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Table of Content - Volume 17 Issue 1 - January 2021
Comparison of analgesic efficacy of caudal dexmedetomidine versus caudal tramadol with bupivacaine 0.25% in Pediatric infra-umbilical surgeries
Mitali B Saraswala1*, Ajay G Prajapati2
1,2Consultant Anaesthesiologist, Department of Anaesthesiology Sudeep Group of Hospitals, City Light Road, Surat, Gujarat, INDIA. Email: saraswala_mitali@yahoo.com
Abstract Background: Regional anesthesia is safe and effective in pediatric patients. It provides postoperative analgesia and reduces requirements of inhalational and intravenous agents with minimum sedation. Caudal epidural block is one of the most popular, reliable and safe techniques in paediatric analgesia that can be used with general anesthesia for intra and postoperative analgesia in patients undergoing infraumbilical surgeries. Material and Methods: The aim of this study is to compare the analgesic efficacy of caudal dexmedetomidine versus caudal tramadol with bupivacaine 0.25 % in pediatric Infra-umbilical surgeries. Patients with age group of 1-8 years, ASA grade II, and I coming for infra-umbilical surgeries are included in the study. Study included total 60 patients. Patients has been divided in two groups. 1) Group A: Patients receiving bupivacaine 0.25% 1 ml/kg with tramadol in a dose of 1 mg/kg.2) Group B: Patients receiving bupivacaine 0.25% 1 ml/kg with dexmedetomidine in a dose of 1 ug/kg. Thirty patients has been enrolled in each group. Result: There was no significant difference in pulse rate intra-operative and post-operative up to 24 hours(p˃0.05). There was no significant difference in MBP intra-operative and post-operative up to 24 hours. (p˃ 0.05). Sedation score was 2.0±0.4 up to 1 hr post-operatively in Group BT patients. So, after 1 hr of surgery, patients of BT group remained anxious, restless and agitated. While in-group BD, Sedation score was 2.0±0.3 up to 6 hrs. post-operatively. Thus all patients remained co-operative, oriented and tranquil up to 6hr post-operatively. Conclusion: Caudal Dexmedetomidine 1 µg/kg with 0.25% bupivacaine 1 ml/kg provided significant post-operative pain relief up to 13.2±2.8 hrs. with prolonged duration of arousable sedation. Comparable, while using caudal tramadol 1 mg/kg with 0.25% bupivacaine also provided significant post-operative pain relief up to 6.9±1.2 hrs. but less duration than Dexmedetomidine. Key Words: caudal anesthesia, tramadol, bupivacaine, dexmedetomidine.
INTRODUCTION Pain is defined by the international association for study of pain as “An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”.1 The society of Pediatric anesthesia, on its 15thannual meeting at New Orleans, Louisiana (2001) clearly defined alleviation of pain as a “basic human right”, irrespective of age, medical condition, treatment, primary service response for the patient care or medical institution. In past pain has been underestimated in children and many times they received inadequate analgesia. Later pain pathways have been identified in children and therefore postoperative analgesia in children is also gaining importance.2 Regional anesthesia is safe and effective in pediatric patients. It provides postoperative analgesia and reduces requirements of inhalational and intravenous agents with minimum sedation.3 Caudal epidural block is one of the most popular, reliable and safe techniques in pediatric analgesia that can be used with general anesthesia for intra and postoperative analgesia in patients undergoing infraumbilical surgeries. The block can be practiced by a single shot injection or as a continue infusion, use of a caudal catheter is usually not preferred due to high risk of catheter contamination from fecal soiling. Caudal analgesia could reduce the requirement of inhaled anesthetics and opioids, attenuate the stress response to surgery, facilitate a rapid, smooth recovery, and provide good immediate postoperative analgesia.4 The main disadvantage of caudal analgesia is the short duration of action after a single injection even with the use of long acting local anesthetic like bupivacaine. Prolongation of caudal analgesia using a single shot technique has been achieved by the addition of various adjuvants, such as opioids, ketamine, and neostigmine and α2 agonists. Caudal opioids have advantages of prolonging the duration of analgesia over bupivacaine alone, but have side effects such as nausea, vomiting, pruritus and late respiratory depression, which can be minimized by reducing concentration.5 Bupivacaine, is a long-acting amide local anesthetic that has provided reliable anesthesia and analgesia with differential motor-sensory blockade. It acts by inhibiting sodium channels in the nerve membrane. 