|Year : 2016 | Volume
| Issue : 3 | Page : 515-522
Prophylactic steroids and/or antibiotics to reduce post-tonsillectomy morbidity: a double-blind placebo-controlled trial
Elsayed M Abd Allah Rezk, Adel T Ataallah, Ahmed A Ragab, Ayman A Abd Fattah
Department of ENT, Faculty of Medicine Menoufia University, Shebin, Elkom, Egypt
|Date of Submission||17-Oct-2015|
|Date of Acceptance||21-Feb-2016|
|Date of Web Publication||23-Jan-2017|
Elsayed M Abd Allah Rezk
Block 1, Entrance 2, Speco Building, Elmokatm, Cairo, 5511
Source of Support: None, Conflict of Interest: None
The aim of this study was to evaluate the role of postoperative oral steroids (prednisolone) and/or antibiotic (amoxicillin and clavulanic acid) to reduce post-tonsillectomy (with or without adenoidectomy) morbidity.
Tonsillectomy remains one of the most common surgical procedures performed worldwide. Mortality rates for the operation range from one in 10 000 to one in 35 000, with morbidity rates ranging from 1.5 to 14%. Consequently, antibiotics ± oral steroids are frequently prescribed in an effort to minimize complications such as pain, dehydration, secondary infection of the operative site, and haemorrhage.
Materials and methods
A total of 265 children subjected to tonsillectomy with or without adenoidectomy were randomly allocated into four groups. The patients were blinded to the postoperative medications that they received: group A, two placebo treatments for 5 days (75 patients); group B, postoperative antibiotic and placebo for 5 days (64 patients); group C, postoperative antibiotic and oral steroid for 5 days (61 patients); and group D, postoperative oral steroid and placebo for 5 days (65 patients). The postoperative recovery was assessed by completion of a questionnaire including the following parameters: pain degree, fever, nausea and vomiting, halitosis, pharyngeal bleeding, analgesic requirement, and the day of return to a normal diet.
There were no significant differences between the four groups in terms of nausea and vomiting (P ≥ 0.05), but there was a significant difference between the groups favoring group C in the mean pain score (P = 0.0001), paracetamol consumption (P < 0.0001), halitosis (P = 0.01), postoperative bleeding (P = 0.0007), time taken to return to normal diet (P < 0.0001), and fever on postoperative days from the third day (P = 0.0005), fourth day (P = 0.0001), fifth day (P < 0.0001), sixth day (P < 0.0001), to seventh day (P = 0.0002).
Combined prophylactic oral steroids (prednisolone) and antibiotic (amoxicillin and clavulanic acid) for 5 days after tonsillectomy can reduce the postoperative morbidity.
Keywords: antibiotics, morbidity, oral corticosteroids, post-tonsillectomy
|How to cite this article:|
Abd Allah Rezk EM, Ataallah AT, Ragab AA, Abd Fattah AA. Prophylactic steroids and/or antibiotics to reduce post-tonsillectomy morbidity: a double-blind placebo-controlled trial. Menoufia Med J 2016;29:515-22
|How to cite this URL:|
Abd Allah Rezk EM, Ataallah AT, Ragab AA, Abd Fattah AA. Prophylactic steroids and/or antibiotics to reduce post-tonsillectomy morbidity: a double-blind placebo-controlled trial. Menoufia Med J [serial online] 2016 [cited 2020 Apr 1];29:515-22. Available from: http://www.mmj.eg.net/text.asp?2016/29/3/515/198693
| Introduction|| |
Tonsillectomy has been performed for over 2000 years. Adenoidectomy, a much newer procedure that became increasingly common in the late 1800s, is often carried out along with tonsillectomy. In 2006, ~583 000 outpatient tonsillectomy procedures were performed in children in the USA  . The most common indications for tonsillectomy with or without adenoidectomy are airway obstruction associated with tonsillar or adenotonsillar hypertrophy, recurrent tonsillitis, and adenotonsillitis. Although tonsillectomy is a frequently performed procedure, it is not without significant morbidity. Mortality is a rare occurrence and is usually related to complications from anaesthesia or haemorrhage  .
