Am J Otolaryngol xxx (xxxx) xxx–xxx

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

Association of ibuprofen use with post-tonsillectomy bleeding in older

children
⁎
Robert T. Swansona, Jane R. Schubartb, Michele M. Carrc,
a
College of Medicine, The Pennsylvania State University, College of Medicine, Hershey, PA, United States
b
Department of Public Health Sciences, Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA, United States
c
Department of Otolaryngology-Head and Neck Surgery, West Virginia University, Morgantown, WV, United States

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

Keywords: Objective: Evaluate post-tonsillectomy outcomes in children discharged with ibuprofen versus those without.
Pediatric Methods: This was a retrospective review of children who underwent tonsillectomy ± adenoidectomy from
Ibuprofen 2012 to 2016 at a tertiary care children's hospital. Main outcome measures included bleed rates, ER visits, and
Tonsillectomy nurse phone calls.
Hemorrhage
Results: Seven hundred and seventy-three patients were included; 504 had ibuprofen at discharge (ID) and 269
Surgery
did not (NID). There were significant differences in mean age, 6.7 years in the ID group years versus 8.6 for the
NID group (P < 0.001). Indication for surgery was sleep apnea in 70.5% of ID patients and 44.0% of NID
patients (P < 0.001). Post-tonsillectomy bleeds occurred in 8.7% in the ID group and 5.9% of the NID group
(P = 0.168). Other outcome measures revealed no significant differences between the two groups. There was no
significant difference in the outcome measures between patients with sleep apnea or recurrent tonsillitis. Age
was important; 12.1% of children 9–18 years versus 4.8% in children 3.1–6 years (P = 0.006) had post-tonsil-
lectomy bleeding. For children 9–18 years old, 16.7% in the ID group bled versus 7.5% in the NID group
(P = 0.039). Logistical regression revealed that age contributed to post-op bleeding, and ibuprofen contributed
to number of ER visits.
Conclusion: Ibuprofen is associated with significantly elevated post-tonsillectomy bleeding in older children,
further research is needed and other analgesics should be considered.

1. Introduction
Tonsillectomy, with or without adenoidectomy, is the second most
common operation performed on children within the United States [1],
as over 530,000 operations are performed annually in children younger
than 15 years of age in the U.S. [2]. Although the indications for ton-
sillectomy have evolved, they are generally performed in response to
chronic infections, obstruction, neoplastic changes, or biopsy require-
ments. With regard to age, the highest frequency occurs in the 5–7 year
old age group, with the peak typically occurring in the 6th year [3].
A common complication of tonsillectomy, and the primary interest
of our study, is post-operative hemorrhage, occurring in 1–12.5% of
pediatric patients in the literature [4–14], with 1 out of 40,000 patients
dying secondary to bleeding [15]. Other complications include pain,
dehydration, weight loss, low-grade fever, and pulmonary edema. Post-
op bleeding may be classified as primary (transpiring within the first
24 h), or secondary (occurring between 1 and 10 days). Post-tonsil-
lectomy bleeding can be expensive. Harounian et al. [16] found a mean
national 30-day post-operative cost of $4580 for those receiving out-
patient treatment (not requiring hospitalization or surgery) for a bleed,
compared to $370 for those without post-operative bleeding events or
bleeding events not treated. Likewise, a retrospective study in Utah in
2015 revealed that the mean cost for a visit to the emergency depart-
ment status-post tonsillectomy was $1420 (95% CI, $1104–$1737), but
rose to $1502 (95% CI, $1216–$1787) when hemorrhage was present
and managed [17].
Historically, surgeons have avoided ibuprofen for pain control after
tonsillectomy because of its perceived association with bleeding.
However, with recent studies not reporting a significant difference in
bleed rates in children given NSAIDs (such as ibuprofen) after tonsil-
lectomy, the American Academy of Otolaryngology suggested in their
2011 tonsillectomy guidelines that NSAIDs can be safely used and
should be promoted for pain control [18]. Additionally, the U.S. Food
and Drug Administration (FDA) published a safety review in August
2012 indicating that certain children may be at risk of serious adverse
events or death related to use of codeine post-tonsillectomy due to the

⁎
Corresponding author at: Dept. of Otolaryngology-Head and Neck Surgery, 1 Medical Center Drive, PO Box 9200, West Virginia University, Morgantown, WV 26501, United States.
E-mail address: mmc0040@hsc.wvu.edu (M.M. Carr).

https://doi.org/10.1016/j.amjoto.2018.05.009
Received 24 February 2018
0196-0709/ © 2018 Elsevier Inc. All rights reserved.

