Am J Otolaryngol 39 (2018) 476–480

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Am J Otolaryngol
journal homepage: www.elsevier.com/locate/amjoto

Effect of paracetamol/prednisolone versus paracetamol/ibuprofen on T

post-operative recovery after adult tonsillectomy
⁎
Tamer M. Attia
Lecturer at Otolaryngology Department, Faculty of Medicine, Menoufia University, Egypt
Consultant at Otolaryngology, Head & Neck Surgery Department, Specialized Medical Care Hospital, Al Ain, United Arab Emirates

A R T I C LE I N FO A B S T R A C T

Keywords: Objective: To compare the effect of Paracetamol/Prednisolone versus Paracetamol/Ibuprofen on post-operative

Ibuprofen recovery after adult tonsillectomy.
Post-tonsillectomy hemorrhage Background: Various analgesic protocols have been proposed for the control of post-tonsillectomy morbidity
Post-tonsillectomy pain with need for better control in adult population for having higher severity of post-operative pain and risk of
Prednisolone
secondary post-tonsillectomy bleeding.
Post-tonsillectomy vomiting
Methods: This is a prospective cohort study conducted on 248 patients with age of 12 years or older distributed
as two equal groups; the first one receiving Paracetamol/Prednisolone and the second one receiving
Paracetamol/Ibuprofen. Both groups were compared at 7 days post-operative regarding pain at rest, tiredness of
speech, dietary intake, and decrease in sleep duration. Both groups were compared regarding incidence of
nausea and vomiting at 2 days post-operative. The incidence and severity of secondary post-tonsillectomy he-
morrhage was compared between the two groups.
Results: Pain at rest (no swallowing - no talking) was less in group I but not reaching statistical significance
(p = 0.36). In addition, dietary intake was better in group I but not reaching statistical significance (P = 0.17).
However, talking ability was better with statistically significant difference (P = 0.03) in group I. Impairment of
sleep was less with group II but not reaching statistical significance (p = 0.31). The incidence of vomiting at
second post-operative day was less in group I with statistical significance (p = 0.049). The incidence of sec-
ondary post-tonsillectomy bleeding was significantly higher in group II with statistical significance (p = 0.046).
The severity of bleeding episodes was also significantly higher in group II (p = 0.045).
Conclusion: Both ibuprofen and prednisolone were effective as a part of post-operative medication regimen after
adult tonsillectomy. However, prednisolone was superior to ibuprofen regarding improvement of pain at rest,
dietary intake, tiredness of speech and post-operative nausea and vomiting. However, ibuprofen had a better
impact on sleep. The incidence and severity of secondary post-tonsillectomy hemorrhage were significantly
higher with ibuprofen favoring the selection of prednisolone to be combined with paracetamol in the post-
operative medication protocol following tonsillectomy.

1. Introduction to control excess bleeding and may contribute to post-operative pain

Tonsillectomy operation is a frequently performed operation with
an estimated rate of 200,000 procedures performed in the United
Kingdom annually [1] and more than 500,000 in the United States [2].
The rate of tonsillectomy decreases beyond 12 years old but with in-
creasing incidence of post-operative morbidity including post-operative
pain [3], and post-operative bleeding [4]. The increased incidence of
post-operative pain after adult tonsillectomy can be attributed to the
presence of increased fibrosis from previous infections combined with
larger blood vessels. As a result, more cauterization is typically required
[5]. Post-operative nausea and vomiting (PONV) continues to be a
common concern after tonsillectomy. It is a leading cause of dehydra-
tion and unanticipated hospital admissions in post-tonsillectomy pa-
tients and increases the total health care cost [6]. One of the com-
monest reasons for PONV in post-tonsillectomy patients is the
swallowed blood which causes gastrointestinal irritation and thus in-
creases the likelihood of post-operative nausea and vomiting [7].
Opioids are effective in controlling post-operative pain treatment
but they are associated with side effects, such as nausea, vomiting and
sedation, capable of impairing patient comfort after tonsillectomy. Non-

⁎
Specialized Medical Care Hospital, Al Ain, United Arab Emirates.
E-mail address: tamer.attia@smchosp.com.

https://doi.org/10.1016/j.amjoto.2018.05.002
Received 29 April 2018
0196-0709/ © 2018 Elsevier Inc. All rights reserved.

