Randomized, double-blind, placebo-controlled study to investigate the pharmacodynamic interaction of 5-HT3 antagonist ondansetron and paracetamol in postoperative patients operated  in an ENT department under local anesthesia

Uma A. Bhosale; Rahul Khobragade; Chetana Naik; Radha Yegnanarayan; Jyoti Kale

doi:10.1515/jbcpp-2014-0070

Article

Randomized, double-blind, placebo-controlled study to investigate the pharmacodynamic interaction of 5-HT₃ antagonist ondansetron and paracetamol in postoperative patients operated in an ENT department under local anesthesia

Uma A. Bhosale , Rahul Khobragade , Chetana Naik , Radha Yegnanarayan and Jyoti Kale

Published/Copyright: October 11, 2014

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From the journal Journal of Basic and Clinical Physiology and Pharmacology Volume 26 Issue 3

Abstract

Background: The preclinical incision pain models and clinical studies in healthy volunteers have demonstrated the central serotonergic analgesic mechanism, paracetamol analgesia. This has been evidenced by raised serotonin concentrations in the brain following paracetamol administration in a few studies. The inhibition of paracetamol analgesia by 5-HT₃ antagonists suggests that this analgesia is 5-HT₃ mediated. However, in a few studies, 5-HT₃ antagonists themselves exhibited an analgesic action. Various studies in this context stated intricate results. The present study was intended to understand the pharmacodynamic interaction between paracetamol and ondansetron in postoperative patients.

Methods: This randomized clinical trial included 32 postoperative cases of either sex, ages between 18 and 70 years. The patients were randomly allocated into the placebo and test groups and received respective treatment at the end of surgery. The pain score was recorded using Visual Analogue Scale (VAS) and Face, Legs, Activity, Cry, Consolability (FLACC) behavioral scale at awakening and every 30 min for the next 3 h. The postoperative rescue analgesic consumption for 24 h was recorded. The data were analyzed using OpenEpi and SciStatCalc statistical software.

Results: A significantly higher pain score was observed in the placebo group postoperatively for 60 min on VAS (p<0.05 and p<0.01), whereas the FLACC behavior scale score was significantly higher at 120 and 150 min (p<0.05). The test group patients were more comfortable throughout the study, and the postoperative analgesic requirement was significantly lesser (p<0.05).

Conclusions: The pharmacodynamic interaction between paracetamol and ondansetron coadministration does not block but instead increase paracetamol analgesia, reduce the postoperative analgesic requirement, and improve the postoperative comfort level.

Keywords: 5-HT3 antagonists; Face, Legs, Activity, Cry, Consolability (FLACC); pharmacodynamic interaction; Visual Analogue Scale (VAS)

Corresponding author: Dr. Uma A. Bhosale, Department of Pharmacology, Smt. Kashibai Navale Medical College and General Hospital, Narhe (Ambegaon), Pune-41, Maharashtra, India, E-mail: umabhosale2000@gmail.com

Acknowledgments

The authors thank Dr. A.V. Bhore, Dean of the Smt. Kashibai Navale Medical College, and Dr. R.W. Naphade, HOD Anesthesia, for providing the facilities to carry out the experiments of this work.

Conflict of interest statement

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission. Contribution details: Concepts: UAB; Design: UAB; Definition of intellectual content: UAB, RY; Literature search: UAB, RK; Clinical studies: UAB, RK, CN, JK; Data acquisition: RK, CN, JK; Data analysis: UAB, RK; Statistical analysis: UAB; Manuscript preparation: UAB; Manuscript editing: UAB; Manuscript review: UAB, RY; Guarantor: UAB.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2014-6-23

Accepted: 2014-8-7

Published Online: 2014-10-11

Published in Print: 2015-5-1

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Articles in the same Issue

https://doi.org/10.1515/jbcpp-2014-0070

Keywords for this article

5-HT3 antagonists; Face, Legs, Activity, Cry, Consolability (FLACC); pharmacodynamic interaction; Visual Analogue Scale (VAS)