Varshini Talari*, Rachana Esarapu1, Gowthami Kannuri1, Sharan Kotari1
Corresponding Author: Varshini Talari, Mallareddy College of Pharmacy, Affiliated to Osmania University, India.
Copy Right: © 2020 Varshini Talari, This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Received Date: August 08, 2020
Published Date: September 01, 2020
Abstract
Background & Objectives
Control of post operative shivering is essential as shivering is a cause of discomfort and dissatisfaction in patients undergoing operations under anaesthesia.
The aim of the study is to assess the efficacy and safety of intravenous Clonidine, Butorphanol and Tramadol in the treatment of post operative shivering.
Primary objectives
To assess the effectiveness of tramadol, butorphanol and clonidine in patients with post operative shivering.
To assess the incidence of Adverse Drug reactions associated with Therapy using NARANJO ADVERSE REACTION PROBABILITY SCALE.
To compare safety and efficacy of tramadol, butorphanol and clonidine in patients with post operative shivering.
Secondary objectives
To monitor the patients for recurrence of shivering upon cessation of drugs.
Methodology
This is a prospective study which was conducted for 6months in the department of anaesthesia. The patients were divided into three groups of 30 each - Group A (n=30) receiving Tramadol 50 mg/kg IV, Group-B (n=30) who received Butorphanol 20mg IV and Group- C (n=30) comprised of the patients who received Clonidine 150mcg intravenously. The efficacy and response rate of the study drugs were evaluated and recorded. Side effects like, nausea, vomiting, hypotension, sedation were recorded. All data were analyzed using One – Way Anova.
Results
A total number of 90 patients were included in the study (N= 90). The study population was categorized into three groups based on drug administration.
A marked decrease in the systolic Blood Pressure and Heart Rate with clonidine was observed (p<0.05). Tramadol receiving patients reported incidence of nausea and vomiting where as butorphanol is associated with sedation.
Conclusion
Complete control of post operative shivering with less or no severe side effects was achieved with Butorphanol in comparisons to clonidine and Tramadol.
Keywords
Shivering, Tramadol, Clonidine, Butorphanol, Post operative shivering.
Introduction
Regional anaesthesia is widely used as a safe technique for both elective and emergency operations. Shivering is known to be a frequent complication, reported in 40 to 70 % of patients undergoing surgery. Shivering is usually defined as readily detectable tremor or fasciculation of face, neck, jaw, head, trunk or extremities lasting longer than 15 seconds. Shivering is very unpleasant, physiologically stressful for the patient undergoing surgery and some patients find the accompanying cold sensation to be worse than surgical pain. Shivering is associated with many hazardous effects like it increases metabolic rate which may lead to increase in oxygen consumption by 100-600% with increased carbon dioxide production. It can cause arterial hypoxemia, raised intracranial and intraocular pressure. It can lead to adverse post operative outcomes like increased wound pain and infection which leads to delayed discharge of the patient. [1]
Anaesthesia impairs the thermo-regulation by inhibiting vasomotor and shivering responses and by redistribution of heat from core to periphery of the body resulting in hypothermia during spinal anaesthesia. Shivering is considered to be a physiological response to core temperature in an attempt to raise the metabolic heat production. It increases oxygen demand, heart rate, cardiac output, lactic acidosis, increased intra ocular pressure, increased intra cranial pressure, increased carbon dioxide production, hemodynamic changes and increased pain perception. Thus it may cause distress to patients especially to those with low cardio pulmonary reserve. To prevent and treat this complication, warming of the patients with warm IV infusion, increasing the operation room temperature is undertaken. Apart from this various therapeutic agents are used, which include Meperidine, Clonidine, Dexmedetomidine, Nefopam, Anticholinergics, Opiate agonist (Tramadol etc). Dexamethasone, however every aforesaid agent has its own adverse effects and the most ideal anti-shivering agent is still not found. [2] Αlpha-2 receptor agonists like Clonidine and Dexmedetomidine are another important class of anti shivering agents that, unlike meperidine, causes little respiratory depression. Tramadol is an opioid analgesic with opioid action possibly mediated through mu-receptor with minimal effect on kappa and delta binding sites. Tramadol also activates the mononergic receptor of the descending neuraxial inhibiting pain pathway. The anti-shivering action of tramadol is probably mediated via its opioid or serotonergic and noradrenergic activity or both. Butorphanol, an easily available opioid, is commonly used as an IV analgesic agent but there are very few studies demonstrating its use for control of shivering. Hence it becomes essential to find an appropriate drug for post operative shivering that is safe, effective and quick in action.