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T.M. Attia
opioid analgesics are therefore the first line analgesics for post-opera-
tive pain management after tonsillectomy. [8] Paracetamol has been
used widely as post-operative analgesic after tonsillectomy with com-
parable analgesic effect to opioids. [9] NSAIDs have taken an essential
role in the management of post-tonsillectomy pain with various drugs
and different dose regimens. However several studies have raised the
issue of increased incidence of secondary post-tonsillectomy hemor-
rhage with NSAIDs [10]. This should be considered while planning the
post-operative medication regimen.
Corticosteroids have been recently added to post-operative medi-
cation protocols at a wide scale to minimize the post-operative nausea
and vomiting and augment the analgesic effect of other non-opioid
analgesics through their anti-inflammatory effects [11]. The aim of this
study is to compare the effect of two protocols of Paracetamol/Ibu-
profen versus Paracetamol/Prednisolone on post-operative recovery
after tonsillectomy with assessment of the risk of secondary post-ton-
sillectomy hemorrhage with each protocol.
2. Patients and methods
This is a prospective cohort study conducted on 248 patients in-
dicated for tonsillectomy recruited at the department of
Otolaryngology, Al Ain Specialized Medical Care Hospital during the
period from September 2015 to March 2018. Approval of the ethical
committee of the hospital was taken and each patient or his legal re-
presentative had signed consent before participating in the study.
Patients indicated for tonsillectomy with an age of 12 years old or
above were included in the study. This age was selected because of
increasing perception of post-tonsillectomy pain in this age group. Also,
younger patients fail to subjectively assess their pain scores. Any pa-
tient with systemic disease increasing the risk of infection like diabetes
mellitus was excluded from the study. Patients with neurological dis-
order or taking medications with affection of the perception of pain
were excluded from the study. Patients with contraindication to para-
cetamol, prednisolone or ibuprofen like hypersensitivity to the drug,
peptic ulcer, hepatic or renal dysfunction were excluded from the study.
Studied patients were distributed randomly into two equal groups I
and II according to the administered post-operative analgesic regimen
utilizing block randomization method using 62 blocks each comprising
4 patients with 6 patterns for every block one of which was selected
randomly using random numbers generated by Excel program. All pa-
tients were subjected to coblation tonsillectomy performed by the au-
thor under general anesthesia.
2.1. Post-operative analgesic regimens
Group I: 124 patients received prednisolone in a dose of 1 mg per Kg
per day with a maximum of 60 mg per day in three divided doses for
10 days along with paracetamol in a dose of 1 g per dose every 4–6 h as
needed with a maximum of 5 doses per day.
Group II- Patients received 200–400 mg of ibuprofen orally every
6 h with a maximum of 3200 mg per day for 10 days along with para-
cetamol in a dose of 1 g per dose every 4–6 h as needed with a max-
imum of 5 doses per day.
2.2. Outcomes assessment
Four parameters were assessed at the seventh post-operative day to
reflect the post-operative pain: pain at rest (no swallowing - no talking),
dietary intake, decrease in number of sleeping hours per day and tiredness
of speech. Pain at rest was assessed using numerical pain scale ladder for
adults with a score out of 10. Dietary intake and tiredness of speech were
assessed using a visual analog scale comparing speech ability with the
