Summary of findings 2. Montelukast compared to placebo for obstructive sleep apnoea in children.
| Montelukast compared to placebo for obstructive sleep apnoea in children | ||||||
| Patient or population: obstructive sleep apnoea in children Setting: outpatients Intervention: montelukast Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with montelukast | |||||
| AHI (number of breathing pauses and episodes of shallow breathing per hour of sleep time) assessed with: polysomnography follow‐up: mean 14 weeks | The mean AHI was 7.55 per hour | MD 3.41 per hour lower (5.36 lower to 1.45 lower) | ‐ | 103 (2 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | |
| Desaturation index (number of times per hour of sleep time that the blood's O₂ level drops by a certain proportion from baseline) assessed with: polysomnography follow‐up: mean 14 weeks | The mean desaturation index was 5.16 per hour | MD 2.5 per hour lower (5.53 lower to 0.54 higher) | ‐ | 103 (2 RCTs) | ⊕⊕⊝⊝ LOW 2 3 | |
| Respiratory arousal index (number of times per hour of sleep time that an increased respiratory effort without a decrease in oxygen saturation is recorded) assessed with: polysomnography follow‐up: mean 14 weeks | The mean respiratory arousal index was 9.70 per hour | MD 2.89 per hour lower (4.68 lower to 1.10 lower) | ‐ | 103 (2 RCTs) | ⊕⊕⊕⊝ MODERATE 4 | |
| Nadir SpO₂ (lowest SpO₂ during sleep) assessed with: polysomnography follow‐up: mean 14 weeks | The mean nadir SpO₂ was 87.38% | MD 4.07% higher (2.27 higher to 5.88 higher) | ‐ | 103 (2 RCTs) | ⊕⊕⊕⊕ HIGH | |
| Serious adverse events (N experiencing event) | No serious adverse events reported. The following unintended effects were reported: headache (1), nausea (2) | No serious adverse events reported. The following unintended effects were reported: headache (1), nausea (1) | ||||
| *The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). AHI: Apnoea/hypopnoea index; CI: Confidence interval; SpO₂: oxygen saturation | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
1 Point estimates vary across studies, P = 0.10 for heterogeneity, I² = 54%. Downgraded once for inconsistency of results.
2 Point estimates vary greatly across studies, P = 0.004 for heterogeneity, I² = 88%. Downgraded once for inconsistency of results.
3 Upper boundary of 95% confidence interval suggests potential for negative effect of the treatment on the outcome. Downgraded once for imprecision.
4 Point estimates vary across studies, P = 0.12 for heterogeneity, I² = 59%. Downgraded once for imprecision.