Splinter 1997.
| Methods | Prospective, randomized, single‐blind study | |
| Participants | N = 333, ASA I‐II, age 1.5 to 15 years | |
| Interventions | Early removal ‐ The LMA was removed before return of airway reflexes. Late removal ‐ The LMA was removed after patient had awakened and had intact airway reflexes, exhibiting purposeful movements including swallowing as an indication of protective reflexes |
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| Outcomes | Laryngospasm Desaturation (< 90%) Postop nausea or vomiting Stridor Breath holding Excessive salivation |
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| Notes | Induction ‐ N2O + O2+ halothane/propofol Maintenance ‐ N2O + halothane, isoflurane in older children |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomly assigned via a computer generated random numbers table" |
| Allocation concealment (selection bias) | Unclear risk | COMMENT ‐ No mention of method of allocation concealment |
| Blinding (performance bias and detection bias) Of outcome assessor to all outcomes | Unclear risk | "single blinding" COMMENT ‐ It is not clear if the outcome assessor was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | COMMENT ‐ 333 patients were enrolled but 25 did not undergo intervention (the LMA was not used in 17 and surgery was cancelled in 8). However, the results are reported in 310 patients (no response to correspondence seeking clarification on this discrepancy) |
| Selective reporting (reporting bias) | Low risk | COMMENT ‐ Though no explicit statement, the outcomes mentioned in methodology have been reported |