Outcomes | Paracetamol (n=52) | Ibuprofen (n=52) | Paracetamol plus ibuprofen (n=52) |
---|---|---|---|

Primary outcomes | |||

Mean (SD) time without fever in first 4 hours (minutes)* | 116.2 (65.0) | 156.0 (57.6) | 171.1 (40.8) |

No discomfort at 48 hours† | 34 (65) | 37 (71) | 36 (69) |

Secondary outcomes: | |||

Outcomes at 24 hours: | |||

Mean (SD) time until first fever clearance (minutes)‡ | 71.0 (69.1) | 42.2 (33.5) | 45.5 (34.3) |

Mean (SD) time without fever in first 24 hours (minutes)* | 940.3 (362.9) | 1055.2 (329.7) | 1217.4 (237.6) |

No discomfort† | 22 (44) | 36 (69) | 29 (56) |

Normal activity† | 20 (40) | 20 (58) | 23 (48) |

Normal appetite† | 10 (21) | 14 (27) | 14 (29) |

Normal sleep† | 17 (37) | 13 (50) | 20 (37) |

Outcomes at 48 hours: | |||

Mean (SD) temperature (°C)§ | 36.4 (0.89) | 36.4 (0.85) | 36.6 (1.01) |

Normal activity† | 31 (60) | 37 (73) | 28 (54) |

Normal appetite† | 21 (41) | 22 (44) | 21(41) |

Normal sleep† | 27 (52) | 31 (61) | 25 (48) |

Outcomes at day 5: | |||

Mean (SD) temperature (°C)** | 36.2 (0.93) | 36.1 (0.78) | 36.0 (0.66) |

No discomfort† | 43 (88) | 38 (81) | 38 (76) |

Normal activity† | 44 (90) | 39 (85) | 37 (73) |

Normal appetite† | 29 (58) | 29 (59) | 32 (62) |

Normal sleep† | 31 (62) | 25 (50) | 27 (53) |

*Time spent with temperature less than 37.2°C in first four hours after first dose of drug, using number of valid 30 second interval points from data logger; unknown for zero, one, and two children in three groups, respectively, by four hours, and zero, two, and two, respectively, by 24 hours. Time without fever over first four hours was 48 minutes for paracetamol, 65 minutes for ibuprofen, and 71 minutes for paracetamol plus ibuprofen and for time without fever in first 24 hours was 65 minutes for paracetamol, 73 minutes for ibuprofen, and 84 minutes for paracetamol plus ibuprofen.

†Children reported at relevant time to be “normal” (see table 1); denominators may vary owing to missing data (in most cases fewer than four children).

‡Time from baseline until temperature first falls below 37.2°C; unknown for five children (zero, two, and three, respectively) and right censored at 240 minutes for three children.

§Measured by research nurse; unknown for one, five, and two children, respectively.

**Measured by parent; unknown for four, seven, and three children, respectively.