Effect of Paracetamolprednisolone Versus Paracetamolibuprofen On Post-Operative Recovery After Adult Tonsillectomy

You might also like

Download as pdf or txt
Download as pdf or txt
You are on page 1of 12

Accepted Manuscript

Effect of changing postoperative pain management on bleeding


rates in tonsillectomy patients

Alexandra C.G. Fonseca, Margaret I. Engelhardt, Zhen J. Huang,


Zi Yang Jiang, Sancak Yuksel, Soham Roy

PII: S0196-0709(18)30190-X
DOI: doi:10.1016/j.amjoto.2018.03.028
Reference: YAJOT 2004
To appear in:
Received date: 26 February 2018

Please cite this article as: Alexandra C.G. Fonseca, Margaret I. Engelhardt, Zhen J.
Huang, Zi Yang Jiang, Sancak Yuksel, Soham Roy , Effect of changing postoperative pain
management on bleeding rates in tonsillectomy patients. The address for the corresponding
author was captured as affiliation for all authors. Please check if appropriate. Yajot(2017),
doi:10.1016/j.amjoto.2018.03.028

This is a PDF file of an unedited manuscript that has been accepted for publication. As
a service to our customers we are providing this early version of the manuscript. The
manuscript will undergo copyediting, typesetting, and review of the resulting proof before
it is published in its final form. Please note that during the production process errors may
be discovered which could affect the content, and all legal disclaimers that apply to the
journal pertain.
ACCEPTED MANUSCRIPT

Title

Effect of Changing Postoperative Pain Management on Bleeding Rates in Tonsillectomy Patients

Authors

Alexandra C.G. Fonseca, BSa; Margaret I. Engelhardt, BSa; Zhen J. Huang, MD, MBAa; Zi Yang Jiang,

MDa; Sancak Yuksel, MDa; Soham Roy, MDa

T
IP
a

CR
McGovern Medical School at the University of Texas Health Science Center at Houston, Department of

Otorhinolaryngology, 6431 Fannin Street, Houston, TX 77030, United States

Short Running Title


US
AN
Postoperative Management of Tonsillectomies
M

Financial Support or Funding


ED

This research did not receive any specific grant from funding agencies in the public, commercial, or not-

for-profit sectors.
PT
CE

Correspondence

Correspondence, reprint requests, and proofs should be sent to Soham Roy, MD, Department of
AC

Otorhinolaryngology, University of Texas Health Science Center at Houston McGovern Medical School,

6431 Fannin Street, Houston, TX 77030. E-mail: soham.roy@uth.tmc.edu, telephone: 713-500-5410, fax:

713-383-3727.

Notes

No conflicts of interest or financial disclosures to report.


ACCEPTED MANUSCRIPT

Abstract

Purpose: To review rates of post-tonsillectomy hemorrhage (PTH) at a quaternary medical center,

including the impact of narcotic versus nonsteroidal anti-inflammatory drug (NSAID) postoperative pain

management.

Materials and Methods: A retrospective review was performed of tonsillectomies conducted at a single

T
institution between 1/1/2013 and 1/1/2017. The rates of PTH and subsequent intervention were

IP
calculated. These were categorized into patients having surgery pre- and post-July 1, 2015, the former

CR
group receiving narcotics and the latter ibuprofen with acetaminophen.

Results: Of 1351 total tonsillectomies, 3.04% had PTH requiring return to the hospital. 0.74% required

US
no further surgical intervention, whereas 2.30% required secondary surgical control. The bleed rate prior

to July 2015 was 3.15%, with 1.05% non-surgical bleeds and 2.10% requiring surgery. Post-July 2015,
AN
the bleed rate was 2.92%, with 0.44% non-surgical bleeds and 2.49% requiring surgery. There were no

statistically significant differences between the two groups with respect to overall, non-surgical, and
M

surgical hemorrhage rates (p>0.05). Of the total bleeds, the need for secondary surgery in the narcotic
ED

group was 66.7% and 85% in the NSAID group (p=0.18). During the study period, 36 patients with PTH

had their initial tonsillectomy performed at outside institutions; 53% required surgical intervention.
PT

Conclusions: Secondary hemorrhage remains a significant cause of morbidity in post-tonsillectomy


CE

patients, often requiring surgical intervention. This review found no increased bleeding risk associated

with use of ibuprofen and acetaminophen as opposed to narcotic pain relief.


