Of all the ENT surgeries performed in children, tonsillectomy/adenotonsillectomy is the commonest surgery. Significant pain associated with tonsillectomy is reported in 20-50% of children undergoing tonsillectomy [1]. Pain can be devastating to the child, which hinders mastication and swallowing, hence affecting its nutrition, longer hospital stays, longer duration of abstinence from school. If postoperative pain is controlled in the best possible way it may smoothens the recovery period. Despite the use of various surgical techniques adequate postoperative analgesia is still a challenge [2]. Systemic analgesics and opioids though frequently used may have undesired side effects like respiratory depression can be hazardous after tonsillectomy. These adverse effects justify investigators to develop alternate strategies for analgesia. Topical approaches have the advantage of local pain control with minimal systemic side effects and good patient acceptability. Local anaesthetics, anti-inflammatory agents and opioids are given in solution form by rinsing the oral cavity for oropharyngeal pain control [3]. Tramadol is a µ1, noradrenergic, and serotonergic agonist. In addition to the systemic effect, the local analgesic effect of tramadol on peripheral nerves has [4] been shown in laboratory and clinical studies. Different local anesthetics can be used for infiltration but the ropivacaine which has least neuro and cardio toxicity and selective sensory effect will be the better choice. Ropivacaine was studied for analgesia after tonsillectomy locally in different concentration 0.25%, 0.50% and 1%, it significantly relieves post-tonsillectomy pain in the pediatric population and also reduces postoperative analgesic requirement [5,6]. Furthermore, no studies have compared the effects of 0.75% topical ropivacaine and 0.75% topical ropivacaine with tramadol administration in a randomized controlled trial. Thus, purpose of this study was to compare the efficacy of topical ropivacaine and topical ropivacaine with tramadol on post-operative morbidity in pediatric patients after tonsillectomy.

A double blind, prospective, randomized, controlled clinical trial was designed and approved by the faculty of ethics committee. 60 patients of either sex, aged 4-14yr posted for tonsillectomy under general anesthesia were enrolled in this study according to following criteria. Inclusion Criteria: 1. Age of patient: 4-14 years 2. Gender: male and female 3. Patients posted for tonsillectomy under general anesthesia 4. ASA Grade I & II Exclusion Criteria: 1. Acute pharyngeal infection 2. Peri-tonsillar abscess 3. Cardiovascular, renal or liver disease 4. Neurological or psychiatric disease 5. Coagulation disturbances 6. Allergy to local anaesthetic Patient were randomized into 2 groups, Group RT (Ropivacaine + Tramadol) Ropivacaine 0.75% 5ml + tramadol 2 mg/kg were applied in tonsillar fossa for 5 min. Group R (Ropivacaine) Ropivacaine 0.75% 5ml were applied in tonsillar fossa for 5 min. using computer generated random number sequence method. Patients were blinded about the group in which they were enrolled. Patients and parents were explained for Visual Analogue Scale (VAS) during pre anaesthetic check-up. Visual analogue scale (VAS) The visual analogue scale is represented as a straight line usually 10 cm in length: 0-No pain and 10-worst pain ever (as shown in Fig. 1). For children it could be simplified by adding pictures. Child places a slide corresponding to the degree of pain they feel. This seems to be the most sensitive method. This method has been used in this study for pain score assessment in children. After thorough pre-anesthetic evaluation and appropriate fasting according to age, all patients were given oral midazolam 0.5 mg/kg (preservative free midazolam hydrocloride syrup 2mg/ml; 10 minutes before intravenous cannulation. Routine monitoring (ECG, noninvasive blood pressure, pulse rate, oxygen saturation and temperature) was used. Patient was premedicated with glycopyrrolate (0.01mg/kg), ondansetron (0.1mg/kg) given intravenously. After induction with intravenous propofol 2 mg/kg and atracurium 0.5 mg/ kg, patient was intubated with an appropriate sized, cuffed, naso-tracheal tube under direct laryngoscopy using magill forceps. Oropharyngeal packing was done using sterile cotton roll soaked in distil water, anaesthesia was maintained with oxygen, nitrous oxide, sevoflurane, intermittent atracurium and intermittent positive pressure ventilation. After tonsillectomy but before reversal, swabs soaked in Ropivacaine 0.75% 5ml plus tramadol 2 mg/kg (Group RT) or Ropivacaine 0.75% 5ml (Group R) were applied in tonsillar fossa for 5 min. After completion of the surgery, neuromuscular blockade was reversed using inj.neostigmine 0.05 mg/kg and inj.glycopyrolate.008 mg/kg. After removing oral pack patient was