Anti-shivering effect of intrathecal tramadol versus intravenous tramadol in patients Received spinal anesthesia for lower limb surgery. A randomized controlled clinical trial

Figures & data

Figure 1. Consort flow diagram

Table 1. Comparison between the two groups regarding patients’ characteristics (demographic data; age, sex, BMI and chronic illness).

Variables	Type of tramadol administration		p-value
	Intravenous tramadol (n = 43)	Intrathecal tramadol (n = 43)
Age (years), median(IQR)	46(21)	55(28)	0.10 ^a
Sex, n (%)
Male	24 (56.5)	26 (60.4)	0.66 ^b
Female	19 (43.5)	17 (39.6)
BMI (kg/m^2), median(IQR)	24.8(6.3)	27.7(6.9)	0.26 ^a
History of chronic illness n (%)
Absent	25 (58.1)	29 (67.5)	0.37^b
Present	18 (41.8)	14 (32.5)

Variables presented as Median and interquartile range (IQR) or patients’ number and percent as appropriate, ^a p-values are based on the Mann-Whitney U test. ^b p-values are based on the Chi-square test. Statistical significance at P < 0.05

Table 2. Intraoperative shivering (number of patients) in both groups.

Comparison between the two groups in regard to intraoperative shivering
Variables	Type of tramadol administration		p-value
	Intravenous tramadol (n = 43)	Intrathecal tramadol (n = 43)
Incidence of shivering	N (%)	N (%)
Absent	35 (81.4)	41 (95.4)	0.047 b*
Present	8 (18.6)	2 (4.6)
Shivering score	N (%) (n = 8)	N (%) (n = 2)
0 – None	0 (0)	0 (0)	0.88^a
1 – mild	2 (4.65)	1 (2.3)
2 – moderate	4 (9.3)	0 (0)
3 – severe	2 (4.65)	1 (2.3)

Variables are presented as patients’ number and percent,^ap-values are based on Fisher’s exact test. ^bp-values are based on chi-square test, *Statistical significance as P < 0.05

Table 3. Incidence of postoperative shivering.

Variables	Type of tramadol administration		p-value
	Intravenous tramadol (n = 43)	Intrathecal tramadol (n = 43)
Incidence of postop. shivering	N (%)	N (%)
Absent	34 (79)	40 (93)	0.045 a*
Present	9 (21)	3 (7)
Shivering score	N (%) (n = 9)	N (%) (n = 3)
0 – None	0 (0)	0 (0)	0.71^a
1 – mild	5 (11.66)	2 (4.66)
2 – moderate	3 (7)	1 (2.33)
3 – severe	1 (2.33)	0 (4.66)

Variables are presented as patients’ number and percent, p-values are based on Fisher’s exact test. *Statistical significance as P < 0.05

Table 4. Postoperative complications among the two groups.

Variables	Type of tramadol administration		p-value
	Intravenous tramadol (n = 43)	Intrathecal tramadol (n = 43)
Nausea
Present	12 (27.9)	4 (9.3)	0.026^b*
Absent	31 (72.1)	39 (90.7)
Vomiting
Present	4 (9.3)	2 (4.6)	0.39 ^b
Absent	39 (90.7)	41 (95.4)
Hypotension
Present	2 (4.6)	3 (7)	0.21 ^b
Absent	41 (95.4)	40 (93)

Variables are presented as patients’ number (percent), ^a p-values are based on Fisher exact test.

p-values are based on chi-square test, Statistical significance at P < 0.05