Background: Shivering occurs during both general anesthesia and regional anesthesia, but it is more frequent and troublesome during regional anesthesia. Objective: To evaluate the efficacy and safety of tramadol in comparison to pethidine for control post- spinal shivering in women undergoing cesarean section at Khartoum Maternity Hospital. Methodology: It was an interventional prospective, double-blind clinical trial and hospital based study implemented during a time period of six month from (January to July 2013) in Khartoum Maternity Hospital. A total of 100 grade I & II pregnant ladies who scheduled for elective caesarean section under spinal anesthesia and subsequently developed shivering were included. The patients were randomly divided into 2 groups. Group A; 50 patients who received 0.50 mg/kg tramadol intravenously. Group B; 50 patients who received 0.5 mg/kg pethidine intravenously. Results: The incidence and severity of shivering, at 5, 15 and 30 minutes postoperatively was reduced significantly in Case Group A (tram dole). Five (10%) patients in the tramadol group and 19 (38.0%) patients in the pethidine group developed significant side effects (P = 0.02) Conclusion: Tramadol when used to control post- spinal shivering was shown to be effective, more potent, with less rates of recurrence and with less observed side effects than pecidine in decreasing post- spinal shivering.
PAround 40-60% of patients under regional anesthesia develop shivering. Post anesthetic shivering (PAS) is the existence of involuntary, randomized, spontaneous movements in skeletal muscles; giving rise to discomfort and unpleasant feeling. It is known to be a frequent complication, reported in 40-70% of patients at recovery. Shivering results in a 200-500 % increase in oxygen consumption index along with raised CO2 production, ventilation and cardiac output. Many pharmacological interventions are used to decrease the incidence and to reduce the severity of post anesthetic shivering, including clonidine, ketamine, doxapram, tramadol, and pethidine. Among these agents, pethidine and tramadol have been widely used, in the treatment of PAS. Non pharmacological methods which use specialized equipments to prevent or to control shivering are expensive and are not practical in all clinical settings. Talakoub et al, moreover, reported both tramadol and meperidine to be effective in treating post- spinal shivering in women undergoing cesarean section. The present paper focus to evaluate the safety and efficacy of pethidine and tramadol for control of post- spinal shivering in women undergoing cesarean section.
and Methods It was an interventional prospective, double-blind clinical trial and hospital based study implemented during a time period of six month from (January to July 2013) in Khartoum Maternity Hospital. A total of 100 ASA grade I and II pregnant ladies, age between 15-45 years underwent caesarean section under spinal anesthesia that subsequently developed shivering were included. They were randomly divided into one of the two groups. Group A; 50 patients were receiving 0.50 mg/kg Tramadol intravenous. Group B; 50 patients were receiving 0.5 mg/kg Pethidine intravenous. All the women in physical status, ASA class I and II, who did not have any contraindication for receiving the specified drugs. Table 1 outlines the classification of the severity of post anesthetic shivering. The drug was administered by other anesthetic personnel who is blinded to whether the drug contains pethidine or tramadol. The same person assessed the effect of the drug administration based on the format provided. All the patients were assessed for shivering grades, its disappearance, hemodynamic status, and complications if any. Patients were observed at intervals of 1 min till 5 minutes, and thereafter at 15,20, 30 and 45minutes. Baseline Pulse rate, B.P, SPO2, Respiratory rate, and temperature was noted, and also during shivering, and thereafter the drug administration at regular intervals. Recurrence of shivering was also noted and an additional dose of either Tramadol or Pethidine in a dose of 0.25 mg/kg iv was given in respective groups.
Table 1. Grading system for severity score of post anesthetic shivering
Statistical analysis was performed via SPSS software (SPSS, Chicago, IL, USA). Continuous variables were compared using student’s t test (for paired data) or Mann–Whitney U test for non-parametric data. For categorical data, comparison was done using Chi-square test (X2) or Fisher’s Exact test when appropriate. A P value of <0.05 was considered statistically significant. Ethical clearance and approval for conducting this research was obtained from the general manager of the hospital and informed written consent was obtained from every respondent who agreed to participate in the study.
The mean age of patients in the study group was 32.93 ±5.26 years; while that in the control group was 31.35±2.22 years. The difference was not statistically significant. The mean duration of surgery was 45±0.23 minutes in the case group A and 50±0.36 minutes in control group B. The difference was not statistically significant. The mean BMI of women in the study group was 20.93±2.51; while that in the control group was 21.53±1.37. The difference was not statistically significant.
