnoea/hypopnoea index; OAHI: obstructive apnoea/hypopnoea index; OSA: obstructive sleep apnoea; PSG: polysomnography; RCT: randomised controlled trial; REM: rapid eye movement.