Please cite this article as: Swanson, R.T., Am J Otolaryngol (2018), https://doi.org/10.1016/j.amjoto.2018.05.009
R.T. Swanson et al.
possibility of having a hyperactive cytochrome P450 2D6 enzyme.
Being an “ultra-rapid metabolizer” can increase the amount of mor-
phine in the blood after taking codeine and result in potentially fatal
side effects [19]. After the FDA went on to add a Boxed Warning in
February of 2013 [20], many post-tonsillectomy patients at Penn State
Hershey Children's Hospital were given discharge regimens including
ibuprofen. In-house review suggested a slight increase in the percentage
of children who had post-tonsillectomy hemorrhages, raising concern
and stimulating our own investigation of bleeding and ibuprofen use
after tonsillectomies.
The main objective of this study was to analyze post-tonsillectomy
outcomes among patients discharged with ibuprofen compared to those
not discharged with ibuprofen, with focus on hemorrhage rates, ER
visits, and nurse phone calls.
2. Method
A retrospective study was performed on pediatric patients who had
tonsillectomy with or without adenoidectomy at the Penn State Hershey
Children's Hospital in the years 2012 to 2016. This study was approved
by the Penn State Institutional Review Board (# 3013). To identify
patients, CPT (Current Procedural Terminology) codes for tonsillectomy
along with an age limit at time of operation (1–18 years old) were used
to query the hospital database. Once these patients were selected, data
was manually retrieved from the electronic medical record and re-
corded. All patients with data available were included; those with in-
complete records were excluded. Two surgeons were involved. Patients
included in the study were either discharged with ibuprofen or no
ibuprofen. All patients were additionally prescribed acetaminophen and
some were prescribed oral narcotics, the latter mainly because of sur-
geon preference. In a small number, the narcotic was used because of
inadequate pain control in hospital with acetaminophen and ibuprofen.
All prescriptions were to be used as needed.
Indications for surgery included: obstructive sleep apnea (OSA),
recurrent tonsillitis, asymmetrical tonsils, failure to thrive (FTT) to-
gether with tonsillar hypertrophy, or a combination of any of these.
These were consolidated into 3 groups: OSA, recurrent tonsillitis, or
other (which included asymmetrical tonsils and FTT). Sample cohorts
were also divided into 4 age categories based on the patient's age at the
time of operation: category 1 (1–3 years old), category 2 (3.1–6 years
old), category 3 (6.1–9 years old), and category 4 (9.1–18 years old).
Children were grouped into 3 year categories, with the older children
pooled because the groups were small.
Patient post-tonsillectomy outcomes were reviewed with focus on
bleeding rates, ER visits, total number of nurse phone calls, and reason
for the call. Patients were considered to have a post-tonsillectomy he-
morrhage if they were treated for post-tonsillectomy hemorrhage in any
emergency department within 1 month of tonsillectomy. This was
chosen because of the significantly higher post-tonsillectomy health
care costs for children who visit the ER for bleeding even if they are not
taken back to the operating room for treatment. All phone calls made to
nursing staff had records that were reviewed for a month after tonsil-
lectomy. The reason for each phone call was recorded as: pain and/or
decreased oral intake, bleeding, or other. Some examples of call reasons
for those in the “other” category included: halitosis, fever, and cough.
Patients who underwent tonsillectomy but had no record of nurse
phone calls, emergency department visits, or 1-month follow-up visit
were excluded from the study.
Costs for management in our hospital of patients who had post-op
bleeding was obtained from the hospital cost accounting center.