preoperative state giving a score out of 10. The primary end-point was the
incidence of severe morbidity defined as a score > 6. Incidence of vo-
miting was assessed at the second post-operative day for both groups.
477
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Am J Otolaryngol 39 (2018) 476–480
The incidence of secondary post-tonsillectomy hemorrhage was re-
corded. The severity of secondary post-tonsillectomy hemorrhage was
classified according to the scale adopted by Samy et al. [12]. They
stated grade A for anamnestically recorded blood‑tinged sputum. In A1;
wound was and stayed dry with no coagulum upon inspection. In A2;
there was coagulum upon inspection with dry wound after removal. In
grade B, bleeding was active under examination with medical treatment
necessary followed by dry wound and blood count was in normal range
and no shock. In grade C; surgical treatment with general anesthesia
was indicated with blood count still in normal range and no shock. In
grade D; there was dramatic hemorrhage, hemoglobin decreased, blood
transfusion was required with difficult surgical treatment and intensive
care may be necessary. In grade E; Exitus occurred due to hemorrhage
or hemorrhage-related complication.
2.3. Statistical analysis
Data were collected, tabulated and statistically analyzed using an
IBM personal computer with Statistical Package of Social Science
(SPSS) version 20 and Epi Info 2000 programs. Descriptive statistics for
quantitative data presented as mean (¯X) and standard deviation (SD).
Qualitative data presented as numbers and percentages (%). Data
turned up to be non-normally distributed according to Kolmogorov-
Smirnov test. Mann Whitney U test was used to compare quantitative
data of both groups. Chi- squared test (χ2) was used to study associa-
tion between two qualitative variables. Two sided p value of (≤0.05)
was considered statistically significant.
3. Results
In the current study, two groups were studied including 124 patients
in each with no significant difference between the two groups regarding
age, sex and preoperative sleep duration indicating uniformity of both
study groups (p > 0.05 for all) (Table 1).
In the current study pain at rest was less in group I but not reaching
statistical significance (p = 0.36). In addition, dietary intake was better
in group I but not reaching statistical significance (P = 0.17). However,
talking ability was better with statistically significant difference
(P = 0.03) in group I. On the other hand, impairment of sleep was less
with group II but not reaching statistical significance (p = 0.31)
(Table 2). The incidence of vomiting at second post-operative day was
less in group I with statistical significance (p = 0.049) (Table 3).
In the current study, the incidence of secondary post-tonsillectomy
bleeding was significantly higher in group II with statistical significance
(p = 0.046) (Table 4). In addition, the severity of bleeding episodes was
also significantly higher in group II (p = 0.045) according to Samy et al.
classification of secondary post-tonsillectomy bleeding (Table 5).
4. Discussion
Tonsillectomy operation can be followed by several aspects of
morbidity including pain, dysphagia, impaired speech, impaired sleep,
nausea and vomiting. These manifestations are interconnected with
pain being a major cause for difficult swallowing, decrease in sleep
Table 1
Demographic and clinical data of both study groups.
Item Group I Group II Statistical test P value
Age 18.65 ± 6.24 19.02 ± 6.13 U = 7261 0.45
Sex Male 76 66 Chi = 1.6476 0.2
Female 48 58
Preoperative sleep 7.5 ± 0.94 7.69 ± 0.69 U = 7055.5 0.23
duration
Chi: Chi square test.
U: U value of Mann Whitney U test.
T.M. Attia Am J Otolaryngol 39 (2018) 476–480

