Efficacy and safety of pre-emptive tapentadol on pain control in total knee arthroplasty: A randomized, double-blind, placebo-controlled trial

Table 1 Baseline characteristics of study participants

Parameters	Tapentadol (n = 44)	Placebo (n = 46)	P value
Mean age (mean ± SD)	61.07 ± 12.47	60.18 ± 11.18	0.75
Gender (male)	36%	22%	0.90
Mean body weight (mean ± SD)	63.50 ± 12.45	65.44 ± 11.40	0.46
Baseline visual analog scale score for osteoarthritis, median (IQR)	4 (4-5)	4 (4-5)	0.22
The duration between drug administration and surgery (minutes), median (IQR)	75.28 (62.70-78.03)	75.87 (60.25-78.88)	0.30
Duration of surgery(minutes), median (IQR)	68.20 (65.43-75.15)	69.04 (66.20-72.33)	0.16
Baseline cholecystokinin levels, median (IQR)	160.6 (138.39-206.58)	158.35 (120.45-197.48)	0.53

IQR: Interquartile range.

Table 2 Total pain reduction scales at different time points in both the groups, n (%)

Postoperative TOTPAR at different time points	TOTPAR (pain reduction)	Tapentadol (n = 44)	Placebo (n = 46)	Fisher’s exact (P value)
TOTPAR at 2 hours	Complete	40 (91)	25 (55)	0.020
	Mild	3 (5)	10 (26)
	Moderate	1 (2)	7 (18)
	None	0 (0)	4 (1)
TOTPAR at 4 hours	Complete	18 (43)	4 (4.5)	0.002
	Mild	6 (16)	16 (44)
	Moderate	16 (32)	23 (50)
	None	4 (8)	3 (1.5)
TOTPAR at 6 hours	Complete	3 (5)	3 (5)	0.006
	Mild	9 (24)	0 (0)
	Moderate	22 (51)	23 (52)
	None	7 (18)	16 (42)
TOTPAR at 12 hours	Complete	7 (15)	0 (0)	0.001
	Mild	17 (38)	20 (45)
	Moderate	15 (34)	2 (4)
	None	7 (15)	24 (52)
TOTPAR at 24 hours	Complete	14 (31)	0 (0)	0.001
	Mild	9 (20)	4 (9)
	Moderate	17 (38)	20 (45)
	None	5 (1)	22 (46)

TOTPAR: Total pain reduction.

Table 3 Analgesic consumption in 24 hours in both the groups

Parameters (mean ± SD)		Placebo (n = 38)	Tapentadol (n = 37)	P value
Total analgesic consumption		4.00 ± 0.86	3.10 ± 0.86	< 0.005
Individual analgesic consumption in 24 hours (mg)	Paracetamol	2000 ± 305.00	1850 ± 309.00	0.004
	Diclofenac	125 ± 35.96	72.24 ± 41.78	0.008
	Tramadol	76.67 ± 54.83	40.38 ± 51.77	0.001