0.25% bupivacaine produces adequate motor and sensory blockade in lower abdominal surgery. but it has some disadvantages like short and finite duration of anesthesia and larger doses require for analgesics in the postoperative period. This can be avoided by using higher doses of bupivacaine which again can produce cardiac toxicity, duration of analgesia due to bupivacaine in caudal anesthesia can be increased by using adjuvants.5,6,7 Dexmedetomidine, a stereoisomer of medetomidine, is a highly selective α2-adrenergic receptor agonist with eight times more specificity for α2 adrenoceptors than clonidine (ratios of α2:α1 activity, 1620:1 for dexmedetomidine and 220:1 for clonidine). It provides better perioperative hemodynamic stability than many other adjuvants now in use and good quality of intraoperative and prolonged post-operative analgesia with minimal side effects. It has sympatholytic, analgesic and sedative effects and is remarkably free from side effects except for manageable hypotension and bradycardia.8 Tramadol, A synthetic analogue of codeine, is a racemic mixture of two enantiomers, both of which contributes to the analgesic activity through different mechanism enhancing inhibitory effect on pain transmission in the spinal cord. Tramadol interacts with μ, δ and κ receptors where it exhibits purely agonist. It has moderate affinity for μ receptor and weak affinity for δ and κ receptors. Tramadol is approximately one-tenth as potent an analgesic as morphine with lack of respiratory depressant effect. Tramadol interacts the re-uptake of noradrenaline and serotonin. These neurotransmitters elevate the pain threshold there by producing inhibition of pain.9,10 Considering the above facts, the present study was designed to compare caudal analgesia of 0.25% Bupivacaine 1 ml/kg with tramadol 1 mg/kg and 0.25% Bupivacaine 1 ml/kg with dexmedetomidine 1 µg/kg for duration of post-operative analgesia, hemodynamic stability, post-operative sedation and any adverse effects in children undergoing infra-umbilical surgeries. The aim of this study is to compare the analgesic efficacy of caudal dexmedetomidine versus caudal tramadol with bupivacaine 0.25% in pediatric Infra-umbilical surgeries. Objectives: To study hemodynamic changes in both study groups, To study the duration of post-operative analgesia in both the groups, To compare motor block and post - operative sedation, To study the side effect associated with analgesia in both the groups.
MATERIAL AND METHODS The present study was carried out as prospective observational study. After approval from institutional Ethical committees, written informed consent from all the patients’ caretaker before surgery was observed. Patient’s inclusion and exclusion criteria Patient Selection: Age group of 1-8 years, ASA grade II, and I Patients coming for infra-umbilical surgeries. Exclusion criteria: ASA grade III and IV, infected wounds at sacrum, coagulopathy or anticoagulation, congenital sacral anomalies, meningitis, patients’ history of allergy to local anesthetics, immunocompromised patients, Patients who are not willing to participate in study. Method: After enrollment, patient's detailed history was elicited including medical history and history of drug allergy. Though general examination has been carried out including general condition of patient, vitals (temperature, pulse, B.P.), pallor, edema and icterus. Systemic examination including detailed respiratory and CVS examination was done. After all preoperative assessment, premedication was given to the patient. The caudal block was given to each patient following standard method.