extubated after fulfillment of the clinical criteria for extubation and thorough oropharyngeal suction. Patient was given secretion draining position and shifted to post anaesthetic care unit Oxygen was supplemented for 2 hours post operatively when child was able to maintain Spo2 >95% on air it was discontinued. After the surgery patients were sifted to PACU room and when fast tracking score of ≥ 12 they were shifted to ward. Patient’s were monitored for PR and Sp02 (pulseoximeter),blood pressure, post-operative pain, pain on deglutination,time to first analgesic requirement, total dose of analgesics requirement in 24 hours postoperatively, amount of bleeding and parent’s satisfaction score and complication if any at 30min,1hr and 2hr, 4hr, 10 hr, 16hr and 24hr. The time of application of topical swabs at tonsillar site at the end of surgery was considered as 0 hrs. Post tonsillectomy pain was assessed subjectively using VAS score and objectively by CHEOPS (Table 1). The rescue analgesia was given in post-operative period when VAS (Visual analogue score) ≥ 4 or/and CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) ≥5 in the form of Inj. Paracetamol 10 mg/kg. The time to first analgesia and total analgesic requirement in 24 hours was also calculated. Pain on deglutition, amount of bleeding and parent’s satisfaction score were monitored with verbal rating scale (VRS) Verbal Rating Scale (VRS) 1. Mild, 2. Moderate, 3. Sever Sample size calculation assuming α error being 0.05 and β error being 0.2with a power of study 80% showed that 30 patient was required per study. Data were entered and analysed with the help of MS Excel, EPi info 6 and SPSS 12.0Frequencies and percentages were calculated and p-value was established to find a statistical difference between the variables. The significance level was set at p value<0.05. Chi-square test was also applied for the analysis.

There were no statistically significant differences between age, gender, body weight, and duration from induction to placement of swabs(P>0.05) (Table 1). Table-1 Distribution of patients according to demographic parameters Group T (n=28) Group C (n=28) P-value Age (yrs) 9.78±2.09 8.21±2.33 0.10(NS) Sex (M/F) 17/11 16/12 0.56(NS) Body weight (Kgs) 13.96 ± 4.86 15.44 ± 4.53 0.86(NS) Duration from induction to placement of swabs (mins) 39.87 ± 11.62 38.11 ± 9.92 0.2(NS) NS - Not Significant VAS score (Fig. 1) and CHEOPS score (Table 2) was comparable in both the groups at 30minute, 1 hour and 2 hour (P > 0.05) and it was significantly low in group RT compare to group R at 4-hour, 10-hour, 16-hour and 24 hour (P Value < 0.05). Time for first analgesic requirement is comparable in both the groups (P > 0.05). (Table 3). Total number of patients required analgesia was significantly low in group RT compare to group R (Table 4). Total analgesic consumed in group RT (31±82.8) mg and is significantly low as compare to that in group R (214.6±142.8) mg (P < 0.05). Post-operative pain on deglutition was significantly lower in group RT compare to that in group R (P <0.05). Post-operative bleeding was significantly low in group in RT (1.13±0.43) as compare to that in group R (2±0.26) (P <0.05). Parent’s satisfaction score was significantly more in group RT (2.80±0.40) as compare to that in group R (1.96±0.31) (P <0.05). Fig. 1: VAS scale Table-2 CHEOPS Score Parameter Finding Score Cry No crying Moaning Crying Screaming 1 2 2 3 Facies Smiling Neural facial expression Grimace 0 1 2 Verbal Positive None Complain other than pain Pain complains Pain and non-pain complain 0 1 1 2 2 Torso position Inactive torso Shifting Tense arched or rigid Shivering Upright Restrained 1 2 2 2 2 2 Touch No touching of the painful area Trying to reach but not touching painful area Touching the painful area Grabbing the painful area 1 2 2 2 Legs Legs at rest Squirming/kicking Drawn up or tense Standing, kneeling or squatting Restrained 1 2 2 2 2 SUM (points for all 6 parameters) Interpretation: • Minimum score: 4 • Maximum score: 13 Table 3: Time for first analgesic intake Group R (n=30) Mean ± SD Group RT (n=30) Mean ± SD P Value 9.83±4.75 11.5±3.00 0.506 Table 4: Total number of patients required analgesia Time Group R n=30 Number of patients required analgesia Group RT n=30 Number of patients required analgesia 30 minutes 0 0 1 hour 0 0 2 hour 0 0 4 hour 07 (23.33%) 0 10 hour 16 (53.33%) 04 (13.33%) 16 hour 02(6.66%) 01(3.33%) 24 hour 01(3.33%) 0