Pearson chi-squared tests, likelihood ratios, and linear-by-linear
association tests were used with statistical significance at P < 0.05.
Non-parametric statistics were calculated as appropriate, and logistic
regression analysis was used. The purpose of the multivariable regres-
sion model was to understand the association between discharge with
ibuprofen and post tonsillectomy bleeding, after controlling for a set of
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Am J Otolaryngol xxx (xxxx) xxx–xxx
covariates. The allowable number of independent variables was based
on the general rule of number of events divided by approximately 15
(10−20). Our model includes 5 independent variables. Therefore the
number of patients required for the model is 50–100. Our model in-
cludes 60 patients with the outcome event. The main independent
variable was ibuprofen after discharge (dichotomous), plus the fol-
lowing covariates: sex (dichotomous), age (categorical with 3 levels),
indication recurrent tonsillitis (dichotomous), and indication other than
OSA or recurrent tonsillitis (dichotomous).
3. Results
A total of 773 pediatric patients were reviewed in the study, in-
cluding 366 (47.3%) females and 407 (52.7%) males. The age at the
time of operation ranged from 1 to 18 years old, with mean age of 7.34
(SD = 3.84). Sixty point 5% of patients were Caucasian and 12.8% were
African American. Most patients had cautery tonsillectomy; 33 had
coblation used. Post-tonsillectomy patients were separated into 2
groups: 504 patients who were discharged with ibuprofen (ID) and 269
patients who did not receive ibuprofen at discharge (NID). There was
no difference in gender, or method of tonsillectomy between the
groups. The mean age for the ID group was 6.7 years while the NID
mean age was 8.6 (P < 0.001).
Forty-four patients (8.7%) in the ID group and 16 patients (5.9%) in
the NID group had post-tonsillectomy bleeding (Table 1). There was no
significant difference in post-tonsillectomy hemorrhage between the 2
groups (P = 0.168) or in the number of ER visits between the 2 groups
(P = 0.092). About half (51.67%) were treated in the operating room
for their post-tonsillectomy hemorrhage. Power calculation suggests
that with 60 subjects, a difference of 46% between the groups would be
detected with 80% certainty and alpha of 0.05. There was no difference
in percentage of post-operative bleeding when genders were compared
(P = 0.874) or races were compared (P = 0.262).
One hundred fifty three (30.4%) patients in the ID group had a
caregiver call the otolaryngology clinic nurse during the 1-month
follow-up period, while 79 (29.4%) patients in the NID group had
phone calls made by caregivers (P = 0.775). There was also no sig-
nificant difference in the reason for the phone call (P = 0.801)
(Table 2).
There was a significant difference in indications between the two
groups; the majority in the ID group had tonsillectomy because they
had OSA (70.5%) while in the NID group it was recurrent tonsillitis
(56%) (P < 0.001). However, there was no significant difference in
patient outcomes, including post-op bleeding, between patients with
indications of OSA or recurrent tonsillitis (Table 3).
Patients in different age groups were different for indication for
surgery. About 92% of the 2 youngest groups had OSA, compared to
75% in the 6–9 year old group and 66% in the over 9 year old group
Table 1
Post-tonsillectomy bleeding comparison.
Characteristic Ibuprofen (n) No Ibuprofen (n) Total (n)
Sample size 504 269 773
Post-op bleed 44 (8.7%) 16 (5.9%) 60
Post-op bleed treated in the OR 20 (4.0%) 11 (4.1%) 31
Table 2
Phone calls to nursing: reasons for each group.
Discharge Med Nurse Call Reason (N (%))
Bleeding Pain/Decreased Oral Intake Other Total
Ibuprofen 24 (15.7) 72 (47.1) 57 (37.3) 153
No ibuprofen 9 (11.4) 41 (51.9) 29 (26.7) 79
R.T. Swanson et al. Am J Otolaryngol xxx (xxxx) xxx–xxx