AC

Keywords

tonsillectomy, post-tonsillectomy hemorrhage, NSAID, ibuprofen

Level of Evidence

2b
ACCEPTED MANUSCRIPT

Introduction

Tonsillectomies remain one of the most commonly performed surgeries, with more than half a million

performed each year in patients under the age of fifteen1. Post-tonsillectomy hemorrhage (PTH) and

respiratory complications are among the most common complications following surgery2; in light of these

risks, surgeons must choose a pain regimen that provides adequate analgesia while maintaining an

T
acceptable safety profile. In August 2012, the U.S. Food and Drug Administration contraindicated the

IP
use of codeine in children for pain management following tonsillectomy due to the risk of respiratory

depression2. Continued concern over narcotic-induced respiratory depression resulted in a shift away

CR
from the use of all narcotics in pediatric tonsillectomy patients in 2015 in favor of a regimen of

US
acetaminophen plus ibuprofen. Our study sought to determine the rates of PTH and need for subsequent

intervention at a quaternary medical center as a means to evaluate the impact of narcotic versus
AN
nonsteroidal anti-inflammatory drug (NSAID) postoperative pain management on hemorrhage risk.
M

Materials and Methods


ED

A retrospective review was performed of all tonsillectomies conducted at a single institution between

January 1, 2013 and January 1, 2017. These were categorized into patients having surgery pre- and post-
PT

July 1, 2015. The cohort of patients treated prior to July 1, 2015 were prescribed narcotics as adjunctive
CE

management for postoperative pain (acetaminophen with hydrocodone). This group was compared to

those treated after July 1, 2015, who were given alternating acetaminophen and ibuprofen for pain
AC

without an added narcotic option. This regimen shift at our institution was applied to both adult and

pediatric patients. The rates of PTH and subsequent surgical intervention or non-operative management

were calculated. Risk ratios with associated 95% confidence intervals (95% CI) and p-values were

calculated by dividing the bleeding risk resulting from NSAID use by the bleeding risk of narcotics in

order to analyze the consequences of changes in post-surgical pain management.


ACCEPTED MANUSCRIPT

Results

During the 4-year study period, a total of 1351 tonsillectomies were performed at our institution by 18

otolaryngologists (Table 1). The majority (71%) of these tonsillectomies were conducted by three high

volume pediatric otolaryngologists. For this review, only total tonsillectomy procedures were considered,

with or without other surgical procedures including adenoidectomy, tympanostomy tube placement or

T
other procedures. Intracapsular tonsillectomy procedures were excluded. 1105 (81.8%) of the

IP
tonsillectomies were performed on children under the age of 18, and 246 (18.2%) were performed on

CR
adults. Patient age at surgery ranged from 3 months to 83 years, with an average age of 11.8 years. Of

the total, 41 patients (3.04%) had PTH requiring return to the hospital. Of these patients, 21 (51.2%)

US
were male and 20 (48.8%) were female. Age at the time of initial surgery for patients experiencing PTH

ranged from 2 to 51 years, with an average age of 13.5 years. 32 (78.1%) of these patients were children
AN
and 9 (22.0%) were adults. The risk of PTH in the pediatric population was 2.89% compared to 3.66% in

adults; the difference between these was not statistically significant (p=0.53).
M
ED

Ten patients with PTH required no further surgical intervention, whereas 31 required secondary surgical

control. These numbers reflect a 0.74% total non-surgical bleed rate and a 2.30% surgical bleed rate. The
PT

bleed rate prior to July 2015 was 3.15%, with 1.05% non-surgical bleeds and 2.10% of the patients
CE

requiring surgery. Post-July 2015, the bleed rate was 2.92%, with 0.44% non-surgical bleeds and 2.49%

requiring surgery. There were no statistically significant differences between the two groups with respect
AC

to overall, non-surgical, and surgical hemorrhage rates (p=0.81, 0.20, and 0.64 respectively). Of the total

bleeds, the need for secondary surgery in the narcotic group was 66.7% and 85% in the NSAID group. A

non-statistically significant difference exists in the percentage of PTH requiring surgical intervention

between the two cohorts (p=0.18). In addition to the 41 PTH patients who returned after in-house

tonsillectomies, 36 PTH patients seen at our institution had their initial tonsillectomy performed at outside

institutions. 19 of these patients (53%) required surgical intervention. As these patients received their
ACCEPTED MANUSCRIPT

initial surgery outside our institution, they were not included in the 1351 patients from which our

hemorrhage rates are derived.

Discussion

The recent change in post-tonsillectomy pain management in children from narcotics to NSAIDs has led

T
to debate over the efficacy and safety of this new regimen. Regarding tonsillectomy, otolaryngologists

IP
are primarily concerned with the potential of NSAIDs to cause increased intraoperative blood loss, more

CR
frequent postoperative hemorrhage and their associated complications, and an increased need for further

surgical intervention2. As NSAIDs inhibit platelet aggregation and can prolong bleeding time, their safety

US
in tonsillectomy patients postoperatively has been controversial in large part due to the risk of PTH3.