Pain after tonsillectomy is a very agonising and an unpleasant experience for both, patients as well as the parents in the perioperative period. Throat pain, referred otalgia and bleeding after tonsillectomy contribute to making recuperation prolonged. It is thus necessary to provide adequate analgesia, to relieve the agony of pain and reduce incidence of bleeding since increased vascular congestion of head and neck associated with crying may precipitate bleeding. The oropharynx and the tonsillar fossae are exquisitely sensitive. They are well innervated locally by the branches of the trigeminal and glossopharyngeal nerves and are highly represented in the somatic cerebral cortex.[7] During surgery, pain impulses entering the central nervous system, creates a hyperexcitable state in spite of general anesthesia. Blockage of these impulses by preoperative analgesic drugs, infiltration or topical administration of various groups of drugs have preemptive analgesic effect. With regards to the results of the cited studies, there exist three different ways of applying the local anesthetics: pre-incisional peritonsillar infiltration [8,9] post-tonsillectomy wound infiltration [10,11] post-tonsillectomy packing with soaked local anesthetic gauze [12]. The technique of infiltration itself was not standardised in the literature and may not be as safe because of the neurovascular bundle in the vicinity that could explain high potential for side-effects. Indeed, three studies have reported complications [12] including arrhythmias; bleeding; intravascular injection, and sedation. Topical application of drugs in the tonsillar fossae for postoperative analgesia after tonsillectomy has been evaluated previously using various local anesthetic like lignocaine, bupivacaine, ropivacaine and it was found that ropivacaine is superior to other local anesthetic agent as it is less lipophilic than bupivacaine and is less likely to penetrate large myelinated motor fibers, resulting in relatively reduced motor blockade thus has a greater degree of motor sensory differentiation which could be useful when motor blockade is undesirable as in peri-tonsillar fossa [110,11,12]. Motor blockade in peri-tonsillar fossa may result in difficulty in deglutition due to paralysis of pharyngeal muscle. Tramadol is a typical centrally acting non-opioid analgesic with a variety of mechanisms of action including weak to negligible opioid effects. Its effect is equivalent when orally or intramuscularly administered. Its analgesic effect is weaker than that of morphine and roughly half of that of codeine but it has no adverse effects such as respiratory depression or constipation. Schnabel et al. found that the use of tramadol immediately after surgery for pediatric patients had good analgesic effect, could alleviate agitation due to pain and discomfort, and did not cause delayed recovery of consciousness [12] Oghan F[9] et al (2008) used 1% ropivacaine hydrochloride-soaked swabs packed in tonsillar fossae in the test group and the control group received saline-soaked swabs. The main outcome measure was severity of pain by using visual analogue score. There was significant difference between subject and control fossae scores at all the stages up to discharge of patients, showing better pain relief with ropivacaine P<0.05. Only at first hour there was no significant pain-relieving effect seen in ropivacaine group (P>0.05). The other hours and days there were statistically significance between the two groups (P<0.001). Akbay et al[3] (2010) used swabs soaked in 2mg/kg tramadol diluted in 10ml saline and applied to both tonsillar fossae for 5 min (Tramadol group) and compared it with swabs soaked in 10 ml saline (saline group). McGrath‟s face scale (happy–sad nine-face scale) was used for pain assessment. Pain scores were found to be significantly lower at the 21st hour and on postoperative day seven in the tramadol group compared with the control group (P < 0.05). Mean daily pain scores ranged from Day 1: 0.34 ± 0.21 to Day 7: 0.11 ± 0.08 in the tramadol group and Day 1: 0.53 ± 0.14 to Day 7: 0.42 ± 0.15 in the control group. In the present study analgesic consumption in 24 hours was significantly lower in group RT group as compared to R group and results are comparable with a study,[18] In our study postoperative pain scores were significantly low in the (Group RT) as compared (Group R) at the 4th , 12th , 18th , 24th hr postoperatively (P<0.001). Pain scores were comparable in the rest of the hours and days, P>0.05. The difference in rescue analgesic requirement was highly significant, P<0.001.The total number of doses of rescue analgesic was significantly higher in Group R as compared to Group RT, P<0.001. This pattern of delayed and longer duration analgesic effect might probably be because of using topical tramadol as additive to the tonsillar fossa. We did not found any complication in any case. The factor that could limit our results is variation in surgeon, being in teaching institute we could not keep single surgeon for all tonsillectomy surgery. As there were no studies which have compared postoperative topical application of ropivacaine with or without topical tramadol more clinical trials needed for the global acceptance of this study.

