Table 2.
Main outcome measures in children with recurrent acute otitis media randomised to receive adenoidectomy, sulfafurazole prophylaxis, or placebo
|
Adenoidectomy
|
Sulfafurazole
|
Placebo
|
||||||
|---|---|---|---|---|---|---|---|---|
| Time | No* | No (%) of failures† | Difference‡(95% CI) | No* | No (%) of failures† | Difference‡(95% CI) | No* | No (%) of failures† |
|
Analysis where protocol violations were regarded as drop outs
| ||||||||
| At 6 months | 59/60 | 25 (42) | 10 (−9 to 29) | 46/60 | 17 (34) | 18 (−2 to 38) | 47/60 | 26 (52) |
| At 24 months | 58/60 | 42 (76) | 0 (−17 to 17) | 41/60 | 27 (60) | 15 (−4 to 35) | 45/60 | 35 (76) |
|
Analysis where protocol violations were regarded as failures
| ||||||||
| At 6 months | 60/60 | 26 (43) | 15 (−3 to 33) | 56/60 | 27 (47) | 12 (−7 to 30) | 53/60 | 32 (58) |
| At 24 months | 59/60 | 43 (76) | 3 (−13 to 19) | 53/60 | 39 (71) | 7 (−9 to 24) | 51/60 | 41 (79) |
*
Effective sample size (total minus drop outs)/total sample size.
†
Defined as having two episodes of acute otitis media in two months or three in six months or middle ear effusion for two months.
‡
Compared with placebo.