Table 3 Table 5
Indications for tonsillectomy and patient outcomes. Logistical regression: post-tonsillectomy bleeding.
Characteristic Indication P - value Variable Odds ratio 95% CI P - value

OSA Recurrent Other Male, age 3.1–6 years, indication OSA, no Reference
tonsillitis discharge ibuprofen
Female 0.98 0.57–1.68 0.947
Frequency (n) 621 134 18 – 1–3 years 2.02 0.74–5.49 0.167
Bleed % 7.57 8.21 11.11 0.839 6.1–9 years 1.53 0.71–3.32 0.280
Nurse phone calls (n 181 (29.2) 47 (35.1) 4 (22.2) 0.305 9.1–18 years 3.19 1.58–6.48 0.001
(%)) Indication recurrent tonsillitis 0.94 0.45–1.95 0.857
ER visits (n (%)) 75 (12.1) 21 (15.7) 1 (5.6) 0.347 Discharge with ibuprofen 1.85 0.99–3.46 0.053

OSA = obstructive sleep apnea.

Table 6
Logistical regression: number of ER visits.
Table 4
Variable Odds ratio 95% CI P - value
Age Categories and % of post-op bleeding within each category.
Age Categories n Overall bleed ID bleed n NID bleed n P - value Male, age 3.1–6 years, indication OSA, no Reference
(years) n (%) (%) (%) discharge ibuprofen
Female 0.68 0.44–1.04 0.078
1–3 65 6 (9.2) 4 (8.3) 2 (11.8) 0.677 1–3 years 1.28 0.58–2.86 0.539
3.1–6 290 14 (4.8) 12 (5.7) 2 (2.6) 0.276 6.1–9 years 0.94 0.52–1.69 0.841
6.1–9 203 14 (6.9) 10 (7.4) 4 (6.0) 0.715 9.1–18 years 1.54 0.88–2.69 0.128
9.1–18 215 26 (12.1) 18 (16.7) 8 (7.5) 0.039 Indication recurrent tonsillitis 1.32 0.74–2.35 0.349
Indication other than OSA or recurrent 0.53 0.07–4.09 0.542
ID = Ibuprofen prescription given at discharge. tonsillitis
Discharge with ibuprofen 1.75 1.06–2.9 0.029
NID = No Ibuprofen prescription given at discharge.

