An Evaluation of Analgesic Efficacy and Clinical Acceptability of Intravenous Tramadol: RESULTS

In: Anesthesia

27 Oct 2009

Patients in the 2 groups were similar with respect to age, height, weight, gender distribution, and length of surgery (Table 1). There were no significant differences (P = .05) in age, weight, blood pressures (systolic, diastolic, mean arterial), pulse oximetry oxygen saturation, pegboard tests between the 2 groups at the various time intervals measured (Table 2). With regard to the perioperative sedation and anxiety levels at the different intervals, no significant differences were found between the 2 groups (P = .05). Analysis of the propofol administered revealed that almost equal amounts were given in both groups during surgery (tramadol group 206.8 mg ± 66.9; placebo group 206.0 ± 48.7). No or minimal technical difficulties were experienced by the surgeon in patients in either group. No nausea, vomiting, and dizziness were noted in either group, and similar recovery-room scores were obtained in both groups during the first 4 hours postoperatively. No significant (P < .05) *cardiovascular depression or fall in oxygen saturations were found in either group during the first 4 hours postoperatively. However, 3 patients self-reported nausea and vomiting after discharge, all being in the tramadol group. The 2 patients in the tramadol group that did not receive rescue analgesia reported no nausea or vomiting.

Table 1. Demographic Data

T/P

P/P

Number

22

23

Age (yrs)

29 ± 12

29 ± 13

Weight (kg)

68 ± 13

70 ± 13

Operating time (min)

42 ± 14

43 ± 12

Sex
Male

8

6

Female

14

17

Analysis of the pain scores showed significant differences between the 2 groups. The development of postoperative pain, as reflected by the VAS, is shown in Figures 1 and 2. The values displayed were derived from data recorded prior to the administration of rescue medication as well as from results obtained after the administration of the tramadol capsules. But in each patient that received rescue medication, all assessments recorded after the intake of the tramadol capsules were replaced by the last observation carried forward (LOCF). This approach can be seen in Figure 2.

Table 2. *Blood Pressure, Heart Rate, Respiratory Rate, Blood Oxygen Saturation Levels, and Pegboard Test*

Tramadol Propofol Placebo Propofol

Mean

SD

Mean

SD
Systolic pressure (mm Hg)
BD

132.0

16.7

127.3

15.4

BS

140.1

14.9

133.5

24.4

AS

130.3

14.4

131.0

18.1

Diastolic pressure (mm Hg)
BD

77.5

11.3

77.1

12.1

BS

80.9

8.8

77.8

15.8

AS

78.6

10.1

78.5

10.3

Mean pressure (mm Hg)
BD

97.6

15.8

93.4

13.3

BS

98.4

11.5

98.3

17.6

AS

93.3

9.9

95.3

14.1

Heart rate (beats/min)
BD

78.5

13.7

81.5

13.3

BS

75.6

12.1

79.6

10.1

AS

71.2

10.6

77.0

11.1

Respiratory rate (breaths/min)
BD

20.0

2.2

20.8

2.7

BS

19.4

2.2

19.3

2.2

AS

18.7

2.0

19.5

1.0

Oxygen saturation (%)
BD

98.5

1.0

98.4

1.1

BS

98.3

1.2

97.9

4.3

AS

97.9

1.7

96.6

8.2

Pegboard test
BD

36.8

5.3

39.1

5.7

BS

30.9

6.5

35.0

7.0

AS

35.0

4.6

35.9

7.6

When the continual-pain assessments and the carryover effects were tested for normality, it was found that these measurements were approximately normally distributed and therefore generalized linear models could be applied. Pain assessments were made at 1, 2, 3, 4, 6, 8, and 10 hours postoperatively. The 2 groups differed significantly at each individual time period (P = .0001). The average pain value of the tramadol group was significantly lower than that of the placebo group. Repeated measures using general linear models were also used to compare the LOCF effect between the 2 groups at the different time intervals. The 2 groups differed significantly at each individual time period (P = .0001). At each time period, the level of pain was lower in the tramadol group.
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Table 3. Area Under the Curve

Variable Statistic Tramadol/Propofol Placebo/Propofo I
Total pain Mean 15.91 ± 10.43 29.52 ± 14.64
Median 15 30
Range 33 53
Last observation carried forward (LOCF) Mean 21.29 ± 13.07 35.70 ± 19.00
Median 20 37
Range 48 56

The primary efficacy variable is the area under the curve (AUC) of the postoperative pain assessments as measured using the VAS. The smaller values indicate less overall pain. The AUCs were calculated in 2 different ways. In the first method, assessments made after a patient had taken postoperative analgesia were analyzed as if the analgesia had not been taken. In the second method, assessments made after a patient had taken postoperative analgesia were assumed to be missing and all missing assessments were substituted using LOCF. Using the first method, the mean AUC was 15.9 in the tramadol group as compared with 29.5 in the placebo group (P = .002). Using substitution for missing data (LOCF), the AUCs were 21.5 and 37.5 in the tramadol and placebo groups, respectively (P = .01). In Table 3, the AUCs are summarised by presenting the median and range for each treatment. altace blood pressure

Figure 1. Postoperative pain over time

Figure 1. Postoperative pain over time.

All patients in the placebo group received rescue analgesia, while 2 patients in the tramadol group did not receive rescue analgesia. Patients in the tramadol group also took significantly longer to take rescue analgesia (192.2 ± 52.6 min) than those in the placebo group (159.5 ± 48.1 min) (P = .02). The consumption of rescue analgesia was significantly lower at all time intervals measured in the tramadol group.
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Figure 2. Postoperative pain last observation carried forward

Figure 2. Postoperative pain last observation carried forward.

Patient movement causing difficulty in completing the surgery was significantly more in the placebo group (8 patients), whereas in the tramadol group, only 1 of the patients moved and made the procedure difficult to complete (P = .02). At follow-up the next day, clinical acceptability of the medications received were rated by 17 patients as “excellent” (VRS = 1) in the tramadol group, as compared with 9 patients in the placebo group (P = .02). In the tramadol group, only 1 patient rated their postoperative analgesia as “moderate to poor” (VRS = 3 and 4) as compared with 4 patients in the placebo group. crestor 10 mg

Figure 3. Escape analgesia

Figure 3. Escape analgesia.

The consumption of tramadol capsules from 3-10 hours is shown in Figure 3. The consumption of rescue analgesia was significantly lower at all time intervals measured in the tramadol group. Average capsule consumption in the tramadol group was 7.2 ± 2.2 as compared with 15.8 ± 4.9 in the placebo group (P = .01).td width=”89″ valign=”top”


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