Short-term morbidity after tonsillectomy, however, is very common. Children of school age undergoing tonsillectomy often miss 1-2 weeks of school or day care, and adults miss considerable time from work. Fever, pain, decreased oral intake, halitosis, dysphagia, and trismus occur commonly. Dehydration and weight loss may occur secondary to decreased oral intake. Less common complications include atlanta-axial subluxation, Grisel's syndrome, velopharyngeal insufficiency, and stenosis  . Early (in the first 24 h) and late (after the first 24 h up to 2-3 weeks after surgery) bleeding may also occur, with an overall rate of significant postoperative haemorrhage of 0.1-3.0%  .
Perioperative use of antibiotics has been shown to be effective in reducing some of the morbidities of adenotonsillectomy, which include postoperative pain, fever, and haemorrhage. Infection of the operation site has been thought to be a major contributor to the above, which otolaryngologists try to prevent using antibiotics  . Antibiotics have been shown to reduce postoperative fever, pain, and general lassitude and increase oral intake  . However, the widespread use of antibiotics is not always benign, as treatment may result in allergic reactions, diarrhea, nausea and vomiting, and increased antimicrobial resistance. Moreover, much of the recent literature on tonsillectomy recommends the use of antibiotics in the perioperative or the postoperative period, and yet few investigators have analysed the actual efficacy in an evidence-based manner  .
Postoperative analgesia will always be required irrespective of any effect of prophylaxis. Nonaspirin, NSAIDs are now recognized not to increase secondary haemorrhage rates, and so are usually the drugs of choice. However, it is not clear as to whether there is an additional role for postoperative steroids. It is now accepted that oral corticosteroids are effective in the management of sore throat in children and in adults, although no trial has yet been reported of their use for post-tonsillectomy pain. The question here must also cover the potential for secondary haemorrhage  .
Hence, the aim of the following double-blind placebo-controlled trial was to evaluate the role of postoperative oral steroids (prednisolone) and/or antibiotics (amoxicillin and clavulanic acid) to reduce post-tonsillectomy (with or without adenoidectomy) morbidities.
| Materials and methods|| |
Our randomized double-blind placebo-controlled prospective trial was approved by the regional ethics committee, and written informed consent was obtained from each child's guardian. The study included 265 patients of both sexes aged 3-18 years scheduled for elective tonsillectomy or adenotonsillectomy for recurrent tonsillitis or obstructive symptoms at the Menoufia University Hospital outpatient ENT and pediatrics clinics, Egypt, and the Ahmed Maher Teaching Hospital outpatient ENT clinic, Cairo, Egypt, from April 2012 to December 2014. Patients were included in the study if they fulfilled one of the following criteria: chronic tonsillitis, recurrent tonsillitis, or tonsillar hypertrophy causing obstructive symptoms.
Patients with a known contraindication to steroid use, previous corticosteroids treatment, medical conditions requiring perioperative antibiotic (recent acute tonsillitis and heart disease), a history of penicillin allergy, enlarged adenoid only, suspected or confirmed tonsillar malignancy, or a history of peritonsillar abscess (severe pain-fibrosis) were excluded from the study.
The children included were randomly allocated into four groups by computer-generated numbers obtained from the GraphPad Software, Inc., La Jolla, CA 92037 USA.
- Group A (placebo group/control group): 75 patients received 5 days of placebo only
- Group B (antibiotic group): 64 patients received 5 days of postoperative oral antibiotic and placebo
- Group C (antibiotic steroid group): 61 patients received 5 days of postoperative oral antibiotic and oral steroid
- Group D (steroid group): 65 patients received 5 days of postoperative oral steroid and placebo for a period of 5 days
- Placebo is an imitation of a specific treatment with the absence of the specific therapeutic constituents, and it is a pharmacologically inert substance (generally control treatments) with appearance, taste, colour, and label similar to that of the study treatment, but without their specific activity; the typical pharmacologic placebo is sugar syrup.
The first dose of all medication will be given 2 h postoperatively. The antibiotic was oral amoxicillin and clavulanic acid (augmentin suspension, weight-adjusted prophylactic dose 25 mg/kg/day amoxicillin divided into two doses every 12 h), and the steroid was oral prednisolone (predsol forte at a dose of 0.5 mg/kg/day divided into two doses every 12 h); placebo was a teaspoon (5 ml) of sugar syrup given every 12 h. Paracetamol syrup at a dose of 15 mg/kg/dose according to patient's request and severity of pain was given as an analgesic to all patients in all groups.