(p < 0.001). This variable was included in the logistic regression

4. Discussion
model.
There were also no differences between patients of different ages for
Ibuprofen's mechanism of action makes its post-operative use and
nurse phone calls, call reason, or ER visits, but there were significant
subsequent bleeding a legitimate concern. As a non-selective, reversible
differences in bleeding. Children aged 9–18 had a higher incidence of
inhibitor of both COX-1 and COX-2, ibuprofen produces its effect
bleeds (12.1%) versus those children aged 3.1–6 who had a bleed rate
mainly through reducing breakdown of arachidonic acid [9]. As it
(4.8%) (P = 0.006). Comparison of the ID and NID groups showed that
lessens the production of arachidonic acid metabolites, it is effective at
16.7% of children aged 9–18 in the ID group bled versus 7.5% in the
reducing both post-tonsillectomy pain and disrupting platelet function/
NID group (P = 0.039) (Table 4) Children in the 9–18 year old age
hemostasis [9]. The benefit of its pain reduction properties may make it
group had a significantly lower ibuprofen mg/kg dose at 8.77 mg/kg
an enticing option for post-tonsillectomy pain control, but its anti-pla-
(P < 0.001, 95% CI 8.25–9.28) versus children aged < 9 years, whose
telet effect is worrisome. Previous authors have stated that bleeding
mean dose was 11.75 mg/kg (95% CI 8.60–14.9). Children over 9 years
time remains within normal limits in children with normal coagulation
were discharged with ibuprofen in 50.2% percent of cases, while chil-
systems who take ibuprofen [9,14].
dren younger than 9 were in 71.0% of cases (P < 0.001).
Our study found that 8.7% of those patients who were discharged
Cost data from our hospital was available for 40 of the patients who
with ibuprofen had post-tonsillectomy bleeding, which falls within the
had post-op bleeding recorded. For 20 children who were seen in the ER
range of that reported in past literature (Table 7) [4–14]. All of these
and were taken to the OR, mean costs were $5238 ($4677 for children
relevant studies we identified compared post-operative bleeding in
prescribed ibuprofen and $6498 for children who were not). For 14
patients who were given ibuprofen post-tonsillectomy versus patients
children who were seen in the ER but did not go to the OR, mean costs
who did not receive ibuprofen post-tonsillectomy. Ozkiris et al. [6]
were $3756 ($3579 for children prescribed ibuprofen and $4197 for
compared 1 ibuprofen group to 2 different non-ibuprofen discharge
children who were not). Mean costs for children who did not have an
regimens (children received either acetaminophen or metamizole so-
ER visit recorded but were taken to the OR for control of bleeding were
dium instead), the bleeding rates of which were combined together. The
$7734 ($7850 for children prescribed ibuprofen and $7156 for those
rates included from Pfaff et al. [10] are specifically bleed rates that
who were not). There was no significant difference in total costs when
required hospital admission. Higher bleed rates were reported in the
the groups who had been prescribed ibuprofen were compared to the
majority of the ibuprofen user groups when compared to non-ibuprofen
group that had not.
post-operative regimens groups, but p-values were all insignificant ex-
In a logistic regression analysis for the outcome post-tonsillectomy
cept for 2 studies (Table 7). D'Souza et al. [12] and Ferster et al. [13]
bleeding, children aged 9.1–18 years were 3.19 times as likely to have
both found a significant increase in post-tonsillectomy bleed rates for
post-op bleeding as children aged 3.1–6 years (OR = 3.19, P = 0.001).
those patients using ibuprofen post-operatively. In our review of
All other variables in this model were insignificant, including those
D'Souza et al., [12] we focused on their secondary PTH results, as 36%
children discharged with ibuprofen compared those not discharged
of their patients received post-operative ketorolac as well as ibuprofen
with ibuprofen (OR = 1.85, P = 0.053) (Table 5). The model was
(none in their narcotic control group received ketorolac). They felt that
constructed with the reference patient as a male, age 3.1–6 years old,
the ketorolac could have confounded the primary PTH incidence (al-
OSA as the indication for surgery, and discharged without ibuprofen.
though they did not find this) but it should not have affected the sec-
In a model of logistical regression for the outcome “number of ER
ondary PTH results due to the drug's half-life and the time the ketorolac
visits” children discharged with ibuprofen were 1.75 times as likely to
was administered [12]. Ferster et al. included a very large group al-
have an ER visit as children discharged without ibuprofen (OR = 1.75,
lowing a 1.1% difference in bleeding rates between the groups to be
P = 0.029). All other variables were insignificant (Table 6). The re-
statistically significant [13]. Additionally, three studies [4,11,14] in
ference patient was the same as that used for the model in Table 5.
Table 7 also noted that their ibuprofen cohorts were discharged with

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R.T. Swanson et al. Am J Otolaryngol xxx (xxxx) xxx–xxx

Table 7
Pediatric studies with post-tonsillectomy ibuprofen use and bleed rates.
Study ID (N) NID (N) ID bleed n (%) NID bleed n (%) Odds ratio 95% CI P - value

Our study 504 269 44 (8.7) 16 (5.9) 1.51 0.84–2.74 0.168

Mattos et al.b [4] 783 282 66 (8.4) 23 (8.2) 1.04 0.63–1.70 0.89
Bedwell et al. [5] 489 177 17 (3.5) 3 (1.7) 2.09 0.61–2.72 0.23
Ozkiris et al. [6] 115 225 6 (5.2) 8 (3.6)a 1.53 0.42–5.56 “insig.”
Kelly et al. [7] 41 45 3 (7.3) 2 (4.0) 1.70 0.27–10.71 0.67
Yaman et al. [8] 62 109 3 (4.8) 4 (3.7) 1.34 0.29–6.17 0.498
Harley et al. [9] 16 11 2 (12.5) 0 (0) 3.97 0.17–91.02 0.4986
Pfaff et al. [10] 2697 3317 98 (3.6) 113 (3.4) 1.07 0.81–1.41 0.63
St. Charles et al.b [11] 55 55 4 (7.3) 5 (9.1) 0.78 0.20–3.09 0.74
D'Souza et al.c [12] 449 1731 17 (3.8) 19 (1.1) 3.55 1.83–6.88 < 0.0001
Ferster et al. [13] 1206 305,330 46 (3.8) 8224 (2.7) 1.43 1.07–1.93 0.017
Jeyakumar et al.b [14] 485 673 5 (1.0) 5 (0.7) 1.39 0.40–4.81 0.75

