Table of Contents  
ORIGINAL ARTICLE
Year : 2014  |  Volume : 7  |  Issue : 4  |  Page : 514-517

The analgesic efficacy of preincisional peritonsillar versus intravenous ketamine with bupivacaine infiltration for tonsillectomy in children: a randomized double-blind controlled study


1 Department of Anaesthesia and Intensive Care, Mansoura University, Mansoura, Egypt
2 Department of Otolaryngology, Mansoura University, Mansoura, Egypt

Date of Submission11-Feb-2014
Date of Acceptance18-Feb-2014
Date of Web Publication28-Nov-2014

Correspondence Address:
Nahla S El Bahnasawy
Department of Anaesthesia and Intensive Care, Mansoura University, Mansoura
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1687-7934.145685

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  Abstract 

Objective
This study aimed to evaluate the postoperative analgesic efficacy of either preincisional peritonsillar infiltration of ketamine in combination with bupivacaine, or intravenous ketamine combined with infiltration of bupivacaine.
Patients and methods
A total of 60 patients were randomized into three groups: intravenous group, in which patients received intravenous ketamine (0.5 mg/kg) in 10 ml plus peritonsillar infiltration of bupivacaine 2 ml (5 mg/ml); infiltration group, in which patients received peritonsillar infiltration of ketamine (0.5 mg/kg) in 2 ml plus bupivacaine 2 ml and intravenous 10 ml saline; and placebo group, in which patients received 10 ml intravenous saline and peritonsillar infiltration of 2 ml saline plus 2 ml bupivacaine 2 ml/tonsil. The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Wilson scale were used to evaluate pain and sedation, respectively. Time to first analgesic request and total analgesic request, total analgesic consumption during 24 h postoperatively, intraoperative blood loss, and adverse effects were evaluated.
Results
Time to analgesic request was significantly prolonged in the intravenous and infiltration groups (4.3 ± 2.1 and 11.6 ± 3.6 h, respectively) compared with the placebo group (1.2 ± 1.2 h), with significant prolonged time in the infiltration group compared with the intravenous group. Significant lower (CHEOPS) scores and significant lower analgesic consumption were observed in the intravenous and infiltration groups (69 ± 4.1 and 45.1 ± 2.1 mg), respectively, compared with the placebo group (90.6 ± 5.3 mg). Both the intravenous and infiltration groups had comparable pain scores, with statistical significance at 4, 6, and 8 h postoperatively. Dysphagia was significantly higher in the placebo group compared with the intravenous and infiltration groups. No serious complication was reported in the three groups.
Conclusion
Intravenous or peritonsillar infiltration of ketamine with bupivacaine enhanced post-tonsillectomy analgesia in children. In comparison, the analgesic efficacy of infiltration of ketamine was superior to intravenous administration, without significant side effects.

Keywords: analgesia, bupivacaine, children, ketamine, tonsillectomy


How to cite this article:
El Bahnasawy NS, Abu-Samra M. The analgesic efficacy of preincisional peritonsillar versus intravenous ketamine with bupivacaine infiltration for tonsillectomy in children: a randomized double-blind controlled study. Ain-Shams J Anaesthesiol 2014;7:514-7

How to cite this URL:
El Bahnasawy NS, Abu-Samra M. The analgesic efficacy of preincisional peritonsillar versus intravenous ketamine with bupivacaine infiltration for tonsillectomy in children: a randomized double-blind controlled study. Ain-Shams J Anaesthesiol [serial online] 2014 [cited 2023 Nov 28];7:514-7. Available from: http://www.asja.eg.net/text.asp?2014/7/4/514/145685


  Introduction Top


Tonsillectomy is among the most frequently performed pediatric day case procedure that is associated with significant postoperative pain. Various pharmacological agents have been used to avoid undertreatment of pain in children [1]. Opioid analgesics and NSAIDs have been associated with increased risk of respiratory depression and postoperative bleeding, respectively [2]. Peritonsillar infiltration of local anesthetics results in less postoperative pain [3]. Intraoperative infiltration with long-acting amide anesthetic bupivacaine has been used before tonsillectomy and has proven to be effective in reducing early postoperative pain [4]. However, combining local anesthetic agents with other drugs has met with varied degrees of success [5]. Ketamine is an NMDA receptor antagonist, which when administered by peritonsillar infiltration, provides efficient pain relief in children after adenotonsillectomy [6]. Preoperative intravenous ketamine has proven to be an efficient postoperative pain relief after adenotonsillectomy in children [7].

