The Effect of Systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Vs Intraoperative Infiltration of Steroids in Tonsillar Bed Following Tonsillectomy on Post Tonsillectomy Pain: A Prospective Randomized Controlled Study.
Phase: NA
Conditions: Tonsillitis Chronic, Tonsillitis Recurrent, OSA - Obstructive Sleep Apnea
Sponsor: Ain Shams University

 
 
 
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PROTOCOL OF A THESIS FOR PARTIAL FULFILLMENT OF MASTER 
DEGREE IN OTORHINOLARYNGOLOGY 
 
Title of the Protocol:  
 
The effect of systemic nonsteroidal anti-inflammatory drugs (NSAIDs) Vs 
intraoperative infiltration of steroids in tonsillar bed following tonsillectomy on 
post tonsillectomy pain: A prospective randomized controlled study. 
 
Approval date :19/1/2025 
 
Postgraduate Student:  Abdurrahman Samir Mohamed Mohamed Harby  
Degree: 
                    M.B.B.Ch, Ain Shams University (2021) 
Resident at ENT department ,Ain Shams University 
Hospitals   
 
Director:   
 
Prof. Dr. Samia Ahmed Mahmoud Fawaz 
Academic Position:  
Professor 
Department:  
Otorhinolaryngology 
 
 
Co-Director:  
 
Dr. Peter MiladMikhail  
Academic Position:  
Assistant Professor 
Department:  
 
Otorhinolaryngology  
 
 
 
Co-Director:  
 
Dr. Ahmed Mohamed Kamel  
Academic Position:  
Lecturer 
Department:  
 
Otorhinolaryngology 
 
 
Co-Director:  
 
Dr. Omar Mostafa Yosef 
Academic Position:  
Lecturer 
Department:  
 
Otorhinolaryngology 
 
 
Faculty of Medicine 
Ain Shams University 
2024 
 

 
 
 
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What is already known on this subject?  
What does this study add? 
Tonsillectomy operations are frequently performed surgical procedures among 
children. The removal of the tonsils and the adenoids is considered to be relatively safe with 
no known long-term immunological side effects. Pain is the number one perioperative 
concern and post-operative complaint in most patients, causing many health morbidities 
especially in children. Post-tonsillectomy pain is one of the most frequent morbidities of 
tonsillectomy surgery. This randomised controlled clinical trial study will compare the 
efficacy of adding paracetamol tosystemic non-steroidal anti-inflammatory drugs (NSAIDs) 
versus adding steroidsas local infiltration to paracetamol on post tonsillectomy pain control. 
 
1. INTRODUCTION/ REVIEW 
Tonsillectomy is one of the most commonly performed surgeries in the world, 
particularly in children. The palatine tonsils are encapsulated within the space formed 
between the anterior and posterior pharyngeal pillars known as the tonsillar fossa (Cohen& 
Sommer, 2016). 
 Tonsillectomy consists of the complete removal of the tonsil tissue by dissection 
along the capsule, lifting the tonsil off the adjacent muscular wall. In children, this 
procedure is often performed in concert with adenoidectomy for various indications 
including recurrent tonsillitis. Less frequent indications for tonsillectomy include  sleep 
disordered breathing or obstructive sleep apnea syndrome (OSAS), treatment of periodic 
fevers with aphthous stomatitis, pharyngitis and adenitis,treatment/biopsy for tonsillar 
malignancy (Baugh et al., 2011). 
 Although tonsillectomy is one of the most common surgical methods performed 
worldwide, postoperative morbidity remains a significant clinical problem despite advances 
in anaesthetic and surgical techniques (Ali, 2004).It is important to better understand the 
pathophysiology of post tonsillectomy pain. First, pain can ensue simply from the 
positioning of the patient, including the placement of a mouth retractor (e.g., Boyle–Davis 
mouth gag). This can cause pressure and venous congestion of the tongue and postoperative 
swelling and pain, as well as stretching of the temporomandibular joint. Patients frequently 
also complain of ear discomfort, presumably referred otalgia, mainly via the 
glossopharyngeal nerve. As well, removal of the tonsil triggers inflammatory cascades that 
facilitate healing, but also leaves an open wound in the pharynx with exposed nerve fibers 
and damaged muscle fibers (Cohen & Sommer, 2016). 
This combination of factors creates a postoperative wound that is vulnerable to 
mechanical trauma generated during swallowing. The tonsillectomy wound also displays 

 
 