ID = ibuprofen given.
NID = no Ibuprofen given.
a
Two non-ibuprofen bleed rates combined into 1.
b
Some ibuprofen patients used narcotics for pain control.
c
Secondary PTH only.

narcotics as needed for pain control.
Spektor et al. [21] identified significant predictors of post-operative
bleeding including recurrent tonsillitis as an indication for surgery and
older age of the patient. Even though there was a significant difference
in indications between our ID and NID groups, we still found no sig-
nificant difference in bleed rates among our 3 indication categories
(OSA, recurrent tonsillitis, and all others). However, we did find a
significant increase in bleeding in our older patient population
(9–18 years old). Pfaff et al. [10] similarly found age to be an in-
dependent risk factor for post-tonsillectomy hemorrhage, but they went
on to note no significant difference in bleed rates between ibuprofen
and non-ibuprofen groups when age was held constant. This is similar
to our study in which logistical regression analysis also found age to
contribute to bleeding (P = 0.001) but with age held constant bleed
rate differences between ibuprofen and non-ibuprofen groups was in-
significant (95% CI 0.99–3.46, P = 0.053).
However, when we focused attention solely on the 9–18 year old
group and analyzed bleed rates with respect to ibuprofen prescription at
discharge, we found a significant difference. The bleeding rate in the
oldest group was highest of all of our age groups, as expected. Our
results demonstrated a doubling of bleed rates among those aged
9–18 years who were given ibuprofen post-operatively, raising concern
for future use of ibuprofen post-tonsillectomy in this age group.
Although our group of older children was heavier, they received a lower
mean mg/kg ibuprofen dose as the dose was capped at 600 mg per dose.
We speculate that this may not have been enough of an adjustment to
result in an appropriate systemic dose of the medication in particular
individuals. Whether the significant increase in post-tonsillectomy
bleeding in the older child given ibuprofen is a dose effect requires
more study.
Our results showed no significant difference in bleeding with regard
to gender. This is typical of the literature, for example a much larger
study by Harounian et al. [22] had similar results. We also found no
significant difference in bleed rates with regards to race, which was also
demonstrated by a cross-sectional analysis by Bhattacharyya et al. [23].
Additionally, our regression analysis showed a significant difference
in number of ER visits in those who were discharged with ibuprofen.
This has not been seen in previous studies; it may in part reflect ER
visits for bleeding, but this does not explain the difference completely.
We suspect that this also reflects an issue following a pain control re-
gimen alternating acetaminophen and ibuprofen as anecdotally we
found that many parents did not give the acetaminophen, mis-
understanding the importance of the using both medications.
Our cost data does not show a trend between the groups who were
prescribed ibuprofen or not. Our group is small, and costs are
institution specific. We would need a different kind of study to de-
termine if using ibuprofen makes a difference in total costs for tonsil-
lectomy.
Our study was limited in that the two cohorts were not of equal size
(504 in the ID group versus 269 in the NID group), and the overall
sample size is small. Perhaps more significant relationships would be
identified with larger cohort comparisons. However, with the recent
institution of ibuprofen discharge protocols post-tonsillectomy at our
tertiary facility, there was reduced availability of subjects to include
who underwent tonsillectomy and who were not discharged with ibu-
profen. The retrospective nature of our study was also limiting, as it was
impossible to control for all confounding variables. Data retrieval de-
pended on the medical record keeping and the patient's reported
compliance of prescribed discharge regimen, and variability in patient
reporting of post-tonsillectomy bleeds. Thus, with regards to ibuprofen
use we had to resort to a subjective report from each patient (i.e. at the
1-month follow-up visit).
5. Conclusion
This study shows that discharging older children with ibuprofen for
pain control post-tonsillectomy is associated with a significant increase
in bleeding compared to those in the same age range who were not
discharged with ibuprofen. Further clinical research needs to be per-
formed and alternative post-tonsillectomy analgesic regimens should be
considered in this age group in order to provide a safer post-operative
experience.
Funding
This research did not receive any specific grant from funding
agencies in the public, commercial, or not-for-profit sectors.
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