However, an increased risk of postoperative bleeding and surgical intervention in the pediatric population
AN
has not been confirmed2. Our study of 1351 tonsillectomy patients sought to review the rates of PTH at a

quaternary medical center between the years 2013 and 2017, specifically addressing the impact of
M

narcotic pain medications without NSAIDS, compared to NSAID postoperative pain management without
ED

the use of narcotics.


PT

Previous studies have similarly sought to evaluate the impact of NSAID use in post-tonsillectomy
CE

patients, with mixed results. A prospective, randomized, double-blinded study by Harley et al. in 1998

concluded that acetaminophen with codeine is more efficacious and safe than ibuprofen4. Their small
AC

study of 27 children demonstrated superior pain relief on postoperative days 1 and 3 with codeine, while

ibuprofen was associated with an increased rate of PTH and a longer need for medication for pain

control4. In 2015 D’Souza et al. performed a retrospective chart review to investigate the risk of post-

tonsillectomy hemorrhage in children who received acetaminophen with ibuprofen compared to

acetaminophen with narcotics3. The NSAID group demonstrated a higher rate of PTH occurring within 24

hours of surgery compared to the narcotic group, with 2% and 0.12% respectively (p<0.0001)3. The rate

of PTH occurring greater than 24 hours after surgery in the NSAID group was also higher at 3.8%
ACCEPTED MANUSCRIPT

compared to 1.1% in the narcotic group (p<0.001)3. Similarly, the NSAID group had a greater need for

additional surgical intervention, representing 1.6%; this was compared to 0.5% in the narcotic group (p =

0.01)3. Of note, although the ibuprofen group demonstrated an increased rate of PTH, the overall rate

remained within the normal national average3.

T
A 2014 retrospective medical record review by Mattos et al. also sought to compare the safety and

IP
efficacy of acetaminophen plus ibuprofen against that of opioids in children following tonsillectomy5. No

CR
statistically significant difference in the rate of postoperative hemorrhage was found when the group

prescribed ibuprofen and the no ibuprofen group were compared, with hemorrhage rages of 8.4% and

US
8.2%, respectively5. No difference was found in the rate of surgical intervention between the two groups,

with 50% in the ibuprofen and 43.5% in the no ibuprofen group5. However, the five patients who
AN
presented with multiple bleeding episodes were all prescribed ibuprofen, suggesting a possible

association5. A 2003 meta-analysis performed by Krishna et al. reported no statistically significant


M

increase in risk of PTH with the use of nonaspirin NSAIDs, although an increased risk associated with the
ED

use of aspirin was identified6.


PT

Finally, a pair of meta-analyses performed in 2013 demonstrated no increased bleeding risk with
CE

NSAIDs. A Cochrane review by Lewis et al. involving 15 studies totaling 1101 pediatric patients found

non-significant increases in the risk of surgical and non-surgical PTH resulting from NSAID therapy7.
AC

The authors of that study concluded insufficient evidence exists to exclude an increased risk of PTH when

NSAIDs are used in the pediatric population. The second analysis by Riggin et al. involving 36 studies

comprising 1747 pediatric patients and 1446 adults found no increased risk of PTH, readmission, or

secondary operation in either population due to the use of NSAIDs over narcotics8.

Our sample of 1351 adult and pediatric patients found no statistically significant differences between the

use of narcotics versus NSAIDs and acetaminophen with respect to overall, non-surgical, and surgical
ACCEPTED MANUSCRIPT

hemorrhage rates. A non-significant increase in the likelihood of a patient with PTH requiring a second

operation for hemorrhage control was found; this increase may suggest that there is a higher risk of more

severe bleeding in patients receiving ibuprofen, which was similarly demonstrated in a recent

retrospective study performed by Mudd et al9. Despite this non-significant increase in the risk of

operative intervention, our data suggest that avoidance of narcotics, using only acetaminophen and

T
ibuprofen, may represent a reasonable option for postoperative pain management. Of interest, our study

IP
found no statistically significant difference in the incidence rate of PTH in the pediatric (2.89%) versus

CR
adult (3.66%) population. While the literature is variable, recent studies have suggested that the risk of

PTH is higher in the adult population – this difference was not identified in our study10,11. Finally, our

US
academic institution managed almost as many PTH patients who had their initial surgery outside our

institution as PTH patients from within our own institution, suggesting that academic and tertiary centers
AN
likely have a higher burden of PTH patients requiring management than other institutions.
M

While our study indicates that NSAIDs offer a safe alternative to narcotics for children undergoing
ED

tonsillectomies, it has several important limitations. First, it was conducted retrospectively and did not

account for varying patient demographics. Patients were not controlled for gender, co-morbid conditions,
PT

or other surgical procedures performed at the time of tonsillectomy. Second, data was obtained from
CE

tonsillectomies performed by various surgeons within our department, allowing for potential differences

in surgical technique and skill that were not accounted for in the data analysis. Third, as the study was
AC

conducted retrospectively, patient adherence to the prescribed postoperative analgesic regimen could not

be assessed. Additionally, we did not control for any post-discharge changes to the medication regimen

that may have occurred.


