Table 3.

Drug-related adverse effects.

	SDE (n = 38)	Placebo (n = 40)	P value
Pyrexia (>37ºC)	0	0	–
Dizziness
0–24 h	23 (60.5)	14 (35.0)	.040
At 48 h	19 (50.0)	5 (12.5)	.0005
At 72 h	15 (39.5)	2 (5.0)	.0002
At 7 d	3 (7.9)	0	.111
Nausea (±vomiting)
0–24 h	18 (47.4)	15 (37.5)	.492
At 48 h	9 (23.7)	2 (5.0)	.023
At 72 h	5 (13.1)	0	.024
At 7 d	0	0	–
Injection site soreness*
0–24 h	4 (10.5)	3 (7.5)	.708
At 48 h	10 (26.3)	4 (10.0)	.079
At 72 h	18 (47.4)	5 (12.5)	.001
At 7 d	13 (34.2)	1 (2.5)	.0002
Injection site reactions†
0–24 h	0	0	–
At 48 h	4 (10.5)	1 (2.5)	.195
At 72 h	9 (23.7)	1 (2.5)	.006
At 7 d	8 (21.0)	2 (5.0)	.045

Data were analyzed using the Fisher exact test and are presented as n (%). Dizziness was defined as feeling faint, weak or/and unsteady gait.^[19] Nausea was defined as feeling of retching or stomach distress with an urge to vomit.^[19]

SDE = sebacoyl dinalbuphine ester.

^*Tenderness or painful sensation on the injection site of SDE or placebo solution.

^†Reactions including erythematous change and focal swelling.