A COMPARISON OF EQUIPOTENT DOSES OF TRAMADOL AND NALBUPHINE IN GYNECOLOGICAL LAPAROTOMIES POSTOPERATIVELY.
Objective: To compare the mean consumption of equipotent doses of tramadol and nalbuphine for first 12 hours of post-operative analgesia, in patients undergoing gynaecological laparotomies.
Study Design: Randomized clinical trial.
Place and Durration of Study: Hameed Latif Hospital Lahore from 6 months.
Materials and Methods: One hundred American society of anaesthesiologists (ASA) I and II, consenting females, ages between 20 and 50 years were divided randomly into two equal groups. All patients were given a loading dose of either tramadol (1.5mg/kg) or nalbuphine (0.15mg/kg) after the induction of anesthesia. Same drug was continued as baseline infusion; tramadol 0.5mg/kg or nalbuphine 0.05mg/kg respectively was given as a bolus whenever the visual analogue scale (VAS) score was [greater than or equal to]3. Total dose given in bolus was calculated and compared. Time at the instant of first demand of analgesia in postop was also noted in both groups.
Results: Mean SD dose of rescue boluses in Tramadol group was 89.26 +- 40.00 mg, while mean of equipotent dose of Nalbuphine group was 134.72 +- 61.81 mg (p<0.001). The difference between groups was statistically significant.
Conclusion: Requirement for equipotent doses of analgesic were less in case of tramadol as compared to nalbuphin for treatment of breakthrough pain when both drugs were given as bolus at the commencement of surgery and continued as a continuous infusion postoperatively.
Keywords: Postoperative analgesia, nalbuphine, tramadol, VAS score.
Non availability of u-receptor opioids forces the anesthetists working in some parts of the world to use substitutes like nalbuphine; which is a k-receptor agonist and antagonist at u-opioid1; or tramadol, which acts as a weak u agonist with additional alpha-2 agonist activity and weak inhibitor of norepinephrine and serotonin reuptake2. Tramadol has demonstrated rapid recovery and low incidence of side effects in early postoperative period when given intravenously3. It has been advocated as an alternative to intravenous morphine for postoperative pain relief4. Analgesia with tramadol has been compared with morphine when given through the epidural and intra-articular route with less adverse effects5,6. ED50 values (95% confidence interval) of tramadol was 627 +- 69 mg7. In another study, the cumulative dose of nalbuphine was compared with morphine and found to be 32 +- 10 mg for nalbuphine and 30 +- 9 mg for morphine8.
Our literature search did yield a direct comparison of tramadol and nalbuphine for acute postoperative pain. Considering nalbuphine to be ten times more potent than tramadol9, we undertook this study to compare the amount of tramadol or nalbuphine required to maintain a visual analogue scale (VAS) score at a level 3). The patients in group N received 0.15mg/ kilogram intravenous nalbuphine, infusion at the rate of 0.02 mg/kilogram/hour for 12 hours; 0.05mg/kilogram nalbuphin was given for break through pain.
All patients received a loading dose of study drug at the time of induction of anesthesia; continuous infusion of the drug at a constant rate was then commenced and continued in post anaesthesia care unit. Additional boluses of the same drug were given in post-anesthesia care unit (PACU) to treat breakthrough pain; they were repeated till VAS score returned to <3. These dosages were calculated assuming nalbuphine to be ten times more potent than tramadol. Additional doses were repeated until a VAS score <3 was achieved or effects of study drugs like excessive sedation (Ramsay 3 or more) or respiratory depression (Respiratory rate <8 or SpO2 3.
All data were entered in SPSS version 17 and analyzed. Normality was tested by Shapiro Wilks test and the data for quantitative variables like amount of doses were computed as mean +- SD along median (IQR). Amount of doses (mean consumption) and mean time for first requirement were compared by using Mann Whitney U-test. Chi-square test wast used to compare ASA status and surgery type between groups. P-value [?]0.05 was considered to be significant.
Out of 100 patients in both the groups no patient was excluded from the study. Both the groups were statistically comparable regarding the distribution of age sub-categorized into 20-29, 30-39, 40-49 and 50-59 (Chi2=6.075; p=0.108; mean +- SD 36.20 +- 8.555 vs 32.72 +- 8.112), weight (t=-0.356; p=0.722; Mean +- SD 68.18 +- 7.33 vs 68.72 +- 7.80 ), ASA status (Chi2=0.164; p=0.685 ) table-I, and types of surgical procedures (Chi2=6.690; p=0.082 ) table-II.
The difference between the amount of drugs consumed by continuous infusion after the procedure was not significant (Mann Whitney U=1179, p=0.622) table-III. Amount of nalbuphine consumed as on demand boluses was significantly >equipotent amount of tramadol (Mann Whitney U=700, p3 over a first 12 hours was significantly higher than tramadol. According to our knowledge this is the first direct comparison of these drugs for postoperative analgesia in gynaecological laparotomies.
Hernandez-Palacios et al conducted a similar study in children while comparing postoperative pain relief in children. Their study showed that a bolus dose of tramadol (1,000 ug/kg) followed by an infusion rate of 2.0 ug/kg/min resulted in better control of postoperative pain than a bolus dose of nalbuphine (100 ug/kg) followed by an infusion of nalbuphine (0.2 ug/kg/min)10.
Mean VAS scores at first demand of analgesia in both groups remained > 4.0 (4.94 +- 0.91 vs 5.66 +-1.239; p=0.001) both patients in both groups required additional boluses of study drugs. The groups also showed a significant difference in time to first demand of analgesia (0.057 +- 0.48 vs 1.06 +- 1.46 hours; p=0.027).
Our study has shown that in comparison with nalbuphine, intravenous tramadol required fewer number of rescue boluses and consumed less amount of drug to achieve satisfactory analgesia during first 12 hours postoperatively. This has logistic implications as every rescue bolus is a demand on nursing care. Whether this also has an impact on side effects like nausea, vomiting, sedation and respiratory depression was not observed in this study. Hopefully, our study will pave way for more studies to follow.
CONFLICT OF INTEREST
This study has no conflict of interest to declare by any author.
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7. Nassaman VE, ramadhayani U, Kadowtz,PJ, Nossaman BD. Advances in perioperative pain managemet: use of medications with dual analgesic mechanisms, Tramadol and Tapentadol. Anesthesiology Clin 2010; 28; 647-66.
8. Minai FN, Khan FA. A comparison of morphine and nalbuphine for intraoperative and postoperative analgesia. J Pak Med Assoc. 2003; 53(9): 391-6.
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|Publication:||Pakistan Armed Forces Medical Journal|
|Article Type:||Clinical report|
|Date:||Oct 31, 2016|
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