RESULT Table 1: Socio-clinical characteristics distribution of study participants (N=60)
* - Chi-square Test, ** - Student ‘t’ Test. value expressed as mean ± SD
Table 2: Pulse distribution of study participants (N=60)
** - Student ‘t’ Test
Table 3: Mean blood pressure (MBP) distribution of study participants (N=60)
** - Student ‘t’ Test
Table 4: Ramsay Sedation Scale distribution of study participants (N=60)
** - Student ‘t’ Test
Table 5: FLACC Score distribution of study participants (N=60)
** - Student ‘t’ Test
Table 8: Duration of analgesia among study participants (N=60)
* - Chi-square Test, ** - Student ‘t’ Test
DISCUSSION Treatment of acute pain is one of the most important tasks of perioperative paediatric anaesthesia. Pain relieving agents are usually administered on the basis of the concept of balanced analgesia, which involves a combination of analgesics with either synergistic or additive effects. It allows rapid recovery from anaesthesia with effective postoperative analgesia. Caudal epidural blockade is one of the most popular regional block used in paediatric anaesthesia. This reliable and safe technique is used widely for many surgical procedures in combination with general anaesthesia. It allows rapid recovery from anaesthesia with effective post-operative analgesia.It reduces the stress hormone levels produced during anaesthesia. It reduces the intraoperative and postoperative analgesic requirements in the form of narcotics and NSAIDs. It also helps in early ambulation and less hospital stay, thereby alleviating most of the anxiety and burden of the child’s parents. Local anaesthetics alone, especially Bupivacaine, were commonly used in the past in caudal technique for providing pain relief. Bupivacaine has some disadvantages like short duration of regional anesthesia and larger doses require for analgesics in the postoperative period. This resulted in the usage of various adjuvants to the local anaesthetics to prolong their analgesic effect postoperatively, like morphine, tramadol, adrenaline, ketamine, neostigmine, clonidine, dexmedetomidine. Bupivacaine is a long-acting amide local anaesthetic that has provided reliable anaesthesia and analgesia with differential motor-sensory blockade for more than 40 years. Tramadol also is one of the most commonly used adjuvants with local anesthetic in caudal block. Studies have established the safety of tramadol as caudal adjuvant without significant adverse effects. (doda,solanki nm, stoelting rk,vicker md)]. Shrestha S.K. et al.9, Nasreen laiq10 and Senel AC et al.16 used tramadol (1mg/kg) with 0.25% bupivacaine (1 ml/kg) for infraumbilical surgeries. They concluded addition of tramadol prolongs the duration of analgesia without producing significant adverse effects. Dexmedetomidine is the most recent alpha‐2 agonist agent approved by FDA IN 1999 for use in humans for analgesia and sedation. It provides better perioperative haemodynamic stability than many other adjuvants now in use and good quality of intraoperative and prolonged post-operative analgesia with minimal side effects. Dexmedetomidine enhances the effects of local anaesthetics without increasing the incidence of side effects(ishii.h,ib-achache ). One of the major advantages of dexmedetomidine over other sedatives is its respiratory effects, which are minimal in adults and children (afonso j). Dexmedetomidine provides an interesting quality of sedation that permits arousal with gentle stimulation. (Petroz,el-hennawy, Anand) Goyal V, Kubre J and Radhakrishnan K, used dexmedetomidine (1ug/kg) with 0.25% bupivacaine (1 ml/kg) for infraumbilical surgeries . They concluded addition of dexmedetomidine prolongs the duration of analgesia without producing significant adverse effects. there was no incidence of respiratory depression in both of group. No patient in either group had a decrease or increase in HR and MAP to 30% of basal value. so no need of any therapeutic intervention in our study. In present study, there was no statistically significant difference in mean heart rate, mean arterial pressure and mean oxygen saturation were observed among both of groups on intergroup comparison intraoperatively and post operatively up to 24 hour (p >0.05) The findings of the present study were consistent with the following study. Savita gupta