 
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evidence of infection and inflammation by generation of a thick fibrin layer (Sutters 
&Isaacson, 2014), that increases in size during the first 3–4 days postoperatively, and 
begins to shed at about 7 days, usually allowing the bed to remucosalize by the end of 2 
weeks (Isaacson, 2012). In accordance with this healing process, post-tonsillectomy pain 
can manifest a biphasic pattern, with peaks at 3 and 7 days postoperatively, but may persist 
past 2–3 weeks following surgery (Stewart et al., 2012). 
Post-tonsillectomy pain can be severe enough to hinder the return to normal activities, 
and impair swallowing leading to an increased risk of dehydration, secondary infection and 
bleeding. Pain leads to more need for analgesic medication, higher risk of complication, 
increase days of hospitalization and greater number of missed school and work 
days(Warnock &Lander, 1998;Robinson &Purdie, 2000). 
There are many different methods of tonsillectomy such as cold dissection (CD) or 
hot dissection as in monopolar–bipolar dissection (MBD) and coblation dissection (CBD). 
(Álvarez et al., 2017). Based on the methods of tissue dissection and hemostasis (control of 
bleeding) either, different techniques are used in tonsillectomy such as hot-hot, cold-hot, and 
cold-cold techniques. The choice of a specific technique in tonsillectomy can significantly 
influence postoperative outcomes such as pain, bleeding, and recovery time.(Abdel-Aziz et 
al., 2023) 
 The "hot-hot" technique, which uses electrocautery for both dissection and 
hemostasis, is effective in controlling bleeding but may cause increased thermal damage to 
surrounding tissues, leading to more postoperative pain(Verma et al., 2017). The "cold-hot" 
technique combines cold dissection with hot coagulation, offering a balance of tissue 
preservation with efficient bleeding control. In contrast, the "cold-cold" method, utilizing 
scalpel or scissors for dissection and manual hemostasis, results in less thermal injury and 
may reduce pain, though it may require more careful bleeding management(Stavroulaki et 
al.,2007). Studies have shown that hot techniques have shorter operative time and less 
intraoperative blood loss, while cold dissection technique has less postoperative pain and 
less postoperative complications especially secondary haemorrhage, with more rapid wound 
healing.(Abdel-Aziz et al., 2023). 
Intraoperative steroids are frequently used to prevent postoperative nausea and 
vomiting, and have been used following tonsillectomy (Steward, 2011). Some studies have 
also looked at the role of steroids in pain control and some studies have shown improved 
analgesia with the use of oral steroids postoperatively (Park, 2015). However, there has also 
been controversy surrounding the use of systemic steroids and their possible association 
with bleeding (Hermans, 2012). 
Systemic anti-inflammatory medications, such as nonsteroidal anti-inflammatory drugs 

 
 
 
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(NSAIDs) (e.g., ibuprofen) are well known to be potent analgesics and rival opioids in their 
capacity to control pain, while decreasing the risk of other operative complications such as 
nausea and vomiting. NSAIDs act by inhibiting cyclooxygenase enzymes that mediate 
inflammation and pain. This also results in inhibition of thromboxane, an important 
component in platelet aggregation, potentially resulting in an increased risk of bleeding. 
Consequently, many surgeons are reluctant to use NSAIDs to treat pain in their 
postoperative patients.(Cohen & Sommer, 2016). 
Also known as paracetamol, acetaminophen is a commonly used analgesic and antipyretic. 
Acetaminophen has been shown to be very safe for use in children and generally causes 
fewer side effects than NSAIDs. It is commonly used as a first line of treatment for surgical 
pain, and has been demonstrated to be an effective analgesic for post-tonsillectomy pain. 
However, when used alone, acetaminophen may be insufficient following tonsillectomy, and 
is therefore often used in combination with an NSAID or opioid to obtain adequate pain 
control (Cohen & Sommer, 2016). 
In order to reduce post-tonsillectomy pain, a number of strategies have been 
developed by anaesthetic and surgical staff including the use of corticosteroids. The use of 
local agents, either by topical application into the tonsillar fossa, or by infiltration either 
before or after tonsillectomy has been studied as a method of reducing post-tonsillectomy 
pain. The rationale behind the use of local agents with analgesic or anaesthetic action in the 
peri-operative period relates not only to its ability to block peripheral nociceptor 
transmission after tissue damage but also in preventing sensitization of the central nervous 
system(Grainger, 2008). 
Dexamethasone, a powerful synthetic steroid, is well-known as an effective 
antiemetic. Because of its anti-inflammatory andanti-edematous effects, the drug plays a 
primary role in pain therapy. Dexamethasone is preferred because of its absolute 
glucocorticoid and long-term effect of 36–72 hours. Short-term application, even in high 
doses, is not associated with severe side-effects, and the overall costs are low. 
Dexamethasone can be used in local infiltration to manage pain and inflammation during or 
after surgery. (Egeli & Akkaya, 1997; Ali Maeed, 2004).  
 