We hypothesized that adding ketamine to bupivacaine by two routes, either intravenously or peritonsillar infiltration, may provide more prolonged and superior analgesia. This prospective study was conducted to compare preincisional peritonsillar versus intravenous ketamine in combination with bupivacaine infiltration for post-tonsillectomy analgesia.


  Patients and methods Top


The current study was conducted at Mansoura University Hospital from March to December 2012. After approval from the local ethical committee, 60 patients of ASA physical status I or II aged 6-10 years, scheduled for tonsillectomy because of recurrent or chronic tonsillitis, were enrolled for this double-blind randomized controlled study. Written informed consent was obtained from the parents of each patient. Exclusion criteria included known allergy to bupivacaine or any drug used in the study, the presence of severe systemic or endocrine disease, the presence of coagulation disorder, psychiatric disorders, and the presence of painful condition of oropharnyx such as peritonsillitis and peritonsillar abscess. All patients were fasted for 6-8 h before anesthesia. After inserting intravenous line, lactated Ringer's solution was started and monitors (noninvasive blood pressure, ECG, and pulse oximeter for SpO 2 ) were used. Patients were randomly allocated using computer randomization list and closed envelop technique into three groups with 20 patients in each group to receive either ketamine (0.5 mg/kg, intravenously) (intravenous group), peritonsillar infiltration of ketamine (0.5 mg/kg) in 2 ml (infiltration group), or saline (placebo group). Patients received a standardized anesthetic technique that included induction with propofol (2-3 mg/kg intravenously), and atracurium (0.5 mg/kg intravenously) to facilitate endotracheal intubation with suitable sized cuffed tube. Fentanyl (1-2 μg/kg) was administered as an analgesic agent before infiltration. Anesthesia was maintained with isoflurane in oxygen/air mixture. Patients were mechanically ventilated in ventilation parameter that maintained an end-tidal carbon dioxide (EtCO 2 ) around 30-35 mmHg. An anesthesiologist prepared syringes containing study medication, either intravenous solution in 10 ml or infiltration solution in 4 ml (2 ml for each side). After the induction of anesthesia before the start of surgery, patients in the placebo group received 10 ml of normal saline intravenously and bupivacaine 2 ml (5 mg/ml) plus 2 ml saline peritonsillar infiltration. In the ketamine intravenous group, patients received intravenous ketamine (0.5 ml/kg) in 10 ml with peritonsillar infiltration of bupivacaine 2 ml (5 mg/ml) plus 2 ml saline. In the ketamine infiltration group, patients received intravenous saline 10 ml with peritonsillar infiltration of bupivacaine 2 ml (5 mg/ml) plus ketamine (0.5 ml/kg) diluted in 2 ml. Infiltration solution was infiltrated pericapsulary through the tonsillar bed and peritonsillar tissues in a fanwise direction from the superior to inferior poles of the fossa (2 ml each side), using a 25-G spinal needle. The surgeon, anesthetist, and the physician who collected the data were blinded to the patient group assignment. At the end of the surgery, anesthesia was discontinued, and the residual effect of muscle relaxant was reversed with neostigmine (0.04 mg/kg) and atropine (0.02 mg/kg). The tracheal tube was removed in the lateral position and then oxygen was administered through a face mask to the patient.