and Rasmi sharma et al.. , in their study to compared the analgesic efficacy of caudal dexmedetomidine versus caudal tramadol with ropivacaine 0.25% in 60 children aged 1 to 8 yrs for paediatric infra-umbilical surgeries. S.Prakash et al.17 , Shrestha S.K. et al.9, Nasreen laiq10 and Senel AC et al.16, Choudhuri A.H. et al.19 and Doda M,Mukherjee S, in their study on addition of tramadol to bupivacaine 0.25% in caudal anaesthesia, have reported no significant changes in haemodynamic parameters which correlates with our study. Goyal V, Kubre Jand Ramsay sedation score-. The findings of the above present study were consistent with the following study. savita gupta and Rasmi sharma , compared the analgesic efficacy of caudal dexmedetomidine (2ug/kg) versus caudal tramadol (2mg/kg) with ropivacaine (0.25%,1ml/kg) in 60 children aged 1 to 8 yrs for paediatric infra-umbilical surgeries. Ramsay sedation scoring were done at end of surgery, then hourly till 6 hour. mean sedation score were significantly high in group BD compared to group BT . Saadaway I et al. in their study on effect of dexmedetomidine(1ug/kg) on the bupivacaine (0.25%, 1ml/kg) in a caudal block in pediatrics, Sedation was rated with Ramsay’s sedation scale. they concluded that the duration of sedation was prolonged in group BD(210±72 min) compared with group B (24±72min). Solanki N M et al.., in their study of comparison of caudal tramadol(2mg/kg) versus caudal fentany l(2ug/kg) with bupivacaine (0.25%, 1ml/kg) for prolongation of post-operative analgesis in pediatrics, sedation was rated with four-point sedation score. They concluded that duration of sedation was prolonged in group BF(2hr) than group BT(˂1 hr). So sedation with caudal tramadol was below one hour. which well co-related with our study. Face, Leg, Activity, Cry, Consolability (FLACC) pain score- To assess the quality and duration of analgesia, Post-operative pain assessment was done using FLACC scoring system in our study. Merkel et al. evaluated FLACC scoring for assessing pain in children and found that it is reliable and valid in quantifying pain in non-verbal children. FLACC score was analysed between the two groups at various interval of time at end of sx, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr ,6hr, 9hr, 12hr, 18hr, 24hr postoperatively. the effective analgesia lasted longer in bupivacaine with dexmedetomidine when compared to bupivacaine with tramadol group.In present study, Group BT patients achieved statistically significantly higher FLACC score compared with Group BD.(p˂0.05) The findings of the above present study were consistent with the following study. Savita Gupta and Rasmi Sharma et al., Goyal V, Kubre J and Radhakrishnan K et al., Hannawy et al., Regmi UK et al., Essam Shafiq M et al. (2012)2 Duration of analgesia: The findings of the above present study were consistent with the following study. Savita gupta and Rasmi sharma et al., compared the analgesic efficacy of caudal dexmedetomidine (2 ug/kg) versus caudal tramadol (2 mg/kg) with ropivacaine in 60 children aged 1 to 8 years for paediatric infra-umbilical surgeries. the mean duration of analgesia was 10.9±1.30 hr in group BT and 13.00±1.19 hr in group BD. so caudal dexmedetomidine provided longer duration of analgesia than caudal tramadol.
CONCLUSION Caudal block in pediatric infra-umbilical surgery is very beneficial to produce longer duration and powerful analgesia. Caudal Dexmedetomidine 1 µg/kg with 0.25% bupivacaine 1 ml/kg provided significant post-operative pain relief up to 13.2±2.8 hrs with prolonged duration of arousable sedation. Comparable, while using caudal tramadol 1 mg/kg with 0.25% bupivacaine also provided significant post-operative pain relief up to 6.9±1.2 hrs but less duration than Dexmedetomidine. All patients remained hemodynamically stable perioperatively in present study. We concluded that Dexmedetomidine offers some advantage over tramadol as it does produce clinically and statistically significant prolonged duration of post-operative pain relief and tranquility. Thus dexmedetomidine with bupivacaine can be used as an alternative to tramadol with bupivacaine for paediatric infre-umbilical surgeries through the caudal route as a safe and effective agent.
REFERENCES
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