We conclude that topical application of 0.75% ropivacaine for 5 min after tonsillectomy in the tonsillar bed is an effective and safe method for post tonsillectomy pain relief, however addition of tramadol as an adjuvant further increases its efficacy, increases time for first analgesic requirement, decreases total analgesic requirement, decreases pain on deglutition, decreases amount of bleeding and increases parents satisfaction score without added complication

[1]. Kotiniemi LH, Ryhanen PT, Valanne J, Jokela R, Mustonen A, Poukkula E. Postoperative symptoms at home following day-case surgery in children: a multicentre survey of 551 children. Anesthesia 1997; 52:963-9. [2]. Vasan NR, Stevenson S, Ward M. Preincisional bupivacaine in post-tonsillectomy pain relief: a randomized prospective study. Arch Otolaryngol Head Neck Surg 2002; 128:145-9. [3]. Akbay BK, Yildizbas S, Guclu E, Yilmaz S, Iskender A, Ozturk O. Analgesic efficacy of topical tramadol in control of postoperative pain in children after tonsillectomy. J Anesth 2010; 24:705-708. [4]. Mert T, Gunes Y, Guven M, Gunay I, Ozcengiz D. Comparison of nerve conduction blocks by an opioid and a local anesthetic. Eur J Pharmacol 2002; 439:77–81. [5] Cook SP: Bupivacaine injection to control tonsillectomy pain. Arch Otolaryngol Head Neck Surg 2001;127:1279. [6] Murthy P, Laing MR. Dissection tonsillectomy: pattern of post-operative pain, medication and resumption of normal activity. J Laryngol Otol 1998;112:41-4. [7]. Merkel SI, Voepel LT, Shayevitz JR, Malviya S. The FLACC: A behavioral scale for scoring postoperative pain in young children. Pediatric Nursing 1997; 23(3):293–297. [8]. Hollis LJ, Burton MJ, Millar JM. Perioperative local anaesthesia for reducing pain following tonsillectomy. Cochrane Database Syst Rev 2000; (2):CD001874. [9]. Goldsher M, Podoshin L, Fradis M, Malatskey S, Gerstel R, Vaida S. Effects of peritonsillar in infiltration on post-tonsillectomy pain. A double-blind study. Ann Otol Rhinol Laryngol 1996; 105(11):868-870. [10].Jebeles JA, Reilly JS, Gutierrez JF, Bradley EL Jr, Kissin I. The effect of pre-incisional infiltration of tonsils with bupivacaine on the pain following tonsillectomy under general anesthesia. Pain 1991; 47(3):305–308. doi:10.1016/0304-3959(91)90220-R. [11]. Kountakis SE. Effectiveness of perioperative bupivacaine infiltration in tonsillectomy patients. Am J Otolaryngol 2002; 23(2):76– 80. doi:10.1053/ajot.2002.28771. [12]. Kadar A A, Obaid M A. Effect on postoperative pain after local application of bupivacaine in tonsillar fossa, a prospective, single blind, controlled trail. Journal of Pakistan Medical Association 2003; 53: 195-