Intraoperative blood loss was roughly estimated of the blood lost in suction bottles and counting number of swabs. After extubation, patients were shifted to the postanesthesia care unit (PACU). In the PACU, an anesthetist and a nurse who were unaware of the study group observed the patient. Noninvasive blood pressure, heart rate, ECG, and oxygen saturation (SpO 2 ) were monitored. Pain scores were assessed at 30 min, 1, 2, 4, 6, 8, 12, and 24 h postoperatively using Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) [8]. A score of 4 or more, rescue analgesia was administered as diclofenac sodium (1 mg/kg) intramuscularly. The total consumption of the rescue analgesics in the first 24 h was recorded. Time to first rescue analgesia was recorded for each patient. Postoperative sedation was assessed by Wilson sedation scale [9] at 30 min, 1, and 2 h in the PACU. Patients were discharged to the ward after obtaining an Aldrete and Kroulik score of greater than 9 [10]. Postoperative complications such as nausea, vomiting, hallucination, and dysphagia for solid or liquid were recorded. Metoclopramide (0.1 mg/kg) intravenously was administered to the patient having nausea or vomiting. On discharge, patients were prescribed acetaminophen syrup (15 ml/kg) orally on a 6-h basis as needed for analgesia.

Statistical analysis

Sample size was calculated by using Fisher's exact test for proportions. On the basis of a pilot study on 10 patients of each group, the proportion of patients for the duration of analgesia in the placebo group was 4%, and the proportion in the infiltration group was 45%. Sample size was calculated as 20 patients for each group, when α-error P-value was 0.05 and the actual power of study was 85%.

The statistical analysis was carried out using the Statistical Package for Social Sciences 16 (SPSS Inc., Chicago, Illinois, USA). Results are expressed as mean ± SD, median (range), or numbers. The data were tested for normality using Kolmogorov-Smirnov normality test. χ2 -Test or Fisher's exact test were used as appropriate to analyze categorical variables. Nonparametric data were compared using Mann-Whitney U-test. Repeated measurements were analyzed by repeated-measures analysis of variance, if normally distributed. For non-normally distributed data, the Wilcoxon's rank-sum test was used to compare between groups at each time point. A P-value less than 0.05 was considered statistically significant.


  Results Top


There was no statistically significant difference between the groups for age, weight, sex, duration of anesthesia, and duration of surgery ([Table 1]). No statistical significant differences were observed in heart rate, oxygen saturation, EtCO 2 , systolic, and diastolic blood pressure, intraoperatively and postoperatively.
Table 1 Demographic data and durations of surgery and anesthesia

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Time to first analgesic request was significantly longer in both the intravenous group and infiltration group compared with the placebo group (P = 0.001). However, there was significant prolonged time of first analgesic request in the infiltration group compared with the intravenous group (P = 0.001) ([Table 2]). Total diclofenac consumption in the first 24 h was significantly less in the intravenous group and infiltration group compared with the placebo group (P = 0.01). There was statistically significant decrease in diclofenac consumption in the infiltration group compared with the intravenous group (P ≤ 0.05) ([Table 2]). Patients of the placebo group had higher pain (CHEOPS) scores than the intravenous and infiltration groups, starting from 2 h postoperatively in all studied events ([Table 3]). The intravenous group had pain (CHEOPS) scores that were statistically significantly higher at 4, 6, and 8 h compared with the infiltration group ([Table 3]). Postoperative assessment of sedation by the Wilson sedation scale showed statistically insignificant difference between the three groups. The studied groups achieved a score of 1 (awake and oriented) within 1 h in the PACU. There was no pronounced sedation or hallucination. There was no significant difference among the three groups regarding intraoperative blood loss and postoperative nausea and vomiting ([Table 4]), whereas postoperative dysphagia was significantly higher in the placebo group compared with the intravenous group and infiltration group. However, there was a significant decrease in the number of patients complaining of dysphagia in the infiltration group compared with the intravenous group ([Table 4]).
Table 2 Postoperative pain profi le

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Table 3 Postoperative pain (CHEOPS) scores