The study design
The study was double blinded: none of the patients, their parents, or the surgeon knew the group of the allocated child; every patient was identified by a code letter, number, and star symbol, such as *A25.The letter refers to the treatment group, the number refers to the patient randomization number, and the star symbol for the bottle type: one for placebo, two for antibiotic, and three for the steroid bottle. None of these codes were known to the patient or the investigator; all patient data and medication bottles had this code till the final data analysis was conducted. All medication bottles had a label carrying the patient's code; all data analyses were performed by a third person who had no knowledge about the group of each patient, and postoperative medications was given by a pharmacist according to the patient's code.
The included patients were subjected to the following evaluations:
Full demographic data, complete history taking, complete otolaryngological anamnesis, general history and examinations by the paediatrician, complete otolaryngological examinations, and laboratory investigations including complete blood count and bleeding profile, which should be within normal ranges.
The operative procedure was uniform among surgeons. The anaesthetic was standardized when possible. The surgical technique was cold-steel dissection tonsillectomy, with ligature for haemostasis, traditionally; the adenoid pad was removed by curettage with a postnasal pack for haemostasis in all groups.
Patients were typically discharged on the same day, unless they have contraindications such as persistent emesis or failure to take liquids by mouth. Children were considered to meet the discharge criteria when they were fully awake, cooperated, stable, free of tonsillar bleeding, and able to ingest clear fluid or soft diet. Postoperative instructions were uniform for all patients and included advice that the child could resume a normal diet as tolerated.
Before being discharged home, a dairy was given to the parents of the operated child. This charted the daily postoperative course for the 7 days immediately after discharge. The parents were asked to note the following in their child: incidence of fever, presence of nausea and vomiting, degree of throat pain, presence of halitosis, presence of pharyngeal bleeding and, if so, its severity and timing, daily analgesic dose required, and time required to return to normal diet.
Entry into the diary was started on the operative day and continued for 7 days. We called the parents at intervals during the postoperative period to encourage completion and return of the diary.
Definitions and estimation of the tested parameters
0In patients aged 12 years and older, a simple linear analog pain scale from 0 = no pain to 10 = most severe using the pain intensity scale was used ([Figure 1]), whereas for patients aged 3 to 11 years, the Oucher Faces Scale was applied ([Figure 2]). This consists of a series of six photographs depicting a child in various degrees of distress corresponding to a numeric scale of 0 to 10. Each child's comprehension and proficiency at using this scale was examined at the preadmission clinic. No child was excluded from this study because of an inability to use the pain scale.
Fever was defined by a temperature reading that was more than 37.2°C taken by a thermometer in the axilla.
Nausea is a nonobservable phenomenon of an unpleasant sensation experienced in the back of the throat and the epigastrium that may or may not culminate in vomiting; it is synonymously described as feeling 'sick at stomach'. It is usually determined through a self-report, but may also have some objective elements, depending on the intensity.
Vomiting is the forceful expulsion of the contents of the stomach through the oral or nasal cavity. Both the occurrence and the frequency of vomiting may be objectively measured.
Oral malodor or bad breath.
Postoperative bleeding was defined as a bleeding that prolonged the patient's hospital stay, required blood transfusion, or return to the operating theatre. In case of 'secondary' hemorrhage that requires readmission to hospital was respected and considered within the postoperative bleeding.
The time required to return to normal diet was assessed by the duration of time taken for the patient to start taking his/her usual diet after surgery. A progressive assessment was performed with regard to the diet consistency that the patients tolerating, with the options of 'nil', 'liquid', 'semisolid', and 'usual'.
Patients were invited to join the study during their attendance at the pre- admission visit as The patients were routinely admitted to the ward on the day of surgery.
The data were processed on an IBM-PC compatible computer using SPSS version 16 (SPSS Inc., Chicago, Illinois, USA).Continuous parametric variables were presented as means ± SD, whereas categorical variables were presented as n (%). In the statistical analyses, compatibility with standard distribution was evaluated using the Shapiro-Wilk normality test. The χ2 -test was used for qualitative variables. The difference between two groups was determined by Student's t-test for parametric continuous variables and the Mann--Whitney U-test for nonparametric variables. For more than two groups, the one-way analysis of variance test was used for parametric data and the Kruskal-Wallis test was applied to determine differences in nonparametric variables. The least significant difference test (for parametric variables) and Tukey's honest significant difference test (for nonparametric variables) were applied for comparisons between individual groups when appropriate. A two-sided P value less than 0.05 was considered significant results and the P value less than 0.001 was for highly significant results. The post-hoc power of the study was 83.3%.
