Comparative study on Post Tonsillectomy use of Antibiotics and Placebo

Tonsillectomy is the most frequently performed surgical procedure in Otolaryngological practice. We included 110 patients and divided into antibiotic group and placebo group, and followed up upto 7th POD. Parameters of observation were pain, fever, nausea & vomiting, reactionary & secondary haemorrhage, duration of hospital stay and return to normal diet. The result of this study showed that post operative pain and return to normal diet improved in antibiotic treated group than those who received placebo, but there is no statistically significant difference between two groups in respect of fever, nausea & vomiting, reactionary & secondary haemorrhage and duration of hospital stay.


Introduction:
Tonsillectomy, whether or not combined with adenoidectomy is one of the most common frequently performed surgical procedures in the world, with higher prevalence among the pediatric population. The main current indications for tonsillectomy and adenotonsillectomy are recurring infections and blockages of the upper airways, which may possibly lead to serous otitis, repetition otitis media, rhinosinusitis, snoring, sleep apnea that often compromising the child's development and performance at school. 1 There have been great developments in the surgical field in the form of surgical technique and anesthesia, but postoperative morbidity is yet an important factor to be considered. Several papers have looked into drugs to minimize postoperative morbidity, such as steroids administered during anaesthesia or postoperative analgesics such as paracetamol, diclofenac and tramadol, and postoperative antibiotics 1 .
The most significant post tonsillectomy morbidity arises from bleeding and pain. Secondary haemorrhage is now more common than primary and particularly so in adults. The exact cause of post tonsillectomy haemorrhage is not still clear but commonly attributed to infection. 2 Antibiotics are frequently prescribed in the perioperative and post-operative time periods since many of the previously signs and symptoms are thought to be due to infection. 3 Although some studies have shown antibiotics to be beneficial in reducing post-tonsillectomy morbidity, there is still no consensus on the matter. 1

Antibiotic Therapy:
After admission, the patients were being allocated into two groups by coin flipping method. Both groups received inj. Cefradineperoperatively(15mg/kg body wt.) The case group received Placebo (A capsule that resemble antibiotic capsule but not antibiotic) whereas control group received antibiotic Cefradine (15mg/kg body wt.) in post-operative period for 7 days. Other supporting treatment is same for both groups such as analgesics (Paracetamol thrice daily and Diclofenacsodium if required), antiseptic mouthwash (diluted Hydrogen peroxide)

Data Collection:
Relevant data were collected in a pre designed data collection sheet for each of the patient admitted in Dhaka Medical College Hospital Dhaka admitted for Tonsillectomy operation. Informed consent were obtained from the patient him or herself or from the legal guardian of the patient prior to entry into the trial. The patients were randomly allocated into two groups by coin flipping. Control group received a week of Cefradine post-operatively and case group received placebo. Doses were according to the British National Formulatory 1996 edition and were followed up at 1 st , 2 nd 3 rd , 5th, 7th postoperative day. During each visit they were subjected to routine examination such as examination of the tonsillar fossa, temperature, pulse rate. The subjective and objective evaluations were carried out by asking the patients whether the symptoms are present or not. Data were collected in terms of demographic and clinical variables. Pain was assessed by Visual analogue Pain Scale .       Regarding the comparison of pain on the 1 st , 2 nd and 3 rd post-operative day in placebo or no antibiotic group and antibiotic group found statistically insignificant. On the 5 th postoperative day 5 patients from placebo or no antibiotic group and 18 patients from antibiotic group had no pain. 30 and 17 patients from placebo group and 24 and 16 from antibiotic group of experienced mild and moderate pain respectively. On comparison between placebo group and antibiotic group, antibiotic group was found better than placebo group. P value was 0.02. That is statistically significant. It indicates that pain significantly reduces in the patients who took antibiotic after tonsillectomy. On the 7 th day in placebo group 9(17.3%) patients had no pain, 30(57.7%) had mild pain, 13(25%) had experience moderate pain. And in the control group 20(34.5%), 33(56.6%) and 5(8.9%) patients experienced no pain, mild pain and moderate pain respectively. Pain was found statistically significant. Statistical analysis shows that postoperative pain in antibiotic group significantly reduced from 5 th /7 th postoperative day than those who received placebo. MP Colvery et al. demonstrated that postoperative pain and analgesics consumption were significantly higher in nonantibiotic treated patients. 6 Three studies reported results regarding this outcome. Only one of these studies done by SA Telian et al demonstrated that the use of perioperative antibiotics was associated with a significant reduction in the number of patients experiencing postoperative fever. Another two studies done by CR Cannon and JR Grandis et al. found no association between use of antibiotic and postoperative fever 7 .
16 patients who did not received antibiotic post-operatively and 21 who received antibiotic had either nausea or vomiting. It was statistically insignificant. 81% of the total patients who had nausea or vomiting were female, it indicates that post-operative nausea and vomiting is significantly higher in female. Two studies reported results regarding the incidence of nausea and vomiting. WC Lee et al. and BE Lindenet al. found no significant difference in the incidence of nausea and vomiting between antibiotic treated patients and patients who did not receive antibiotics during the perioperative period. 8 Examination of the tonsillar fossa was done on 1 st , 2nd, 3rd, 5th and 7 th postoperative day. On 1 st postoperative day tonsillar fossa of 3 patients in each groups found unhealthy. On the 5 th day 3 patients from placebo group developed unhealthy tonsillar fossa and on 7 th day it was 5. In the antibiotic group tonsillar fossa of 2 patients were found unhealthy on 7 th postoperative day. 3 patients who received placebo had unhealthy tonsillar fossa on 1 st postoperative day and 3 patients had unhealthy tonsiller fossa on the 5 th postoperative day . 1 patient had developed secondary haemorrhage.
2 (3.8%) patients of placebo group and 1 (1.7%) of antibiotic group had developed reactionary haemorrhage. And one patient from each group developed secondary haemorrhage. While comparing the two groups it was found statistically insignificant. Total reactionary haemorrhage was 2.6% and it was 3.8% and 1.7% in placebo and antibiotic group respectively.
Out of 110 patients a total number of 2(1.8%) 1 in each group had developed secondary hemorrhage. The rate is slightly lower than the published rate of 3-5%. 8 Four studies evaluated for postoperative hemorrhage and reported incidence rates. None reported a significant difference in postoperative bleeding between the antibiotic treated group and untreated group. 3 Cannon reported that the rate of postoperative hemorrhage was same in both groups. Antibiotics did not significantly reduce secondary hemorrhage rates. 7  Mean duration of hospital stay Placebo group was 2.57 (±1.22) days and in antibiotic treated group it was 2.45 (±1.14) days. P value was 0.59 that is statistically not significant.

Discussion:
The results of this study show that postoperative pain in antibiotic treated group significantly reduced from 5 th and 7 rd postoperative day and onwards respectively than those who received placebo. And the patients who received antibiotic had also early return to normal diet in comparison those who did not receive antibiotic, probably due to earlier decrease of pain and odynophagia.
There is no statistically significant difference between the patient groups who received antibiotic and who had not after tonsillectomy in respect of fever, nausea and vomiting, reactionary and secondary haemorrhage and duration of hospital stay