2.AIM/OBJECTIVES 
The aim of this study is to compare the efficacy of adding paracetamol to 
systemicnon-steroidal anti-inflammatory drugs (NSAIDs) versusadding dexamethasone as 
local infiltrationto paracetamol on post tonsillectomy pain control. 
 
 

 
 
 
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3.METHODOLOGY:   
Patients and Methods/ Subjects and Methods/ Material and Methods  
Type of Study 
 A Prospective Randomized Controlled study. 
 
Study Setting   
 The 
study 
will 
be 
conducted 
at 
Ain 
Shams 
University 
hospital, 
OtolaryngologyDepartment. 
 
Study Period  
6 months from approval of the protocol. 
 
Study Population  
Participants will be recruited from outpatient ENT clinic,and ENT department inpatients. 
Inclusion Criteria: 
1- Age: Between 4-10 years. 
2- Indications of tonsillectomy such as: 
a) Recurrent acute attacks at least 7 episodes in the past year or at least 5 episodes per year for 2 
years or at least 3 episodes per year for 3 years. 
b) Chronic tonsillitis and hypertrophy of tonsils causing sleep apnea, difficulty in deglutition, 
interference in speech. 
3- Tonsillectomy by cold dissection only. 
4- American Society of Anesthesiologists (ASA) classification 1,2 (Normal Health, Mild 
systematic disease). 
 
 
Exclusion Criteria: 
1- Patients with age less than 4 and more than 10 years. 
2- Indications of tonsillectomy other than chronic tonsillitis such as lymphoma.  
3- Patients on chronic steroid therapy 
4- Hemoglobin level less than 10 gm/dL 
5- Presence of acute infection in the upper respiratory tract, acute tonsillitis 

 
 
 
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6- American Society of Anesthesiologists (ASA) classification ASA 3,4 (Severe systematic 
disease such as uncontrolled Diabetes, cardiac disease, liver or kidney disease, life 
threating medical conditions) 
7- Regular use of analgesics within a week of surgery. 
Sampling Method 
The results were basedon Neupan et al. 2016, with the mean VAS on the fifth day with 
steroid infiltration 6.6 ± 6 while in the control group 13 ± 11. alpha error 5%, power of study 
80%. The required sample size is 75 patients, 25 patients in each group. The program for 
sample size calculation is STATA 10. 
Sample Size(study design) 
The required sample size is 75 patients, will be subdivided randomly by computer-based 
program into 3 groups each consists of 25 patients. 
1- First group: will receive local infiltration ofsteroids (dexamethasone) in tonsillar bed 
and paracetamol. 
2- Second group: will receive systemic nonsteroidal anti-inflammatory drugs in the 
analgesic and anti-inflammatory dosage and paracetamol. 
3- Third group: control group will receive NSAIDs, steroids and paracetamol as standard 
post tonsillectomy medications in our department. 
Based on the results of Neupan et al. 2016, with the mean VAS on the fifth day with steroid 
infiltration 6.6 ± 6 while in the control group 13 ± 11. alpha error 5%, power of study 80%, 
the required sample size is 75 patients 25 patients in each group. The program for sample size 
calculation is STATA 10. 
Ethical considerations: The approval of the Scientific Research Ethics Committee at the 
Faculty of Medicine, Ain Shams University will be obtained before starting work on the 
study. 
Study medications 
All the study medications are FDA approved and typically prescribed and used as post 
tonsillectomy surgery medications and the dosage will be adjusted according to the body 
weight of the patient. 
1- Steroids as Dexamethasone will be injected by local infiltration method.0.1 to 0.5 
mg/kg, with a typical maximum dose of 4 to 10 mg. The dosage ranges from 0.5 to 5 
mg per site. 
2- Systemic nonsteroidal anti-inflammatory drugs (NSAIDs) namely Ibuprofen in the 
analgesic and anti-inflammatory dose 10 mg/kg maximum 40 mg/kg/day. 
3- Paracetamol will be used according to the weight of patient as 15 mg/kg per dose 
maximum 1 g per dose, and 4 g per day.  
Study Procedures 
All patients will undergo tonsillectomy by cold dissection under GA. The intervention will be 
done to the first group (25 patients) by the study investigator. Following tonsillectomy, 

 
 
 
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peritonsillar infiltration will be done.The investigator will infiltrate the study medications 
superficially into the peritonsillar fossae using the aspiration injection technique at the upper 
pole, lower pole, and midway between the two previous injection points at tonsillar bed in 
subcapsular plane (3–5 ml/tonsil) using a straight 23-G/25-G needle. Patients will be 
observed in the post anesthesia care unit (PACU) for 30 min, at least, before transference to 
the ward. Patients will be instructed how to use a 0–10 VAS (0: no pain–10: worst pain) 
(Figure 1). 
Primary outcome 
The primary endpoints that will be used is resting pain scores at 6, 24h and five days 
post-operatively. Where pain score will be measured at multiple points during the outcome 
intervals, the pain scores at the time closest to six and 24h will be used. 
 