| Results|| |
The flowchart of the study is illustrated in [Figure 3]. About 61 (23%) out of the 265 patients initially recruited into this study dropped out of the study, 61 patients were excluded due to various reasons, including 25 patients in the placebo group who were given postoperative antibiotic either by themselves or by another doctor, 10 patients in antibiotic group who were given either parenteral antibiotic or antibiotic other than amoxicillin and clavulanic acid, 14 patients who refused to complete the study, and 12 patients who failed to return the dairy of patient's record. The remaining 204 patients, including 50 in the placebo group, 54 in the antibiotic group, 52 in the antibiotic and steroid group, and 48 in the steroid group, were analysed.
We found that the four groups did not differ significantly with respect to age and sex ([Table 1]).
A significant difference was found between groups with regards to halitosis (P = 0.01*).There were four secondary haemorrhages in groups A (8%) and D (8.3%) and none in groups B and C (0%) ([Table 2]). These cases were readmitted to the hospital and were treated. Regarding nausea and vomiting, there was less nausea, vomiting, or both in the steroid and steroid and antibiotic groups on days 4-7, but the difference was not significant (P = 0.63) ([Table 2]).
|Table 2 Comparison between all groups regarding postoperative halitosis, bleeding, and nausea and vomiting |
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There were significant differences between the groups in the mean pain score, paracetamol consumption (mg/kg/day), fever, halitosis, postoperative bleeding, and time taken to return to normal diet: the morbidity was the least in group C (antibiotic steroid group), followed by group B (antibiotic group), then group D (steroid group), and then group A (placebo group) ([Table 3]).
|Table 3 Comparison between the four groups regarding pain, paracetamol consumption, and time to return to normal diet |
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Postoperative fever from the third day to the seventh day differed significantly among groups. The differences were marked between groups A and D on the one hand and groups B and C on the other ([Table 4]).
|Table 4 Comparison between the four groups regarding postoperative fever |
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| Discussion|| |
Tonsillectomy is still one of the most common operations performed in the paediatric age group and is associated with significant morbidity. Tonsillectomy remains a common surgical procedure with a substantial risk for complications, the most serious of which is postoperative haemorrhage.  Lee et al.  report 90.4% of their patients experiencing distress up to 5 days postoperatively and 36.8% having physical or behavioral changes after discharge from hospital. The first week after tonsillectomy can be extremely difficult for both the child and the parents, and therefore, in seeking to provide excellent care for our patients, we were interested in minimizing the morbidity after such a procedure  .
Data obtained from this study showed a significant improvement in recovery in the groups taking antibiotics (group B) or a combination of antibiotics with oral steroids (group C) because it showed a lower pain score, paracetamol consumption, and halitosis, and a quicker resumption of normal diet compared with other groups. Cook et al.  showed that inadequate food consumption after tonsillectomy is significantly associated with an increased incidence of secondary haemorrhage. It seem to be confirmed by the presence of four patients with secondary haemorrhages in each groups A (8%) and D (8.3%) in this study. There were significant differences from the third day to the seventh day in the incidence of fever among the groups. The differences were marked between groups A (placebo group) and D (oral steroid group) on the one hand and groups B (antibiotic group) and C (antibiotic steroid group) on the other; this seems to be due to infection in the tonsillar fossa. However, oral steroid showed added benefit to antibiotic when used together with regard to the mean pain score, paracetamol consumption, time to resume a normal diet, and no increase in the risk of haemorrhage.
One of the limitations of the present study was the interaction of many surgeons who conducted the surgery: although the same surgical technique of cold steer tonsillectomy was used, there may have been small difference between surgeon with regard to surgical skills and efficiency.
Investigators have analysed the use of antibiotics to reduce post-tonsillectomy morbidity, with no clear consensus. Data from randomized studies have demonstrated conflicting results, with some showing a clinical benefit, and others failing to show any benefit. The following is a brief synopsis of articles that investigate antibiotics' effects on the post-tonsillectomy morbidity.
