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Effect of oral prednisolone on pain after tonsillectomy with sutures: A randomized clinical trial
Amin Shayan, Nezammedin Berjis, Sayed Mostafa Hashemi
Department of Otolaryngology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran
| Date of Submission | 03-Dec-2022 |
| Date of Acceptance | 21-Jun-2023 |
| Date of Web Publication | 31-Jul-2023 |
Correspondence Address:
Prof. Nezammedin Berjis
Department of Otolaryngology, School of Medicine, Isfahan University of Medical Sciences, Hezar Jerib St, Isfahan - 81745-33871
Iran
 Source of Support: None, Conflict of Interest: None  | Check |
DOI: 10.4103/abr.abr_410_22
Background: Tonsillectomy, one of the most common otolaryngology surgeries, often results in postoperative complications such as pain and bleeding. Currently, there is no consensus on postoperative pain management. This study aimed to determine the efficacy of oral prednisolone on postoperative pain after tonsillectomy with sutures.
Materials and Methods: This pilot, double-blind, randomized clinical trial was conducted at two tertiary care centers affiliated with Isfahan University of Medical Sciences. Patients who underwent tonsillectomy with sutures were included. Participants were randomly divided into experimental and control groups. In the experimental group, patients received oral prednisolone in addition to acetaminophen; in the control group, patients received acetaminophen and a placebo. Post-operative pain was evaluated by a visual analog scale daily for ten days.
Results: Initially, 60 patients were enrolled in the study; however, four were excluded due to non-attendance at follow-up visits. The groups were similar in terms of age and sex (both P values >0.05). In the study, postoperative pain from 1st day to the 10th day was lower in the experimental group than in the control group (P value <0.05).
Conclusion: Numerous studies have been conducted on the effect of intravenous corticosteroids on this pain. However, there is no consensus on the analgesic role of oral corticosteroids for post-tonsillectomy pain. The present study showed that oral prednisolone is effective on post-operative pain compared to a placebo.
Keywords: Post-operative pain, prednisolone, tonsillectomy
How to cite this article:
Shayan A, Berjis N, Hashemi SM. Effect of oral prednisolone on pain after tonsillectomy with sutures: A randomized clinical trial. Adv Biomed Res 2023;12:202 |
How to cite this URL:
Shayan A, Berjis N, Hashemi SM. Effect of oral prednisolone on pain after tonsillectomy with sutures: A randomized clinical trial. Adv Biomed Res [serial online] 2023 [cited 2023 Sep 26];12:202. Available from: https://www.advbiores.net/text.asp?2023/12/1/202/382554 |
| Introduction | |  |
Tonsillectomy is one of the most common otolaryngology surgeries, with over 500,000 procedures performed annually in the United States.[1] Although the rate of tonsillectomy decreases with age, postoperative complications such as pain and bleeding become more pronounced. These complications delay the onset of oral feeding, leading to longer hospital stays and increased healthcare costs.
Most studies on post-tonsillectomy pain management have been conducted in pediatric populations due to the higher incidence of surgery in children. Either oral or intravenous, corticosteroids decrease post-tonsillectomy pain in children.[2],[3] However, there is no consensus on the use of corticosteroids for post-tonsillectomy pain in adults. Non-opioid analgesics are currently the first line of treatment for pain management in these patients, as opioids are associated with harmful side effects, such as nausea and sedation, which can delay recovery.[4] Among non-opioid analgesics, acetaminophen is widely accepted as the first choice; however, its efficacy is often insufficient to relieve pain in many patients, making pain management challenging after tonsillectomy in adults.[5]
Recently, corticosteroids have been added to postoperative pain management due to their anti-inflammatory effect.[6] While intravenous corticosteroids such as dexamethasone have been widely evaluated in studies;[3],[7],[8] there is no agreement on the use of oral corticosteroids such as oral prednisolone, as the results of studies are inconsistent.[9],[10] Therefore, the present study aimed to investigate the effect of oral prednisolone in addition to acetaminophen compared to oral acetaminophen alone on pain management in adults after tonsillectomy with sutures.
| Materials and Methods | | |
This pilot, double-blind, randomized controlled clinical trial aimed to evaluate the effect of oral prednisolone with oral acetaminophen compared to oral acetaminophen alone on pain score in adult patients undergoing elective tonsillectomy with suture. The study protocol was reviewed and approved by the ethical committee of the Isfahan University of Medical Sciences (IR.MUI.MED.REC.1399.715) and informed consent was obtained from all patients. Inclusion criteria were patients aged between 18 and 65 years undergoing elective bilateral tonsillectomy with sutures for chronic tonsillitis, tonsillolith, snoring, and sleep apnea. The patients were chosen among candidates in Alzahra and Kashani hospitals, affiliated hospitals of Isfahan University of Medical Sciences, between November 2020 and September 2021. Patients with hypertension, glaucoma, or diabetes were excluded from the study. Randomization was done on the day of surgery using random codes given by an otolaryngology resident who was blind to the codes. The otolaryngology resident gave each patient a random number from 101 to 160.
Patients with codes between 101 and 130 were assigned to the intervention group, and those with codes between 131 to 160 were assigned to the control group. The principal investigator was the only person who knew the mentioned protocol. All patients underwent bilateral tonsillectomy with sutures by one surgeon, and no cauterization, bipolar and monopolar, was used. After surgery, each patient received him/her drugs by showing the code to a pharmacist, who was blind to codes and only gave the sealed drug pocket assigned to each code, containing a prednisolone tab or placebo, to the patient. The placebo tab was designed precisely as the prednisolone tab and contained starch. Control group patients receive as many placebo tabs as if it was prednisolone. The experimental group included 28 patients receiving a dose of 0.5 mg/kg of prednisolone tab daily divided into 4 doses every 6 hours and 500 mg of acetaminophen every 6 hours. The control group included 28 patients receiving placebo tabs and a dose of 500 mg acetaminophen every 6 hours.