ACCEPTED MANUSCRIPT

Conclusion

Secondary hemorrhage remains a significant cause of morbidity in post-tonsillectomy patients, often

requiring surgical intervention. This retrospective review found no increased bleeding risk associated

with use of ibuprofen and acetaminophen as opposed to narcotic pain relief.

T
IP
CR
US
AN
M
ED
PT
CE
AC
ACCEPTED MANUSCRIPT

References

1. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory Surgery in the United States, 2006. US Department

of Health and Human Services, Centers for Disease Control and Prevention; 2009.

2. Lauder G, Emmott A. Confronting the challenges of effective pain management in children

following tonsillectomy. International Journal of Pediatric Otolaryngology 2014;78(11):1813-1827.

3. D’Souza JN, Schmidt RJ, Xie L, Adelman JP, Nardone HC. Postoperative nonsteroidal anti-

T
IP
inflammatory drugs and risk of bleeding in pediatric intracapsular tonsillectomy. International Journal of

CR
Pediatric Otorhinolaryngology 2015;79(9):1472-1476.

4. Harley EH, Dattolo RA. Ibuprofen for tonsillectomy pain in children: efficacy and complications.

US
Otolaryngology-Head and Neck Surgery 1998;119(5):492-496.

5. Mattos JL, Robison JG, Greenberg J, Yellon RF. Acetaminophen plus ibuprofen versus opioids for
AN
treatment of post-tonsillectomy pain in children. International Journal of Pediatric Otorhinolaryngology

2014;78(10):1671-1676.
M

6. Krishna S, Hughes LF, Lin SY. Postoperative hemorrhage with nonsteroidal anti-inflammatory drug
ED

use after tonsillectomy: a meta-analysis. Archives of Otolaryngology-Head & Neck Surgery

2003;129(10):1086-1089.
PT

7. Lewis SR, Nicholson A, Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs
CE

and perioperative bleeding in paediatric tonsillectomy. Cochrane Database of Systematic Reviews 2013;7.

doi: 10.1002/14651858.CD003591.pub3
AC

8. Riggin L, Ramakarishna J, Sommer DD, Koren G. A 2013 updated systematic review & meta-

analysis of 36 randomized controlled trials; no apparent effects of non steroidal anti-inflammatory agents

on the risk of bleeding after tonsillectomy. Clinical Otolaryngology 2013;38(2):115-129.

9. Mudd PA, Thottathil P, Giordano T, Wetmore RF, Elden L, Jawad AF, Ahumada L, Galvez JA.

Association between ibuprofen use and severity of surgically managed posttonsillectomy hemorrhage.

JAMA Otolaryngology-Head & Neck Surgery 2017;143(7):712-717.


ACCEPTED MANUSCRIPT

10. Shay S, Shapiro NL, Bhattacharyya N. Revisit rates and diagnoses following pediatric

tonsillectomy in a large multistate population. The Laryngoscope 2015;125(2):457-461.

11. Battacharyya N, Kepnes LJ. Revisits and postoperative hemorrhage after adult tonsillectomy. The

Laryngoscope 2014;124(7):1554-1556.

T
IP
CR
US
AN
M
ED
PT
CE
AC
ACCEPTED MANUSCRIPT

Table 1. Comparison of Post-Tonsillectomy Hemorrhage Rates for Narcotic and NSAID Groups

Pain Pain Total Risk Ratio (95% P-value

Management: Management: CI)

Narcotics and NSAIDs and

Acetaminophen Acetaminophen

T
IP
Number of n = 667 n = 684 n = 1351 - -

CR
tonsillectomies Adults: 135 Adults: 111 Adults: 246

performed Children: 532 Children: 573 Children: 1105

US
Total PTH 21 (3.15%) 20 (2.92%) 41 (3.04%) 0.93 (0.51-1.70) 0.81

Adults: 5 Adults: 4 Adults: 9 (3.66%) 0.98 (0.27-3.57) 0.98


AN
Children: 16 Children: 16 Children: 32 (2.89%) 0.92 (0.47-1.83) 0.83

Operative PTH 14 (2.10%) 17 (2.49%) 31 (2.30%) 1.18 (0.59-2.38) 0.64


M

Non-Operative 7 (1.05%) 3 (0.44%) 10 (0.74%) 0.42 (0.11-1.61) 0.20


ED

PTH

Note: Percentages in parentheses represent the rate of hemorrhage with respect to the number of
PT

tonsillectomies performed within the corresponding time period.


CE
AC

You might also like