Figure 1: Wong-Baker FACES (VAS Score) 
Secondary outcomes 
1- The percentage of the patients in group 1 and 2 that will need extra analgesia  
2- Patient satisfaction and return to normal activity. 
3- Adverse effects noticed such as nausea, vomiting, infection and post tonsillectomy 
bleeding. 
 
 
Statistical analysis 
The data will be analysed using intent-to-treat analysis to ensure unbiased comparisons 

 
 
 
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between treatment groups. Numerical data will be presented as means and standard 
deviations, and the difference between the two groups will be tested using appropriate tests. 
Categorical data will be presented as frequencies and percentages, and the Chi-square test 
will be used for comparisons between groups when appropriate. A p-value < 0.05 will be 
considered statistically significant. 
 
4. ETHICAL CONSIDERATIONS 
This study will start after the approval of the" Research Ethics Committee" of 
Faculty of Medicine, Ain Shams University and an informed consent will be obtained 
from the participants or his/her caregiver, after explaining the study purpose and methods 
to the subjects. 
 
 
5. REFERENCES 
1- Abdel-Aziz, M., Atef, A., Sabry, O. A., et al. (2023). Different tonsillectomy techniques 
in Egypt: Advantages and disadvantages—Experience and review of literature. The 
Egyptian Journal of Otolaryngology, 39(1), 127. 
 
2- Ali Maeed, M. A. (2004). Steroid therapy for posttonsillectomy symptoms in adults: A 
randomized, placebo-controlled study. Annals of Saudi Medicine, 24(5), 365–367. 
 
3- Álvarez Palacios, I., González-Orús Álvarez-Morujo, R., Alonso Martínez, C., et al. 
(2017). Postoperative pain in adult tonsillectomy: Is there any difference between the 
technique? Indian Journal of Otolaryngology and Head & Neck Surgery, 69, 187–193. 
 
4- Baugh, R. F., Archer, S. M., Mitchell, R. B., et al. (2011). Clinical practice guideline: 
Tonsillectomy in children. Otolaryngology–Head and Neck Surgery, 144(1 Suppl), S1–
S30. 
 
5- Cohen, N., & Sommer, D. D. (2016). Post-tonsillectomy pain control: consensus or 
controversy?. Pain management, 6(1), 31-37. 
 
6- Egeli, E., & Akkaya, S. (1997). The effect of peritonsillar corticosteroid infiltration in 
tonsillectomy. Auris Nasus Larynx, 24, 179–183. 

 
 
 
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7- Grainger, J., & Saravanappa, N. (2008). Local anesthetic for post-tonsillectomy pain: A 
systematic review and meta-analysis. Clinical Otolaryngology, 33, 411–419. 
 
8- Hermans, V., De Pooter, F., De Groote, F., et al. (2012). Effect of dexamethasone on 
nausea, vomiting, and pain in pediatric tonsillectomy. British Journal of Anaesthesia, 
109(3), 427–431. 
 
9- Isaacson, G. (2012). Tonsillectomy healing. Annals of Otology, Rhinology & 
Laryngology, 121(10), 645–649. 
 
10- 
Park, S. K., Kim, J., Kim, J. M., et al. (2015). Effects of oral prednisolone on 
recovery after tonsillectomy. Laryngoscope, 125(1), 111–117. 
 
11- 
Robinson, S. R., & Purdie, G. L. (2000). Reducing post-tonsillectomy pain with 
cryoanalgesia: A randomized controlled trial. Laryngoscope, 110, 1128–1131. 
 
12- 
Stavroulaki, P., Skoulakis, C., Theos, E., et al. (2007). Thermal welding versus cold 
dissection tonsillectomy: A prospective, randomized, single-blind study in adult patients. 
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13- 
Steward, D. I., Grisel, J., & Meinzen-Derr, J. (2011). Steroids for improving 
recovery following tonsillectomy in children. Cochrane Database of Systematic Reviews, 
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14- 
Stewart, D. W., Ragg, P. G., Sheppard, S., et al. (2012). The severity and duration of 
postoperative pain and analgesia requirements in children after tonsillectomy, 
orchidopexy, or inguinal hernia repair. Paediatric Anaesthesia, 22(2), 136–143. 
 
15- 
Sutters, K. A., & Isaacson, G. (2014). Post-tonsillectomy pain in children. American 
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16- 
Verma, R., Verma, R. R., & Verma, R. R. (2017). Tonsillectomy: Comparative study 
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17- 
Warnock, F., & Lander, J. (1998). Pain progression, intensity and outcomes 
following tonsillectomy. Pain, 75, 37–45.