Table 2
Comparison groups I and II regarding parameters of post-operative pain assessment.
Parameter Group I Group II Test of significance p value

No. % No. %

Pain at rest High pain 21 16.9 28 22.6 Chi =1.25 0.36

Low pain 103 83.1 96 77.4
Dietary habits Highly impaired 24 19.4 33 26.6 Chi =1.85 0.17
Minimally impaired 100 80.6 91 73.4
Tiredness of Speech High tiredness 10 8.1 21 16.9 Chi = 4.46 0.03
Low tiredness 114 91.9 103 83.1
Decrease of sleeping hours per day 1.33 ± 0.49 1.25 ± 0.43 U = 7114.5 0.31
(Mean ± SD)

Chi: Chi square test.

U: U value of Mann–Whitney U test.

Table 3 well known and also has been found to be comparable to opioids as
Comparison between study groups regarding incidence of vomiting at first post- shown by Bedwell et al. in 2014 [14] and Kelly et al. in 2015 [15]. This
operative day. makes prednisolone and ibuprofen are the targets of evaluation by the
Incidence of vomiting Group I Group II Chi square test P value study.
The current study evaluated the 5 aspects of post-operative recovery
No. % No. % after tonsillectomy. Pain at rest, difficult swallowing, tiredness of
speech and decrease in sleep duration were evaluated at the seventh
Vomiting 7 5.6 16 12.9 3.88 0.049
No vomiting 117 94.4 108 87.1 post-operative day being the time of maximum pain intensity. However
Total 124 100 124 100 nausea and vomiting were evaluated at two days post-operatively being
at their maximum intensity in the early post-operative period. In ad-
dition, the study evaluated the side effects of both protocols regarding
Table 4 the incidence and severity of secondary post-tonsillectomy hemorrhage.
Comparison between study groups regarding incidence of secondary post-ton- In the current study, pain at rest and dietary intake were better in
sillectomy bleeding. group I but not reaching statistical significance. However, talking
Incidence of bleeding Group I Group II Chi square test P value ability, nausea and vomiting were significantly better in group I also.
On the other hand, sleep was better in group II but not reaching sta-
No. % No. % tistical significance. The powerful antioedematous effect of pre-
Bleeding 3 2.4 10 8.1 3.98 0.046
dnisolone contributes to the better talking ability and swallowing
No bleeding 121 97.6 114 91.9 capability as the oropharyngeal oedema following tonsillectomy im-
Total 124 100 124 100 pairs the ability of speech and swallowing. In addition, corticosteroids
are known to increase the appetite and this may contribute to the im-
proved dietary intake. Corticosteroids also are well known to have a
Table 5 powerful antiemetic effect following anesthesia in general with similar
Comparison between groups I and II regarding severity of secondary post-ton- effect after tonsillectomy [13].
sillectomy bleeding.
In a similar study, Aveline et al. in 2015 [16] compared the ad-
Grade Group I Group II Chi square test p value ministration of paracetamol/prednisolone versus paracetamol/ibu-
profen analgesic protocols after tonsillectomy in 1231chidren. They
Grade A2 2 0 8.07 0.045
Grade B 1 7
found that Ibuprofen reduced the incidence of pain scores≥6 on day 7
Grade C 0 2 with statistical significance (P = 0.009). This finding is against our
Grade D 0 1 finding which may be attributed to the lower dose of prednisolone used
Total 3 10 in their study being 0.5 mg / kg compared to 1 mg /kg in our study
which led to unfortunate lower ant-inflammatory and analgesic effect.
On the other hand, Aveline et al. found that Ibuprofen enhanced sleep
duration and tiredness of speech. On the other hand, vomiting after
quality on post-operative day 0 (P < 0.0001) and post-operative day 7
tonsillectomy contributes to the post-operative pain and discomfort. All
(P = 0.02). This matches the finding of our study but it doesn't reach
these aspects have a great burden on the patient with impaired quality
statistical significance in our study. This difference may be attributed to
of life. Several medical protocols have been proposed to improve the
difference in sample size. In addition, Aveline et al. stated that Ibu-
post-operative recovery after tonsillectomy.
profen enhanced oral intake on post-operative day 0 (P < 0.0001).
In the current study, we evaluated two protocols for post-operative
This is against our finding of better improvement of dietary intake with
management of patients after tonsillectomy operation. We have chosen
prednisolone. This can be clearly explained by the previously proposed
the age group to be ≥ 12 years old because patients in such age are
improvement of pain in their study. In addition, we attribute such
more cooperative than younger patients with more accurate estimation
better dietary intake with prednisolone to the more decrease in or-
of symptom scores. The first protocol combined the use of prednisolone
opharyngeal oedema and increased appetite with steroids. Finally,
and paracetamol to combine the analgesic effect of paracetamol which
Aveline et al. found that and post-operative nausea and vomiting were
has been found to be comparable to opioids [9] and the established ant-
significantly lower with ibuprofen (P = 0.01). Their finding is against
inflammatory/antioedematous effect of prednisolone together with its
our finding and the finding of other studies which highlighted the role
recorded analgesic effect as shown by Dan et al. in 2010 [13]. The
of steroids in minimizing post-operative nausea and vomiting. [17–19]
second protocol combined the use of ibuprofen and paracetamol adding
In addition, ibuprofen being a non-steroidal ant-inflammatory drug can
the analgesic and anti-inflammatory prosperities of ibuprofen to the
provoke nausea and vomiting by its effect on gastric mucosa.
analgesic effect of paracetamol. The analgesic efficacy of ibuprofen is
Other studies evaluated the use of post-operative prednisolone as a

