6. Harms ‐ adverse events.
| Adverse event | Number of participants | Study | Glucocorticoid‐including group, N (%) | Placebo or comparator group, N (%) | Notes | |
| GLUCOCORTICOID versus PLACEBO, GLUCOCORTICOID versus EPINEPHRINE, GLUCOCORTICOID AND EPINEPHRINE versus PLACEBO | ||||||
| Gastrointestinal | Vomiting | 1466 | Plint 2009* | D + E: 2/199 (1) D + P: 5/199 (2.5) | P + E: 4/198 (2) P + P: 3/201 (1.5) | Observed in the emergency department by research nurse |
| Kuyucu 2004* | No events in either group (D + E, D + S, P + E, P + S) | Methods/timings NR | ||||
| Corneli 2007 | 16/305 (5.2) | 14/295 (4.7) | Within 20 minutes after administration of the study medication | |||
| Bleeding | 1576 | Corneli 2007 | No events in either group | # | ||
| Teeratakulpisarn 2007 | 2/90 (2) | 1/89 (1) | Occult blood; also assessed diarrhoea separately. Methods/timings NR | |||
| Plint 2009 | D + E: 17/199 (8.5) D + P: 12/199 (6) | P + E: 14/198 (7) P+P: 16/201 (8) | Dark stools; reported by families during the 22‐day telephone follow‐up. No patient had more than 1 episode | |||
| Endocrine | Hypertension | 1397 | Plint 2009 | D + E: 0/199 (0) D + P: 1/199 (0.5) | P + E: 1/198 (0.5) P + P: 0/201 (0) | Observed in infants admitted to hospital |
| Corneli 2007 | No events in either group | # | ||||
| Infectious | Pneumonia | 851 | Corneli 2007 | 1/305 (3.3) | 2/295 (7) | Also assessed empyema separately |
| Teeratakulpisarn 2007 | 0/90 (0) | 3/89 (3.4) | Methods/timings NR | |||
| Klassen 1997 | 1/35 (3) | 1/37 (3) | Methods/timings NR | |||
| Varicella | 1397 | Corneli 2007 | No events in either group | # | ||
| Plint 2009 | No events in either group | Reported by families during the 22‐day telephone follow‐up | ||||
| General | Tremor | 866 | Kuyucu 2004 | No events in either group | Methods/timings NR | |
| Plint 2009 | D + E: 4/199 (2) D + P: 5/199 (2.5) | P + E: 4/198 (2) P + P: 2/201 (1) | Observed in the emergency department by research nurse | |||
| Pallor/flushing | 866 | Kuyucu 2004 | No events in either group | Methods/timings NR | ||
| Plint 2009 | D + E: 23/199 (11.5) D + P: 15/199 (7.5) | P + E: 22/198 (11.1) P + P: 16/201 (8) | Observed in the emergency department by research nurse | |||
Additional reported adverse events: Goebel 2000 reported toxicity data: one patient was "jittery"; no evidence of further treatment complications. Plint 2009 also reported hyperkalaemia observed in infants admitted to hospital (only one case was noted in the dexamethasone group).
*epinephrine ‐ E; dexamethasone ‐ D; salbutamol ‐ S; placebo ‐ P
#Corneli 2007: Study clinicians and research assistants monitored the infants for adverse events during observation in the emergency department. Subsequent adverse events were determined at follow‐up. A patient safety committee, made up of people not involved with patient enrolment, tracked all adverse events.