Some previous studies showed a clinical benefit from the use of postoperative antibiotics. Telian et al.  reported that ampicillin/amoxicillin administered to children during the first week after tonsillectomy minimized postoperative morbidity (postoperative fever, halitosis, anorexia, pain, and lassitude). Grandis et al.  stated that patients who received antibiotics experienced significantly less halitosis, and were able to tolerate a regular diet sooner and resumed their normal activities earlier than the control group. Later, Colreavy et al.  found that there was considerably less morbidity in children who received postoperative antibiotics compared with those who did not, as judged by the amount of analgesic consumed (P = 0.379), time to resumption of normal diet (P = 0.0072), and pain analogue scores (P = 0.0006). More recently, Dhiwakar et al.  showed that antibiotics significantly reduced the number of subjects manifesting fever and the duration of halitosis and marginally reduced the time taken to resume normal activity.
In contrast, other researchers failed to show any benefit from antibiotic usage.
Lee et al.  in 1996 showed that there was no significant reduction in any of the morbidity measures in patients treated with antibiotics. Also, Mann et al.  in 1999 showed that there is no significant difference between the antibiotic-treated group and the untreated control group in terms of halitosis, otalgia, fever, activity level, and diet with respect to pharyngeal pain. Al-kindy  showed that postoperative antibiotic played no role in pain control, postoperative fever, secondary haemorrhage, or reduction in hospital stay. Later, O'Reilly et al.  assessed the effect of perioperative amoxicillin on the complications of pain and secondary haemorrhage by a randomized, double-blind, placebo-controlled, prospective trial and concluded that no significant differences were demonstrated between the active and the placebo groups in any of these measures. In 2005, Burkart and Steward  showed that the results of a systematic meta-analysis of seven randomized controlled trials of postoperative oral antibiotics in patients undergoing tonsillectomy or adenotonsillectomy suggest that postoperative oral antibiotics do not significantly reduce post-tonsillectomy pain, but result in an earlier return to normal activity and diet by 1 day.
The use of steroids in the form of perioperative single-dose injections of dexamethasone, intratonsillar injections, and oral preparations have been studied in the past. The basis for their usefulness lies in their effect on various cellular factors involved in the inflammatory response. Glucocorticoids cause inhibition of the overall inflammatory response by blocking factors such as bradykinin, prostaglandin, and leukotrienes, which can cause tissue oedema and nerve irritation. This potentially results in a reduction in the degree of inflammation and its accompanying signs and symptoms. It has therefore been proposed that steroids, which are safe in the short term, may be of use in recovery from tonsillectomy  .
Oral steroids such as prednisolone are easier to administer and can be given to tonsillectomy patients as a postoperative course  .
Macassey et al.  compared a 5-day course of an oral prednisolone group and a placebo group in 215 paediatric patients who had undergone tonsillectomy to assess the effect of the steroid on postoperative pain, nausea, vomiting, and sleep quality. They reported no significant differences between the groups, and concluded that there is no evidence for any benefit from the postoperative administration of prednisolone in paediatric patients recovering from tonsillectomy.
In contrast, in 1972, Papangelou  first proposed the use of an oral steroid for recovery from tonsillectomy. He suggested that steroids improve rehabilitation and help reduce pain up to the third postoperative day. Park et al.  showed that prednisolone had significant benefits in pain control and recovery to normal life in paediatric patients and reduced morbidities in adult patients after tonsillectomy. It contributed to better wound healing irrespective of indications for tonsillectomy. These findings are probably due to the inhibition of inflammatory reactions by the steroid, which would have facilitated healing at the surgical site. Oral prednisolone may therefore be of considerable benefit to patients and help their recovery after a tonsillectomy.
Hence, the results of the previous two studies confirm our results that oral steroids combined with antibiotics have more benefits, and can lead to decreased pain and consumption of analgesics, and a quicker return to normal diet, but without any effect on halitosis and bleeding.
| Conclusion|| |
Combined use of prophylactic oral steroids (prednisolone) and antibiotic (amoxicillin and clavulanic acid) for 5 days after tonsillectomy can reduces postoperative morbidities.
Authors' contributions: Concepts, design, and definition of intellectual content carried out by Adel Tharwat Ataallah, MD, and Ahmed Abd Elmoniem Ragab, MD, PhD. Manuscript preparation, manuscript editing, and manuscript review carried out by Ahmed Abd Elmoniem Ragab, MD, and Ayman Ali Abd El Fattah, MD. Literature search carried out by Ayman Ali Abd El Fattah, MD. Clinical studies and data acquisition carried out by Elsayed Mohamed Abd Allah Rezk, MBBCh.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]