Main Article Content

Abstract

Background : Gender difference exists both in pharmacokinetics and pharmacodynamics of various drugs. So this study was designed to evaluate efficacy and safety of Tramadol in males versus female patients suffering from pain.


Material and Methods : An open randomized parallel group study was conducted . 100 patients enrolled were 50 males and 50 females coming to Department of Orthopedics, in a tertiary care hospital.  All patients were divided into four groups of 25 each. Tramadol was prescribed in two doses of 50mg or 100mg BD for 7 to 14 days depending on severity (based on Visual Analogue Scale) and then patients were monitored and adverse drug reactions were noted in males and females. The data was analyzed statistically using T- test for efficacy and descriptive stats for assessing the safety.


Results : Efficacy was assessed by comparing difference in mean score and mean percentage change in mean score. Comparing males and females taking 50 mg tramadol percentage improvement was not statistically significant (p > 0.05). While comparing 50 mg and 100 mg percentage improvement in groups was statistically significant (p <0.05). Comparing groups males and females, percentage of adverse drug reaction in females was higher on each dose of tramadol. Percentage of adverse drug reaction in group taking 100mg was higher compared to group taking 50mg tramadol.


Conclusion: There was no significant difference in efficacy of tramadol between males and females on same dose. Females experience more adverse drug reactions than males on same dose of tramadol and ADR increases with increase in dose.

Keywords

Tramadol gender difference VAS severe pain

Article Details

How to Cite
Kiranpreet Kaur, Harinder Singh, Hardeep Singh Mann, Anjleen Kaur, & Prabhsimran Singh. (2021). A comparative study of efficacy and safety of tramadol in male versus female patients suffering from pain. International Journal of Research in Pharmacology & Pharmacotherapeutics, 4(1), 106-112. https://doi.org/10.61096/ijrpp.v4.iss1.2015.106-112

References

  1. [1] Gureje O, Simon GE, Von Korff M. A cross-national study of the course of persistent pain in primary care. Pain. 2001;92(1-2):195-200.
  2. [2] Raffa RB, Friderichs E, Reimann W, Shank RP, Codd EE, Vaught JL. Opioid and nonopioid components independently contribute to the mechanism of action of tramadol, an 'atypical' opioid analgesic. J Pharmacol Exp Ther 1992;260(1):275-85.
  3. [3] Preston KL, Jasinski DR, Testa M. Abuse potential and pharmacological comparison of tramadol and morphine. Drug and Alcohol Dependence. 1991;27(1):7–17.
  4. [4] Rademaker M. Do women have more adverse drug reactions? Am J Clin Dermatol. 2001;2(6):349-51.
  5. [5] Pinto N, Dolan ME. Clinically relevant genetic variations in drug metabolizing enzymes. Curr Drug Metab 2011;12(5):487-97.
  6. [6] Gear RW, Gordon NC, Heller PH, Paul S, Miaskowski C, Levine JD. Gender difference in analgesic response to the kappa-opioid pentazocine. Neurosci Lett. 1996;205(3):207-9.
  7. [7] Hui-Chen L, Yang Y, Na W, Ming D, Jian-Fang L, Hong-Yuan X. Pharmacokinetic of enantiomers of Trans- Tramadol and its active metabolite, Trans-O-desmethyl Tramadol, in healthy male and female Chinese volunteers. Chirality 2004;(2):112-8.
  8. [8] Spilker B. Drug development and approval process. In : Speight TM, Holford NHG, Editors. Avery's Drug Treatment. (4th edn.) Auckland Adis International; 1997:423-49. 11.10.
  9. [9] Beaulieu AD, Peloso P, Bensen W, Clark AJ, Watson CP, Gardner-Nix J et al. A randomized double- blind, 8- week crossover study of once-daily controlled-release tramadol versus immediate-release tramadol taken as needed for chronic noncancer pain. Clin Ther. 2007;29(1):49-60.
  10. [10] Mahajan BK, Methods in Biostatics for Medical Students and Research Workers (7th ed). New Delhi; Jaypee; 2010.
  11. [11] McQuay H. Opioids in Pain Management. In: Lancet 1999;353 (9171):2229-32.
  12. [12] Maher TJ, Chaiyakul P. Opioids (Bench). In: Smith HS, editor. Drugs for pain. Philadelphia: Hanley and Belfus; 2003;83-96.
  13. [13] Russell J, Kamin M, Bennett RM, Schnitzer TJ, Green JA, Katz WA. Efficacy of tramadol in treatment of pain in fibromyalgia. JCR: Journal of Clinical Rheumatology. 2000;6(5):250–257.
  14. [14] Prakash S, Tyagi R, Gogia AR,Singh R, Prakash S, Efficacy of three doses of Tramadol with bupivacaine for caudal analgesia in Paediatric inguinal herniotomy. Br J Anaesth. 2006;97(3):385-8.
  15. [15] Mongin G, Yakusevich V, Köpe A, Shostak N, Pikhlak E, Popdán L et al. Efficacy and Safety Assessment of a Novel Once-Daily Tablet Formulation of Tramadol : A Randomised, Controlled Study versus Twice-Daily Tramadol in Patients with Osteoarthritis of the Knee. Clin Drug Investig. 2004;24(9):545-58.
  16. [16] Harris RZ, Benet LZ, Schwartz JB. Gender effects in pharmacokinetics and pharmacodynamics. Drugs. 1995;50(2):222-39.
  17. [17] Zhou SF. Polymorphism of human cytochrome P450 2D6 and its clinical significance: Part I. Clin Pharmacokinet Naunyn Schmiedebergs Arch Pharmacol 2009;48(11):689-723.
  18. [18] Liu HC, Jin SM, Wang YL. Gender-related differences in pharmacokinetics of enantiomers of trans-tramadol and its active metabolite, trans-O-demethyltramadol, in rats. Acta Pharmacol Sinn 2003;24(12):1265-9.