Table 2. Shows the nonparametric correlation between case and control regarding overall demographic data.
The mean duration of shivering was 24±0.41 minutes in the Case Group A and 27±0.46 minutes in Control Group B. The difference was statistically significant. Recurrence of shivering present in both groups, but in the pethidine group recurrence was seen as early as 30 minutes 24% whereas it was 12% at 45 minutes with Tramadol (Table. 2). The difference was statistically significant.
Table 3. Shows the nonparametric correlation between case and control regarding severity of postoperative shivering.
Table 3 showed shivering -free incidence after drugs administration. After 5 minutes; the difference was statistically significant between 46 (92%) patients in case group A and 27 (54%) in control group B. After 15 minutes; the difference was statistically significant between 50 (100%) patients in case group A, and 42 (84%) in control group B. After 30 minutes; the difference was statistically significant between 50 (100%) patients in case group A, and 44 (88%) in control group B. Five (10%) patients in the tramadol group and 19 (38.0%) patients in the pethidine group developed significant side effects (P = 0.02) The mean time at which shivering stopped was 4.52±.76 minutes in tramadol group, while that in the control group was8.46±.82minutes. The difference was statistically significant.
Regional anesthesia is emerging as safe and popular technique both in elective and emergency situations in the modern anesthesia practice. Incidence of post anesthesia shivering is high . PAS is influenced by the type of anesthetic agent used . Volatile agents like halothane are associated with a high incidence of shivering when compared with opioid and nitrous oxide based anesthesia . Many studies have demonstrated the usefulness of Tramadol in control of shivering; studies have also demonstrated that, Tramodol is more effective in treatment of shivering when compared to other drugs like Pethidine and amytriptyline [17,18]. The results of the present study showed a decrease in the incidence and severity of shivering observed in women emerging from spinal anesthesia post caesarean section after receiving tramadol, which was free (92%.100% and 100%) after 5, 15 and 30 minutes in tramadol group compare to (54% 84% and 88%) to pethidine group respectively. There was statistically significant difference between the times of stop shivering in study group when compared to control group. Also our study revealed low incidence of side effects noted in tramadol group compare to pethidine group. Talakoub et al studied the effect Tramdol 0.5 mg/kg and Pethidine 0.5 mg/kg on post anesthetic shivering in parturient under spinal anesthesia. In their study, time of cessation of shivering from the time of drug administration was 2.5 minutes for Tramadol and 5.0 minutes for pethidine. The time taken for cessation of shivering in the present study is comparable though slightly higher than the above study .
Moreover, the present study confirms the findings of studies by Bhatnagar et al, in their study administered Tramadol at 1mg/ kg and pethidine at 0.5 mg/kg iv for post anesthetic shivering. They found that the number of patients who stopped shivering in 10 minutes were significantly higher in Tramadol group when compared to pethidine group . In another studies, Dhimar  and Seifi SA , proving that application of tramadol significantly reduces the incidence of postoperative shivering. Additionally the current study matches previous data from findings of studies performed by Tsai et al showed tramadol to be an effective drug in the treatment of shivering following epidural anesthesia in pregnant women because of its low affinity for opium receptors and modulatory effects on central monoaminergic tracts . Additionally, our data correlate with Saha et al, who reported that tramadol significantly reduces the incidence and severity of shivering following open and laparoscopic cholecystectomy operation . Heid et al, similarly, reported that intraoperative administration of tramadol is an effective medication in lowering the incidence and extent of postoperative shivering without influencing the pain perception in lumbar disc surgery . In the present study it was found that Tramadol controlled PAS faster than pethidine with less recurrence. Similar data has been reported by other studies [9,15]. Also recurrence of shivering present in both groups, but in the pethidine group recurrence was seen as early as 30 minutes whereas it was 45 mins with Tramadol. Since Tramadol does not cause significant respiratory depression, it can be safely used in management of recurrence of shivering. The probable reason for recurrence of shivering could be result of low concentration of the active drug, when hypothermia is still persisting and individual variations in the core temperature.
Tramdol when was used for control post- spinal shivering, was shown to be effective , more potent ,with less rates of recurrence and with less observed side effects than pethidine in decreasing postoperative caesarean section shivering.
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