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Table 7 Adverse events in the study

From: Oral prednisolone for acute otitis media in children: a pilot, pragmatic, randomised, open-label, controlled study (OPAL study)

Adverse events

Prednisolone group (n = 31)

Control (n = 31)

No ptsa

Day 1–3

Day 4–7

Day 8–14

No ptsa

Day 1–3

Day 4–7

Day 8–14

Increased appetite

18

11

15

17

17

9

10

7

Increased urine volume

11

8

9

7

14

12

7

4

Weight gain

13

5

6

6

11

4

4

10

Gastritis

2

3

2

0

4

2

0

0

Nausea

6

4

1

0

7

5

4

1

Vomiting

5

3

0

0

3

3

1

1

Diarrhoea

2

3

1

1

4

1

0

0

Drowsiness

23

14

9

6

13

16

10

5

Anxiety

4

3

3

3

6

3

1

1

Headache

4

1

0

1

6

7

2

3

Skin rash

3

0

1

0

0

2

0

0

Candidiasis

3

2

1

0

1

1

0

0

Dry mouth

7

5

4

0

6

6

3

1

Sleep disturbance

17

5

5

3

10

9

1

0

Others

1

0b

1

0

0

0

0

0

Serious adverse effects

0

0

0

0

0

0

0

0

  1. aTotal number of patients having the adverse event during the first 2 weeks
  2. bPatient was detected to have anemia at day 6 (no baseline Hb count was identified) at the primary care centre and was referred to paediatrician
  3. Pts patients