Table 2.
Safety outcomes observed in children with malaria after administration of intramuscular or rectal quinine
Outcomes | Rectal group (n=450) | % (95% CI) | Intramuscular group (n=448) | % (95% CI) |
---|---|---|---|---|
Rectal side effects: | ||||
Presence of blood in stools* | 21 | 5 (3 to 7) | 3 | 1 (0 to 1) |
Blood in stools | 4 | 1 (0 to 2) | 0 | 0 |
Blood striation† | 17 | 4 (2 to 5) | 3 | 1 (0 to 1) |
At least one abnormal stool‡ | 357 | 79 (76 to 83) | 50 | 11 (8 to 14) |
Soft stools | 105 | 23 (19 to 27) | 24 | 5 (3 to 7) |
Liquid stools (<3 per day) | 105 | 23 (19 to 27) | 23 | 5 (3 to 7) |
Diarrhoea (≥3 stools per day)§ | 21 | 5 (3 to 6) | 5 | 1 (0 to 2) |
Mucoid stools | 296 | 66 (61 to 70) | 22 | 5 (3 to 7) |
Painful anal sphincter contraction and tenesmus | 46 | 10 (7 to 13) | 2 | 0.4 (0 to 1) |
Isolated painful anal sphincter contraction | 19 | 4 (2 to 6) | 1 | 0.2 (0 to 1) |
Isolated tenesmus | 10 | 2 (1 to 4) | 1 | 0.2 (0 to 1) |
Anal pruritus | 2 | 0.4 (0 to 1) | 1 | 0.2 (0 to 1) |
Intramuscular side effects: | ||||
Local inflammation of gluteus muscle | 0 | 355 | 79 (75 to 83) | |
Impaired mobility | 0 | 68 | 15 (12 to 18) | |
Decreased hip mobility | 0 | 9 | 2 (0 to 3) | |
Leg paraesthesia | 0 | 1 | 0.2 (0 to 1) | |
Pain during or after administration¶ | 9 | 2 (0 to 3) | 404 | 90 (87 to 92) |
Abscess | 1 | 0.2 (0 to 1) | 2 | 0.4 (0 to 1) |
Absolute difference 3.9% (95% confidence interval 2% to 6%), P<0.001.
Absolute difference 3.1% (1% to 5%), P=0.001.
Absolute difference 68.1% (62% to 75%), P<0.001.
Absolute difference 3.5% (1% to 6%), P=0.001.
Intramuscular v rectal: absolute difference 88.1% (85% to 91%), P<0.001.