478

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T.M. Attia
part of post-tonsillectomy medication regimen. Palme et al. in 2000
[17] conducted a double-blind, randomized, placebo-controlled trial
comparing a 7-day course of daily placebo or prednisolone. They found
that on post-operative days 4 to 7, the steroid group experienced sig-
nificantly less nausea and vomiting. Paracetamol use was significantly
less indicating less pain in the steroid group on days 2, 7, and 8 Ma-
cassey et al. in 2012 [18] compared a 5-day course of oral prednisolone
with placebo in a pediatric population (3–16 years) undergoing tonsil-
lectomy. They found that there was no significant difference between
the 2 groups when analyzed for differences in pain, nausea and vo-
miting, return to normal diet, return to normal activity, bedtime, and
number of times awake during the night. These findings can be ex-
plained by their given lower dose of prednisolone and the shorter
duration of treatment. Park et al. in 2015 [19] conducted a prospective,
randomized, controlled trial on 198 patients scheduled for elective
tonsillectomy with or without adenoidectomy comparing a post-op-
erative course of prednisolone and no prednisolone over 7 days. No
statistically significant differences in pain, diet, activity, rate of minor
bleeding, nausea/vomiting, fever, or sleep disturbance were observed
between the groups on day 1. On day 7, however, in pediatric patients,
differences in pain (P = 0.001), diet (P = 0.001), activity (P = 0.0040,
and sleep disturbance (P = 0.04) were observed. These findings match
our findings except for sleep duration.
In the current study, the incidence of secondary post-tonsillectomy
hemorrhage were significantly lower with the paracetamol – pre-
dnisolone protocol when compared with paracetamol - ibuprofen pro-
tocol being 2.4% and 8.1% respectively. In addition, the severity of
secondary post-tonsillectomy hemorrhage was significantly higher in
the paracetamol - ibuprofen group according to the classification
system adopted by Samy et al. in 2001 [12]. This classification system
offers a practical approach for assessment of secondary post-tonsil-
lectomy hemorrhage. In our study, two out of three patients with sec-
ondary post-tonsillectomy hemorrhage in paracetamol – prednisolone
group were found to have only a blood clot at the bed with no further
bleeding after its removal. However, one patient needed medical
treatment to stop the bleeding but with no shock. On the other hand, 7
out of 10 patients with secondary post-tonsillectomy hemorrhage in the
paracetamol - ibuprofen group needed only medical treatment, with
one patient needed surgical intervention under general anesthesia but
with no shock or change in blood indices. The remaining patient suf-
fered from severe hemorrhage with shock and the surgical control was
difficult in the operative theater with blood being transfused to the
patient.
Our finding of increased incidence of secondary post-tonsillectomy
hemorrhage with ibuprofen usage is supported by the findings of sev-
eral previous studies. Smith and Wilde in 1999 [20] found a significant
increase in secondary hemorrhage rate when on regular NSAIDs. Marret
et al. in 2003 [21] in a meta-analysis post-operative use of conventional
NSAIDs increases the risk of reoperation for hemostasis after tonsil-
lectomy. Møiniche et al. in 2003 [22] in their meta-analysis found an
evidence to suggest that the likelihood of reoperation due to bleeding
increases when NSAIDs are administered, particularly in the post-op-
erative period. D'Souza et al. in 2015 [23] found that use of ibuprofen
after intracapsular tonsillectomy in children is associated with statisti-
cally significant increase in post-tonsillectomy hemorrhage requiring
return to the operating room, as well as an increase in overall rates of
both primary and secondary post-tonsillectomy hemorrhage. Mudd
et al. in 2017 [24] found that the risk for post-tonsillectomy hemor-
rhage with use of post-operative ibuprofen was increased in patients
12 years or older. Hemorrhage severity was significantly increased with