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Table 4 Intraoperative blood loss and postoperative complications

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  Discussion Top


The current study demonstrated that both ketamine administered both intravenously and by peritonsillar infiltration ketamine, in addition to local infiltration of bupivacaine, before the start of tonsillectomy surgery, enhanced postoperative pain relief, prolonged time to rescue analgesia, and reduced the need for postoperative analgesia. Although intravenous ketamine was better than placebo, it lagged behind peritonsillar infiltration of ketamine in the analgesic efficacy. These results were in agreement with a study by Honarmand and Reza [6] that showed that low-dose peritonsillar infiltration of ketamine provides efficient pain relief during 24 h postoperatively, without significant side effects. In accordance with the present study, Aspinall and Mayor [11] administered intravenous ketamine (0.5 mg/kg) and provided effective analgesia for the immediate postoperative period after adenotonsillectomy, with no increased risk of side effects, but with increased incidence of suffering pain at home, meaning short postoperative analgesia. Ketamine has its peripheral and central effects. During peritonsillar infiltration, ketamine shows its local analgesic effect by block of sodium and potassium channels in the tonsillar nerve [12]. In this study, adding ketamine infiltration with bupivacaine peritonsillar infiltration prolonged the analgesia period. This finding signified that both the drugs provided analgesia through another local mechanism other than nerve block. Oral ketamine provides ineffective analgesia postoperative and causes more salivation, whereas intramuscular ketamine produces sedation and reduces pain on swallowing but with ineffective postoperative analgesia [13]. Another route of analgesic effect of ketamine is rectal administration, especially in the first few hours after surgery compared with acetaminophen, and therefore it can be administered as an alternative analgesic in the immediate postoperative period [14]. During systemic, local, or caudal administration of ketamine, the analgesic effect of this drug was observed in the PACU and was not associated with an opioid-sparing effect [15]. Intravenous ketamine produces efficient analgesia and decreases analgesic requirements when used before day case surgery [16]. Khademi et al. [17] proved that peritonsillar infiltration of ketamine is more effective in reducing postoperative pain than the intravenous route in children undergoing adenotonsillectomy [7]. However, in our study, adding bupivacaine to peritonsillar ketamine provided more effective analgesia than peritonsillar bupivacaine with intravenous ketamine. Despite systemic absorption of ketamine by the two routes, in the present study, no pronounced sedation or hallucination, the most common side effects of ketamine, were observed. Swallowed blood, pain, and direct oropharyngeal irritation may contribute to postoperative nausea and vomiting after tonsillectomy [18]. In this study, no statistical significant differences were observed in the incidence of nausea or vomiting; however, dysphagia was significant in the placebo group and was significantly less in the infiltration group because of the combined effect of peritonsillar bupivacaine and ketamine. No patient in this study suffered from any serious complication or required reoperation for bleeding.


  Conclusion Top


Intravenous or peritonsillar infiltration of ketamine with bupivacaine enhanced postoperative analgesia after tonsillectomy in children. In comparison, the analgesic efficacy of locally applied ketamine was superior to the intravenous administration without significant side effects.


  Acknowledgements Top


 
  References Top

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Naja MZ, El Rajab M, Kabalan W, et al. Pre-incisional infiltration for paediatric tonsillectomy. A randomized double-blind clinical trial. Int Pediatr Otorhinolaryngol 2005; 69:1333-1341.  Back to cited text no. 3
    
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Aspinall RL, Mayor A. A prospective randomized controlled study of the efficacy of ketamine for postoperative pain relief in children after adenotonsillectomy. Paediatr Anaesth 2001; 11:333-336.  Back to cited text no. 11
    
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Heidari SM, Mirlohi SZ, Hashemi SJ. Comparison of the preventive analgesic effect of rectal ketamine and rectal acetaminophen after pediatric tonsillectomy. Int J Prev Med 2012; 3:S150-S155.  Back to cited text no. 14
    
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]


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