Both groups continued treatments for seven days at home and were given a checklist including demographic data and ten visual analog scales (VAS) for pain assessment for ten days. Patients were educated to fulfill the checklist in the morning after rinsing the mouth and delivering it to the otolaryngology resident 10 days later at a follow-up visit. To ensure that all the patients understood the mentioned process before fulfilling the checklist, they were observed during mouth rinsing and filling the checklist on the first post-operation day.
Data were analyzed using IBM SPSS (IBM Crop. 2019. IBM SPSS Statistics for Windows, version 26.0. NY, EUA). The analyzer knew that each code contributed to the intervention/control group. Descriptive statistics were presented with arithmetic mean values and standard deviation for quantitative variables, the number of patients, and their percentage for qualitative variables. Since the observations violated the null hypothesis of normality distribution, the non-parametric tests were conducted to evaluate the differences between groups. Hence, the differences between the two independent groups were compared via the Mann-Whitney U test. Also, the differences among more than two independent groups were investigated by the Kruskal-Wallis H test. Moreover, the Pearson Chi-square test was used for the test of independence of two categorized variables. A two-sided P value of (≤0.05) was considered statistically significant in all analyses. Differences in VAS scores higher than 0.9 was considered clinically significant.
| Results | | |
Out of the 60 patients initially enrolled in the study, four refused to attend follow-up visits, leaving 28 patients in both the experimental and control groups. Analyses showed no significant differences between the two groups in terms of age and sex (P value = 0.886 and P value = 0.593, respectively) [Table 1]. | Table 1: Descriptive statistics of demographic data of experimental and control groups
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The study found that pain was less in the experimental group compared to the control group from the first day, and this difference was statistically significant (P value = 0.015) but not clinically significant [Table 2]. This trend continued throughout all ten days, with both clinical and statistical significance from 2nd day (P value < 0.001). Additionally, the mean VAS after tonsillectomy over ten days was statistically lower in the experimental group than in the control group (P value < 0.001). | Table 2: Comparison of postoperative pain in experimental and control groups
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Analysis revealed no difference between males and females in each group; however, significant differences were found between males in the two groups and females in the two groups [Figure 1]. Comparison of postoperative pain in age groups showed no difference between experimental and control groups, although significant differences were revealed in all age groups between the two groups [Figure 2]. | Figure 1: (a) Comparing visual analog scale mean values between males and females for two groups (b) Comparing visual analog scale mean values between groups of study for males and females. (ns = non-significant; ***: P value < 0.001)
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 | Figure 2: (a) Comparing visual analog scale mean values among different age categories for two groups, (b) Comparing visual analog scale mean values between two groups for each category of the age of patients. (ns = non-significant; ***: P value < 0.001)
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| Discussion | | |
Postoperative pain management after tonsillectomy in adults has been a challenging issue for both patients and physicians, and the effects of systemic corticosteroids on this issue have been studied for years. In this prospective, randomized, double-blind study, we demonstrate that prednisolone, in addition to acetaminophen, reduces post-operative pain more effectively than acetaminophen alone after tonsillectomy with sutures in adults. Previous studies have shown that corticosteroids can reduce postoperative pain after tonsillectomy in both children and adults.[11],[12],[13] However, according to our literature review, one study found no evidence of pain relief after using corticosteroids in adults.[14] The analgesic effect of corticosteroids may be due to their anti-inflammatory function.[6] Most studies have evaluated the impact of intravenous dexamethasone as a corticosteroid on postoperative pain in the first one or two days after surgery, as intravenous dexamethasone is typically used in in-patient settings, which can increase healthcare costs.
Our study, similar to most studies on dexamethasone, demonstrated that prednisolone is effective in reducing postoperative pain over a 10-day evaluation period. Pain relief on the first postoperative day was less than in studies on dexamethasone, but pain relief on subsequent days was comparable. Additionally, oral prednisolone led to the earlier discharge, resulting in lower healthcare costs and higher patient satisfaction. Furthermore, a short-term regimen of prednisolone at a dose of 0.5 mg/kg/day has been shown to not require tapering, thereby reducing the risk of withdrawal symptoms and minimizing potential adverse effects. Moreover, studies have reported no significant harmful events in patients receiving this dose of prednisolone, suggesting its safety and tolerability.[15]
However, further studies are recommended as our study has some limitations. One of the limitations is the relatively low number of patients in each group. Additionally, the visual analog scale, which is a subjective tool to assess pain, could introduce bias when comparing two parallel groups. Therefore, further studies should be conducted with a larger population and in a multi-centric study using an objective tool to assess pain.
| Conclusion | | |
Post-operative pain after adult tonsillectomy is one of the most common and bothersome symptoms experienced by patients. To date, many studies have investigated the effect of intravenous corticosteroids on this pain; however, there has been no study on the analgesic effect of oral corticosteroids. The present study showed that oral prednisolone, when used in combination with acetaminophen, is more effective in reducing postoperative pain compared to acetaminophen alone.
Financial support and sponsorship
The funding was received from Isfahan University of Medical Sciences. No: 399607
Conflicts of interest
There are no conflicts of interest.
| References | | |
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[Figure 1], [Figure 2]
[Table 1], [Table 2]
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