ibuprofen use when using transfusion rate as a surrogate marker for
severity.
These findings can be explained by the fact stated by Schafer in
1995 [25] who clarified that non-aspirin NSAIDs produce a systemic
bleeding tendency by reversibly inhibiting platelet cyclooxygenase,
thereby blocking formation of thromboxane A2. Effects of individual
479
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Am J Otolaryngol 39 (2018) 476–480
NSAIDs on ex vivo platelet function, bleeding time, and clinical
bleeding depend at least in part on dose, serum level, and drug half-life.
On the other hand, Krishna et al., in 2003 [26] in a meta-analysis
found an increased risk of post-tonsillectomy hemorrhage with the use
of aspirin after tonsillectomy and a non-significant increased risk of
bleeding for non-aspirin NSAIDs. Riggin et al. in 2013 [27] conducted a
systematic review & meta-analysis of 36 randomized controlled trials to
find no apparent effects of non-steroidal anti-inflammatory agents on
the risk of bleeding after tonsillectomy.
Some of the authors proposed that the use of systemic steroid was
associated with increased bleeding risk. Plante et al. in 2012 [28] in a
systematic review and meta-analysis found that systemic steroids do not
appear to increase bleeding events after tonsillectomy but their use was
associated with a raised incidence of operative re-interventions for
bleeding episodes, which may be related to increased severity of
bleeding events. However 28 of 29 included studies in this meta-ana-
lysis were evaluating the intravenous dexamethasone with one study
only evaluating prednisolone. In addition, Suzuki et al. in 2014 [29] in
a systematic review and meta-analysis found that the rate of reopera-
tion for secondary post-tonsillectomy hemorrhage was significantly
higher in the steroid group than in the control group for children
(P < 0.001) but not for adults. Again this study evaluated the use of
dexamethasone not prednisolone.
On the other hand, Palme et al. in 2000 [17] found a non-significant
difference between a 7-day course of daily placebo or prednisolone
regarding post-tonsillectomy bleeding. Aveline et al. in 2015 [16] found
that the incidence of bleeding requiring reoperation was comparable
between paracetamol/prednisolone versus paracetamol/ibuprofen
(p = 0.8). Park et al. in 2015 [19] found no statistically significant
differences in rate of minor bleeding between paracetamol/pre-
dnisolone versus paracetamol/ibuprofen analgesic protocols. The effect
of prednisolone on hemostasis has been first proposed by Thong et al. in
1978 [30]. They stated that conventional clinical doses of prednisone
did not impair platelet function and did not enhance primary hae-
mostasis in normal subjects as measured by the bleeding time. Although
their results failed to support a useful clinical role for glucocorticoids in
disorders of primary hemostasis, they did not completely exclude one.
The limitations of our study include the relatively small number of
patients compared with other studies. This can be explained by that this
study included the operations performed by a single surgeon in a single
center. Also the rate of tonsillectomy decreases after 12 years. Other
methods of tonsillectomy other than coblation should be assessed for
control of post-operative pain.
5. Conclusion
Both ibuprofen and prednisolone were effective as a part of post-
operative medication regimen after adult tonsillectomy. However,
prednisolone was superior to ibuprofen regarding improvement of pain
at rest, dietary intake, tiredness of speech and post-operative nausea
and vomiting. However ibuprofen had a better impact on sleep duration
compared with prednisolone. The incidence and severity of secondary
post-tonsillectomy hemorrhage were significantly higher with ibu-
profen favoring the selection of prednisolone to be combined with
paracetamol in the post-operative medication protocol following ton-
sillectomy.
Conflict of interest statement
No potential conflict of interest relevant to this article was reported.
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