Materials and Methods
After obtaining approval from the ethical committee and written informed consent, patients of either sex aged 18 to 60 years scheduled for Patients posted for procedures under anaesthesia were included in study at the department of Anaesthesia of MALLA REDDY HOSPITAL, Suraram, Rang Reddy district, Telangana for a period of six months. Patients who were not willing to participate. Patients with known hypersensitivity to tramadol, butorphanol and clonidine, known history of alcohol or substance abuse. Patients with Fever, Hypo or Hyperthyroidism, Morbid Obesity, Drug Allergy, Severe Diabetes, Urological Diseases were excluded. Categorization of 90 patients in to three groups Group A: Tramadol -50mg (n = 30); Group B: Butorphanol-20mg (n =30); Group C: Clonidine 150mcg (n = 30). Patients were assessed for the improvement in therapy and the time taken from drug administration till the cessation of shivering was accurately noted. Temperature, heart rate, oxygen saturation and blood pressure were monitored at intervals of 10 minutes till the cessation of shivering. Patients were closely monitored for failure of the drug response, recurrence of shivering & adverse effects. Assessment of level of Shivering using Bedside Shivering Assessment Scale.
Grade 0: No shivering
Grade 1: Shivering in face and head – MILD
Grade 2: Shivering in face and upper extremities – MODERATE
Grade 3: Shivering in face and lower extremities – SEVERE
Grade 4: Shivering with whole body
Results
A total of 90 patients were included in the study (N=90). Out of which 75 were given spinal 15 were given general anaesthesia.The study population was categorized into three groups based on drug administration.
Discussion
Anaesthesia carries two dreaded side effects, one is hypotension and another is shivering. Ironically every anaesthesiologist and allied persons are well prepared to deal with the hypotension and every pre and Para operative arrangement and precautions are taken to counter it because it may become life threatening, whereas shivering is least taken care off unless it appears, though it happens in 40-70% of cases, and is very agonizing to the patient. Various pharmaceutical agents are being used to treat it though the most effective with least ADR’s is not yet determined. The patients were divided into three groups based on the drug administration. The drugs administered here are Group-A (n=30) receiving tramadol 50 mg IV, Group-B (n=30) who received butorphanol 20mg IV and Group-C (n=30) comprised of the patients who received Clonidine 150mcg intravenously.
Clonidine is a centrally acting selective α2 agonist and apart from being well known for its sedative effects, it is an established anti shivering agent. Tramadol is an opioid analgesic with opioid action preferably mediated through ‘μ’ receptors with minimal effect on kappa and delta binding sites. Tramadol also activates the mononergic receptors of the descending neuraxial pain inhibiting pathway. The mechanism of anti-shivering actions of Tramadol is not fully understood as yet though it is probably mediated through its opioid or serotonergic and noradrenergic activity or both. Butorphanol, an easily available opioid, acts through k and μ receptor agonistic modulation.
The study population showed more number of patients in the age group of 18 – 25 years with female predominance and this is because lower segment C- section was the highest performed surgery in this study site.
Tramadol was given at a dose of 50mg in this study which was in accordance with the study conducted by Mohta et al[28] which showed three doses of Tramadol, i.e., 1mg, 2mg and 3mg per kg were effective for prophylaxis of shivering. Time taken to control shivering is fast in Group – B when compared with tramadol and clonidine which is similar to the study conducted by Dr. Niranjan Kumar Verma et al.[23] Recurrence of shivering was seen in Group – A and Group – B which is in accordance with the study conducted by Dr. Niranjan Kumar Verma et al.[23] The patients in Group – C did not show any recurrence which is in contrast to the study conducted by Sheikh Mustak Ali et al.[21] Axillary Temperature and Oxygen Saturation did not show much variance on administration of the drugs which is in contrast to the study conducted by Astha Palan et al.[19] A marked decrease in the systolic blood pressure and heart rate with clonidine was observed which is similar to Dr. Niranjan Kumar Verma et al.[23] Both tramadol and butorphanol did not have much affect on hemodynamic parameters of the patients which is similar to the study conducted by Maheshwari et al.[26]
Patients on tramadol reported very severe nausea and vomiting that require further management and this was in accordance with the study conducted by Mohta et al.[28] Butorphanol is associated with sedation which is similar to the study conducted by Joshi et al.[20]
Conclusion
The study drugs tramadol, butorphanol and clonidine are effective to control shivering. Tramadol is better when compared to clonidine due to lesser sedation and no hypotensive effect, but nausea and vomiting are more common and severe with tramadol. Though clonidine is effective in controlling shivering, it causes a prominent reduction in blood pressure and heart rate which makes its use difficult in all the age groups and also for the patients with cardiovascular co-morbidities. Butorphanol is better when compared to tramadol and clonidine in treating shivering because of its higher success rate and fewer side effects. Butorphanol was found to be safe and effective in prevention and treatment of post operative shivering with no hemodynamic, cardio respiratory side effect in comparison to Clonidine and Tramadol.
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